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Overview of Roche in India F.

Hoffmann-La Roche & Co (FHLR) is one of the world's leading research