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Global Generic
 Product Directory
NOW WITH SUPER GENERIC AND BIOSIMILAR DATA
                 Edition 3, 2011
This is the 3rd edition of the
Global Generic Product Directory
Although not quite as ground breaking as the first edition, this one has MORE products, MORE developers and generated MORE excitement.
It is generally considered better than the first, which is great, as that is what we planned. If you have ideas on how we can keep improving our beloved
directory, please do let us know.
The business process is now even simpler:



Find a product                    Go online to                              Make contact with
you like in the              www.genericlicensing.com                        the developer
   directory

Genericlicensing Limited has been set up to help you do more business, more effectively.
We want you to have access to all the product data you need to license more products; that is why we are dedicated to keeping our database updated
and finding new developers you might be interested in working with.
We want to be the first place you turn to when you think about a new product
We know you are a demanding user, so we're seeking new types and sources of data to add even more depth to our offering. We don't want you go
anywhere else; that keeps us on our toes.
Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!)
We believe in data; you can believe in us.




Asa Cox
Founder, Genericlicensing Limited
asa.cox@genericlicensing.com
skype: asa_cox

Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of
the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
Contents
PRODUCTS                                                                                                     COMPANIES
listed alphabetically (then by company)                                                                      listed alphabetically (then by product)
AS - Azt           ........................ 2 – 31                                                           Ache - Auro ........................ 276 - 301
Bac - But          ........................ 31 – 41                                                          Bata - Bors          ........................ 306 - 347
Cab - Cyt          ........................ 41 – 79                                                          Cadi - Cosc ........................ 351 - 372
Dac - Dyd ........................ 79 – 99                                                                   Demo - Dyna ........................ 375 - 380
Eba - Eze          ........................ 99 – 107                                                         Efar - Euro          ........................ 384 - 392
Fam - Fus ........................ 108 – 121                                                                 Fada - Frat          ........................ 398 - 414
Gab - Gri          ........................ 122 – 132                                                        Gale - Grup          ........................ 416 - 428
Hal - Hyp          ........................ 132 – 136                                                        Hame - Herm ........................ 428 - 436
Iba - Ive          ........................ 136 – 147                                                        IND - Jubi           ........................ 437 - 448
Ket - Ket          ........................ 147 – 148                                                        Kent - KRKA ........................ 450 - 461
LC - Lys           ........................ 151 – 167                                                        Labo - Lupi          ........................ 465 - 470
Mac - Myc ........................ 167 – 187                                                                 Neog - Orch ........................ 474 - 486
Nab - Nys ........................ 187 – 194                                                                 PH&T - Prol ........................ 486 - 496
Oct - Ozy          ........................ 194 – 206                                                        Rafa - Rusa          ........................ 499 - 504
Pac - Pyr          ........................ 206 – 227                                                        Sage - SunP ........................ 505 - 515
Que - Qui          ........................ 227 – 230                                                        Taro - Venu          ........................ 517 - 526
Rab - Rub ........................ 230 – 241                                                                 Wock - YSP ........................ 526 - 532
SA - Sum           ........................ 241 – 251
Tac - Tro          ........................ 251 – 266
Ura - Zal          ........................ 266 – 274




Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
Listings By
PRODUCT
Global Generic
Product directory
                         PRODUCTS
                                                                                                                                                       Dossier   Approved Regulatory
   Molecule Name                           Company                   Form                     Strength                                    Format       Status    Country Status
   A S acid                                Faromed                   Capsule - Pellets        500 mg                                      IOR          Ready     Austria    NRP
   Acarbose                                Batavia                   Tablet                   50mg, 100mg                                 CTD          Ready     IOR        IOR
   Acarbose                                Bioplus                   Tablet                   25 mg, 50 mg, 100 mg                        IOR          In-Dev    N/A        IOR
   Acarbose                                Bluepharm                 Tablet                   25 mg, 50 mg, 100 mg                        CTD          Ready     Portugal   PLG
   Acarbose                                Helm                      Tablet                   50 mg, 100 mg                               CTD          Ready     Germany    NRP
   Acarbose                                IND Swift                 Tablet                   25mg                                        NTA          In-Dev    N/A        IOR
   Acarbose                                IND Swift                 Tablet                   50mg                                        NTA          In-Dev    N/A        IOR
   Acarbose                                Substipharm               Tablet                   50 mg, 100 mg                               CTD          Ready     France     PLG
   Acarbose                                Tecnimede                 Tablet                   50 mg, 100 mg                               CTD          Ready     Portugal   PLG
   Acarbose                                YSP                       Tablet                   25mg                                        ANDA         In-Dev    N/A        IOR
   Acarbose                                YSP                       Tablet                   50mg                                        ANDA         In-Dev    N/A        IOR
   Acarbose                                YSP                       Tablet                   100mg                                       ANDA         In-Dev    N/A        IOR
   Acarbose                                YSP                       Tablet                   50 mg                                       CTD          Ready     Taiwan     PLG
   Acarbose                                YSP                       Tablet                   50mg                                        NTA          Ready     Taiwan     Approved
   Acebrophylline                          Ache Laboratorios         Solution - Oral          5 mg/ml, 10 mg/ml                           IOR          Ready     Brasil     Approved
   Acebrophylline                          Eurofarma                 Syrup                    120 ml                                      IOR          Ready     Brasil     Approved
   Acebutolol                              Hamelnrds                 Tablet                   200 mg, 400 mg                              CTD          Ready     Germany    NRP
   Aceclidine HCl                          Farmigea                  Drops - Eye              2% ( 10 ml)                                 CTD          Ready     Italy      PLG
   Aceclidine HCl + Timolol                Farmigea                  Drops - Eye              0.1% + 0.25% (10 ml)                        CTD          Ready     Italy      PLG
   Aceclofenac                             Anglo-French Drugs        Tablet                   100 mg                                      IOR          Ready     India      Approved
                                           & Industries Ltd
   Aceclofenac                             Astron                    Tablet - Film coated     100 mg                                      CTD          Ready     Spain      PLG
   Aceclofenac                             Batavia                   Tablet                   100mg                                       CTD          Ready     IOR        IOR
   Aceclofenac                             Bioplus                   Tablet                   100 mg                                      IOR          In-Dev    N/A        IOR
   Aceclofenac                             Chhikara Pharma           Tablet                   100 mg                                      NTA          Ready     INDIA      Approved
   Aceclofenac                             Dynamic Lifecare          Tablet                   200 mg                                      IOR          Ready     India      Approved
   Aceclofenac                             Eurofarma                 Gel - Topical            30 mg                                       IOR          Ready     Brasil     Approved
   Aceclofenac                             Eurofarma                 Tablet                   100 mg                                      IOR          Ready     Brasil     Approved
   Aceclofenac                             SuanFarma                 Tablet                   100 mg                                      IOR          Ready     Spain      PLG
   Aceclofenac                             Substipharm               Tablet                   100 mg                                      CTD          Ready     France     PLG


   2        IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
GROW YOUR BUSINESS!
                 LICENSE OTC'S OR BIOSIMILARS
                          • 20 Top Company Profiles

                     • All seeking international partners

                             • No introduction fee's

                               GREG.KINSEY@GENERICLICENSING.COM


                                     Research:
                                     groups of patents.
                                     Development: Approximately 50 products registered; about 20 further in
                                     development.
                                     Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled
                                     manufacturing technology – including electronic batch recording.
                                     Quality:                                                            and
                                     transfer and inventory coverage.
                                     Responsiveness: Global supply chain management services.
                                     Marketing/ Distribution: Major generic player in UK and Israel; fully



We
                                     geared up to win tenders in Germany. Presence in several more markets
          target our goals.          worldwide via distribution partners.
          target our drugs.          Interested in: Contract manufacturing Contract development/Co-development
          time our delivery…           Out-licencing In-licencing Distribution EU-re-analyses/ release
                                                  For more information please visit www.dexcel.com
because timing is everything                      Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
GLOBAL GENERIC
PRODUCT DIRECTORY
                    FEATURED COMPANY
                                 COMPANY NAME           Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP
                                 Wockhardt UK Ltd       Pharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcare
                                                        products to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Export
                                     CITY               and Contract Manufacturing Divisions also in place, this is an exciting time for
                                    Wrexham             Wockhardt UK.
                                                              Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business Development
                                    COUNTRY                     Email: Ashish.Kakabalia@wockhardt.co.uk
                                      UK                    Telephone: +44 (0) 1978 661261

      PACK SHOTS




                                                                                 In-Dev/    1st                                          Reg
  Product                 Form       Strength                        Format     Ready/App App Date    Country     Status        Reg      Date
                                                                                                                                DCP ✔



                                                                                               LY
  Cilostazol              Tab         50 mg, 100 mg                  CTD          In-Dev                          Ready
  Cimetidine              Tab         100 mg, 200 mg,                CTD          Ready    <2008                                None




                                                                                            ON
  Ciprofloxacin                       400 mg, 800 mg                 CTD                                          Validation




                                                      TA
  Ciprofloxacin           Tab         250 mg, 500 mg, 750 mg         CTD          Ready    <2008      UK                        None
  Ciprofloxacin Lactate   Tab         250 mg, 500 mg, 750 mg         CTD                                          Ready




                                                    DA
  Citalopram              Tab         250 mg, 500 mg                 CTD          Ready    Oct-08     Portugal                  None




                                                 LE
  Citalopram              Tab         10 mg, 20 mg, 40 mg            CTD




                              MP
  Clarithromycin          Tab         20 mg                          CTD          App                 Greece                    PL
  Clarithromycin          Tab         250 mg, 500 mg                 CTD          Ready               UK          Pilot Scale   None



                            A
  Clopidrogel             Tab         250 mg, 500 mg                 CTD          App                 Greece      BE Pend.      PL       Dec-09
  Desloratadine
  Desloratadine
  Desloratadine
  Diclofenac
                          S
                          Tab
                          Tab
                          Tab
                          Tab
                                      75 mg
                                      5 mg
                                      2.5 mg, 5 mg
                                      5 mg
                                                                     CTD
                                                                     CTD
                                                                     CTD
                                                                     CTD
                                                                                  Ready
                                                                                  App
                                                                                  Ready
                                                                                  Ready    Oct-08
                                                                                                      UK
                                                                                                      Greece
                                                                                                      UK
                                                                                                                  Status
                                                                                                                                None
                                                                                                                                PL
                                                                                                                                None
                                                                                                                                None
                                                                                                                                         Nov-08
                                                                                                                                         Mar-08


  Diclofenac              Tab         25 mg, 50 mg                   CTD          In-Dev                                        None
GLOBAL GENERIC
PRODUCT DIRECTORY
                    FEATURED COMPANY
                                 COMPANY NAME          A fast-growing multinational group, specialized in manufacturing and marketing of
                                      Hikma            generic, branded and licensed pharmaceutical products globally. Manufacturing
                                  Pharmaceutials       operations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, Saudi
                                      CITY             Arabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundly
                                     Amman             working on expanding to new regions such as Australasia and South America.
                                                             Contact: Contact Name
                                   COUNTRY                     Email: bd@hikma.com
                                    Jordan                 Telephone: Contact Telephone Number

      PACK SHOTS




                                                                               In-Dev/    1st                                         Reg
  Product                 Form       Strength                       Format    Ready/App App Date   Country      Status        Reg     Date
                                                                                                                              DCP ✔



                                                                                             LY
  Cilostazol              Tab        50 mg, 100 mg                  CTD         In-Dev                          Ready
  Cimetidine              Tab        100 mg, 200 mg,                CTD         Ready    <2008                                None




                                                                                          ON
  Ciprofloxacin                      400 mg, 800 mg                 CTD                                         Validation




                                                     TA
  Ciprofloxacin           Tab        250 mg, 500 mg, 750 mg         CTD         Ready    <2008      UK                        None
  Ciprofloxacin Lactate   Tab        250 mg, 500 mg, 750 mg         CTD                                         Ready




                                                   DA
  Citalopram              Tab        250 mg, 500 mg                 CTD         Ready    Oct-08     Portugal                  None




                                                LE
  Citalopram              Tab        10 mg, 20 mg, 40 mg            CTD




                              MP
  Clarithromycin          Tab        20 mg                          CTD         App                 Greece                    PL
  Clarithromycin          Tab        250 mg, 500 mg                 CTD         Ready               UK          Pilot Scale   None



                            A
  Clopidrogel             Tab        250 mg, 500 mg                 CTD         App                 Greece      BE Pend.      PL      Dec-09
  Desloratadine
  Desloratadine
  Desloratadine
  Diclofenac
                          S
                          Tab
                          Tab
                          Tab
                          Tab
                                     75 mg
                                     5 mg
                                     2.5 mg, 5 mg
                                     5 mg
                                                                    CTD
                                                                    CTD
                                                                    CTD
                                                                    CTD
                                                                                Ready
                                                                                App
                                                                                Ready
                                                                                Ready    Oct-08
                                                                                                    UK
                                                                                                    Greece
                                                                                                    UK
                                                                                                                Status
                                                                                                                              None
                                                                                                                              PL
                                                                                                                              None
                                                                                                                              None
                                                                                                                                      Nov-08
                                                                                                                                      Mar-08


  Diclofenac              Tab        25 mg, 50 mg                   CTD         In-Dev                                        None
Listings By
COMPANY
Global Generic
Product directory
                         COMPANY
                                                                                                                                                       Dossier   Approved Regulatory
   Company                  Molecule Name                            Form                     Strength                                    Format       Status    Country Status
   Ache Laboratorios        Acebrophylline                           Solution - Oral          5 mg/ml, 10 mg/ml                           IOR          Ready     Brasil   Approved
   Ache Laboratorios        Adapalene                                Gel - Topical            1% (30 g)                                   IOR          Ready     Brasil   Approved
   Ache Laboratorios        Alprazolam                               Tablet                   0.5 mg                                      IOR          Ready     Brasil   Approved
   Ache Laboratorios        Ambroxol                                 Solution - Oral          3 mg/ml, 6 mg/ml                            IOR          Ready     Brasil   Approved
   Ache Laboratorios        Amiloride + HCTZ                         Tablet                   5 mg + 50 mg                                IOR          Ready     Brasil   Approved
   Ache Laboratorios        Amiodarone                               Tablet                   200 mg                                      IOR          Ready     Brasil   Approved
   Ache Laboratorios        Amlodipine Besilate                      Tablet                   5 mg, 10 mg                                 IOR          Ready     Brasil   Approved
   Ache Laboratorios        Amoxicillin                              Solution - Oral          50 mg / 5 ml, 400 mg / 10 ml                IOR          Ready     Brasil   Approved
   Ache Laboratorios        Atenolol                                 Tablet                   25 mg, 50 mg, 100 mg                        IOR          Ready     Brasil   Approved
   Ache Laboratorios        Atenolol + Chlorthalidone                Tablet                   50 mg + 12.5 mg, 100 mg + 50 mg             IOR          Ready     Brasil   Approved
   Ache Laboratorios        Brimonidine                              Solution -               2 mg/ml                                     IOR          Ready     Brasil   Approved
                                                                     Ophtalmic
   Ache Laboratorios        Bromazepam                               Tablet                   3 mg, 6 mg                                  IOR          Ready     Brasil   Approved
   Ache Laboratorios        Bromopride                               Drops                    4 mg/ml                                     IOR          Ready     Brasil   Approved
   Ache Laboratorios        Bromopride                               Solution - Oral          1 mg/ml                                     IOR          Ready     Brasil   Approved
   Ache Laboratorios        Captopril                                Tablet                   25 mg, 50 mg                                IOR          Ready     Brasil   Approved
   Ache Laboratorios        Carbamazepine                            Tablet                   200 mg                                      IOR          Ready     Brasil   Approved
   Ache Laboratorios        Carbidopa + Levodopa                     Tablet                   25 mg + 250 mg                              IOR          Ready     Brasil   Approved
   Ache Laboratorios        Carbocisteine                            Solution - Oral          20 mg/ml, 50 mg/ml                          IOR          Ready     Brasil   Approved
   Ache Laboratorios        Carvedilol                               Tablet                   3.125 mg, 6.25 mg, 12.5 mg, 25 mg           IOR          Ready     Brasil   Approved
   Ache Laboratorios        Cefadroxil Monohydrate                   Solution - Oral          50 mg/ml, 100 mg/ml                         IOR          Ready     Brasil   Approved
   Ache Laboratorios        Chlorthalidone + Atenolol                Tablet                   12.5 mg + 50 mg, 50 mg + 100 mg             IOR          Ready     Brasil   Approved
   Ache Laboratorios        Ciprofloxacin                            Tablet - Film coated     500 mg                                      IOR          Ready     Brasil   Approved
   Ache Laboratorios        Citalopram                               Tablet - Film coated     20 mg                                       IOR          Ready     Brasil   Approved
   Ache Laboratorios        Cyclobenzaprine                          Tablet                   5 mg, 10 mg                                 IOR          Ready     Brasil   Approved
   Ache Laboratorios        Desonide                                 Cream                    5 mg/g (30 g)                               IOR          Ready     Brasil   Approved
   Ache Laboratorios        Dexamethasone + Tobramycin               Solution -               1 mg + 3 mg / ml                            IOR          Ready     Brasil   Approved
                                                                     Ophtalmic
   Ache Laboratorios        Diclofenac                               Solution - Oral          15 mg/ml                                    IOR          Ready     Brasil   Approved
   Ache Laboratorios        Diclofenac                               Gel - Topical            10 mg/g                                     IOR          Ready     Brasil   Approved


   276      IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
WE'LL DO THE WORK!
 TAKE THE EFFORT OUT OF IN-LICENSING
Give us a brief >> We agree a list of companies & products >>
 We get a licensing offer from them >> You take it from there
                  ASA.COX@GENERICLICENSING.COM
Services Offered
                ✔    Regulatory filings, variations and license maintenance
   ✔    Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA)
                          ✔    Manufacturing GMP inspection preparation
                                    ✔    Manufacturing technical transfers
                                    ✔    Formulation development projects

                Europe – North America – Australasia
                    Expertise is offered both in-house and through industry leading partners.
                           Talk to us about your technical service requirements today.


                               CALL +44 (0)870 7524105
                                    CLIENT.CARE@GENERICLICENSING.COM
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
Email: directory@genericlicensing.com or Phone: +44 8707524105




                        © Copyright 2008-2011

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2011 Global Generic Product Directory Demo

  • 1. Global Generic Product Directory NOW WITH SUPER GENERIC AND BIOSIMILAR DATA Edition 3, 2011
  • 2. This is the 3rd edition of the Global Generic Product Directory Although not quite as ground breaking as the first edition, this one has MORE products, MORE developers and generated MORE excitement. It is generally considered better than the first, which is great, as that is what we planned. If you have ideas on how we can keep improving our beloved directory, please do let us know. The business process is now even simpler: Find a product Go online to Make contact with you like in the www.genericlicensing.com the developer directory Genericlicensing Limited has been set up to help you do more business, more effectively. We want you to have access to all the product data you need to license more products; that is why we are dedicated to keeping our database updated and finding new developers you might be interested in working with. We want to be the first place you turn to when you think about a new product We know you are a demanding user, so we're seeking new types and sources of data to add even more depth to our offering. We don't want you go anywhere else; that keeps us on our toes. Enjoy the 3rd edition, we hope you will love, cherish and share it (ie tell other people about it!) We believe in data; you can believe in us. Asa Cox Founder, Genericlicensing Limited asa.cox@genericlicensing.com skype: asa_cox Legal: All the information contained in the directory has been provided by manufacturers and developers in good faith; Genericlicensing Limited cannot therefore guarantee the accuracy of the data. Any consequential loss cannot be accepted as a result of any business conducted with companies listed or their products.
  • 3.
  • 4. Contents PRODUCTS COMPANIES listed alphabetically (then by company) listed alphabetically (then by product) AS - Azt ........................ 2 – 31 Ache - Auro ........................ 276 - 301 Bac - But ........................ 31 – 41 Bata - Bors ........................ 306 - 347 Cab - Cyt ........................ 41 – 79 Cadi - Cosc ........................ 351 - 372 Dac - Dyd ........................ 79 – 99 Demo - Dyna ........................ 375 - 380 Eba - Eze ........................ 99 – 107 Efar - Euro ........................ 384 - 392 Fam - Fus ........................ 108 – 121 Fada - Frat ........................ 398 - 414 Gab - Gri ........................ 122 – 132 Gale - Grup ........................ 416 - 428 Hal - Hyp ........................ 132 – 136 Hame - Herm ........................ 428 - 436 Iba - Ive ........................ 136 – 147 IND - Jubi ........................ 437 - 448 Ket - Ket ........................ 147 – 148 Kent - KRKA ........................ 450 - 461 LC - Lys ........................ 151 – 167 Labo - Lupi ........................ 465 - 470 Mac - Myc ........................ 167 – 187 Neog - Orch ........................ 474 - 486 Nab - Nys ........................ 187 – 194 PH&T - Prol ........................ 486 - 496 Oct - Ozy ........................ 194 – 206 Rafa - Rusa ........................ 499 - 504 Pac - Pyr ........................ 206 – 227 Sage - SunP ........................ 505 - 515 Que - Qui ........................ 227 – 230 Taro - Venu ........................ 517 - 526 Rab - Rub ........................ 230 – 241 Wock - YSP ........................ 526 - 532 SA - Sum ........................ 241 – 251 Tac - Tro ........................ 251 – 266 Ura - Zal ........................ 266 – 274 Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  • 6. Global Generic Product directory PRODUCTS Dossier Approved Regulatory Molecule Name Company Form Strength Format Status Country Status A S acid Faromed Capsule - Pellets 500 mg IOR Ready Austria NRP Acarbose Batavia Tablet 50mg, 100mg CTD Ready IOR IOR Acarbose Bioplus Tablet 25 mg, 50 mg, 100 mg IOR In-Dev N/A IOR Acarbose Bluepharm Tablet 25 mg, 50 mg, 100 mg CTD Ready Portugal PLG Acarbose Helm Tablet 50 mg, 100 mg CTD Ready Germany NRP Acarbose IND Swift Tablet 25mg NTA In-Dev N/A IOR Acarbose IND Swift Tablet 50mg NTA In-Dev N/A IOR Acarbose Substipharm Tablet 50 mg, 100 mg CTD Ready France PLG Acarbose Tecnimede Tablet 50 mg, 100 mg CTD Ready Portugal PLG Acarbose YSP Tablet 25mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 50mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 100mg ANDA In-Dev N/A IOR Acarbose YSP Tablet 50 mg CTD Ready Taiwan PLG Acarbose YSP Tablet 50mg NTA Ready Taiwan Approved Acebrophylline Ache Laboratorios Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil Approved Acebrophylline Eurofarma Syrup 120 ml IOR Ready Brasil Approved Acebutolol Hamelnrds Tablet 200 mg, 400 mg CTD Ready Germany NRP Aceclidine HCl Farmigea Drops - Eye 2% ( 10 ml) CTD Ready Italy PLG Aceclidine HCl + Timolol Farmigea Drops - Eye 0.1% + 0.25% (10 ml) CTD Ready Italy PLG Aceclofenac Anglo-French Drugs Tablet 100 mg IOR Ready India Approved & Industries Ltd Aceclofenac Astron Tablet - Film coated 100 mg CTD Ready Spain PLG Aceclofenac Batavia Tablet 100mg CTD Ready IOR IOR Aceclofenac Bioplus Tablet 100 mg IOR In-Dev N/A IOR Aceclofenac Chhikara Pharma Tablet 100 mg NTA Ready INDIA Approved Aceclofenac Dynamic Lifecare Tablet 200 mg IOR Ready India Approved Aceclofenac Eurofarma Gel - Topical 30 mg IOR Ready Brasil Approved Aceclofenac Eurofarma Tablet 100 mg IOR Ready Brasil Approved Aceclofenac SuanFarma Tablet 100 mg IOR Ready Spain PLG Aceclofenac Substipharm Tablet 100 mg CTD Ready France PLG 2 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 7. GROW YOUR BUSINESS! LICENSE OTC'S OR BIOSIMILARS • 20 Top Company Profiles • All seeking international partners • No introduction fee's GREG.KINSEY@GENERICLICENSING.COM Research: groups of patents. Development: Approximately 50 products registered; about 20 further in development. Capacity: 3 manufacturing facilities – cutting-edge, computer-controlled manufacturing technology – including electronic batch recording. Quality: and transfer and inventory coverage. Responsiveness: Global supply chain management services. Marketing/ Distribution: Major generic player in UK and Israel; fully We geared up to win tenders in Germany. Presence in several more markets target our goals. worldwide via distribution partners. target our drugs. Interested in: Contract manufacturing Contract development/Co-development time our delivery… Out-licencing In-licencing Distribution EU-re-analyses/ release For more information please visit www.dexcel.com because timing is everything Contact: oren.weininger@dexcel.com, mohitsingh@dexcelpharma.co.uk
  • 8. GLOBAL GENERIC PRODUCT DIRECTORY FEATURED COMPANY COMPANY NAME Wockhardt UK is a diverse pharmaceutical business, created from the merger of CP Wockhardt UK Ltd Pharmaceuticals and The Wallis Laboratory. We are a major supplier of healthcare products to the Retail Pharmacy, Hospital and Grocery sectors. With thriving Export CITY and Contract Manufacturing Divisions also in place, this is an exciting time for Wrexham Wockhardt UK. Contact: Ashish Kakabalia - Head of Pharmacy, GSL & Business Development COUNTRY Email: Ashish.Kakabalia@wockhardt.co.uk UK Telephone: +44 (0) 1978 661261 PACK SHOTS In-Dev/ 1st Reg Product Form Strength Format Ready/App App Date Country Status Reg Date DCP ✔ LY Cilostazol Tab 50 mg, 100 mg CTD In-Dev Ready Cimetidine Tab 100 mg, 200 mg, CTD Ready <2008 None ON Ciprofloxacin 400 mg, 800 mg CTD Validation TA Ciprofloxacin Tab 250 mg, 500 mg, 750 mg CTD Ready <2008 UK None Ciprofloxacin Lactate Tab 250 mg, 500 mg, 750 mg CTD Ready DA Citalopram Tab 250 mg, 500 mg CTD Ready Oct-08 Portugal None LE Citalopram Tab 10 mg, 20 mg, 40 mg CTD MP Clarithromycin Tab 20 mg CTD App Greece PL Clarithromycin Tab 250 mg, 500 mg CTD Ready UK Pilot Scale None A Clopidrogel Tab 250 mg, 500 mg CTD App Greece BE Pend. PL Dec-09 Desloratadine Desloratadine Desloratadine Diclofenac S Tab Tab Tab Tab 75 mg 5 mg 2.5 mg, 5 mg 5 mg CTD CTD CTD CTD Ready App Ready Ready Oct-08 UK Greece UK Status None PL None None Nov-08 Mar-08 Diclofenac Tab 25 mg, 50 mg CTD In-Dev None
  • 9. GLOBAL GENERIC PRODUCT DIRECTORY FEATURED COMPANY COMPANY NAME A fast-growing multinational group, specialized in manufacturing and marketing of Hikma generic, branded and licensed pharmaceutical products globally. Manufacturing Pharmaceutials operations are located in Jordan, Algeria, Egypt, Germany, Italy, Portugal, Saudi CITY Arabia, Tunisia and USA. Active markets include MENA, USA and Europe. Profoundly Amman working on expanding to new regions such as Australasia and South America. Contact: Contact Name COUNTRY Email: bd@hikma.com Jordan Telephone: Contact Telephone Number PACK SHOTS In-Dev/ 1st Reg Product Form Strength Format Ready/App App Date Country Status Reg Date DCP ✔ LY Cilostazol Tab 50 mg, 100 mg CTD In-Dev Ready Cimetidine Tab 100 mg, 200 mg, CTD Ready <2008 None ON Ciprofloxacin 400 mg, 800 mg CTD Validation TA Ciprofloxacin Tab 250 mg, 500 mg, 750 mg CTD Ready <2008 UK None Ciprofloxacin Lactate Tab 250 mg, 500 mg, 750 mg CTD Ready DA Citalopram Tab 250 mg, 500 mg CTD Ready Oct-08 Portugal None LE Citalopram Tab 10 mg, 20 mg, 40 mg CTD MP Clarithromycin Tab 20 mg CTD App Greece PL Clarithromycin Tab 250 mg, 500 mg CTD Ready UK Pilot Scale None A Clopidrogel Tab 250 mg, 500 mg CTD App Greece BE Pend. PL Dec-09 Desloratadine Desloratadine Desloratadine Diclofenac S Tab Tab Tab Tab 75 mg 5 mg 2.5 mg, 5 mg 5 mg CTD CTD CTD CTD Ready App Ready Ready Oct-08 UK Greece UK Status None PL None None Nov-08 Mar-08 Diclofenac Tab 25 mg, 50 mg CTD In-Dev None
  • 11. Global Generic Product directory COMPANY Dossier Approved Regulatory Company Molecule Name Form Strength Format Status Country Status Ache Laboratorios Acebrophylline Solution - Oral 5 mg/ml, 10 mg/ml IOR Ready Brasil Approved Ache Laboratorios Adapalene Gel - Topical 1% (30 g) IOR Ready Brasil Approved Ache Laboratorios Alprazolam Tablet 0.5 mg IOR Ready Brasil Approved Ache Laboratorios Ambroxol Solution - Oral 3 mg/ml, 6 mg/ml IOR Ready Brasil Approved Ache Laboratorios Amiloride + HCTZ Tablet 5 mg + 50 mg IOR Ready Brasil Approved Ache Laboratorios Amiodarone Tablet 200 mg IOR Ready Brasil Approved Ache Laboratorios Amlodipine Besilate Tablet 5 mg, 10 mg IOR Ready Brasil Approved Ache Laboratorios Amoxicillin Solution - Oral 50 mg / 5 ml, 400 mg / 10 ml IOR Ready Brasil Approved Ache Laboratorios Atenolol Tablet 25 mg, 50 mg, 100 mg IOR Ready Brasil Approved Ache Laboratorios Atenolol + Chlorthalidone Tablet 50 mg + 12.5 mg, 100 mg + 50 mg IOR Ready Brasil Approved Ache Laboratorios Brimonidine Solution - 2 mg/ml IOR Ready Brasil Approved Ophtalmic Ache Laboratorios Bromazepam Tablet 3 mg, 6 mg IOR Ready Brasil Approved Ache Laboratorios Bromopride Drops 4 mg/ml IOR Ready Brasil Approved Ache Laboratorios Bromopride Solution - Oral 1 mg/ml IOR Ready Brasil Approved Ache Laboratorios Captopril Tablet 25 mg, 50 mg IOR Ready Brasil Approved Ache Laboratorios Carbamazepine Tablet 200 mg IOR Ready Brasil Approved Ache Laboratorios Carbidopa + Levodopa Tablet 25 mg + 250 mg IOR Ready Brasil Approved Ache Laboratorios Carbocisteine Solution - Oral 20 mg/ml, 50 mg/ml IOR Ready Brasil Approved Ache Laboratorios Carvedilol Tablet 3.125 mg, 6.25 mg, 12.5 mg, 25 mg IOR Ready Brasil Approved Ache Laboratorios Cefadroxil Monohydrate Solution - Oral 50 mg/ml, 100 mg/ml IOR Ready Brasil Approved Ache Laboratorios Chlorthalidone + Atenolol Tablet 12.5 mg + 50 mg, 50 mg + 100 mg IOR Ready Brasil Approved Ache Laboratorios Ciprofloxacin Tablet - Film coated 500 mg IOR Ready Brasil Approved Ache Laboratorios Citalopram Tablet - Film coated 20 mg IOR Ready Brasil Approved Ache Laboratorios Cyclobenzaprine Tablet 5 mg, 10 mg IOR Ready Brasil Approved Ache Laboratorios Desonide Cream 5 mg/g (30 g) IOR Ready Brasil Approved Ache Laboratorios Dexamethasone + Tobramycin Solution - 1 mg + 3 mg / ml IOR Ready Brasil Approved Ophtalmic Ache Laboratorios Diclofenac Solution - Oral 15 mg/ml IOR Ready Brasil Approved Ache Laboratorios Diclofenac Gel - Topical 10 mg/g IOR Ready Brasil Approved 276 IOR (Info on request) PL <12months (PL expected within 12 months) LM (Local Market) PLG (Product License Granted) NRP (No Regulatory Position)
  • 12. WE'LL DO THE WORK! TAKE THE EFFORT OUT OF IN-LICENSING Give us a brief >> We agree a list of companies & products >> We get a licensing offer from them >> You take it from there ASA.COX@GENERICLICENSING.COM
  • 13. Services Offered ✔ Regulatory filings, variations and license maintenance ✔ Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA) ✔ Manufacturing GMP inspection preparation ✔ Manufacturing technical transfers ✔ Formulation development projects Europe – North America – Australasia Expertise is offered both in-house and through industry leading partners. Talk to us about your technical service requirements today. CALL +44 (0)870 7524105 CLIENT.CARE@GENERICLICENSING.COM Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  • 14. Email: directory@genericlicensing.com or Phone: +44 8707524105 © Copyright 2008-2011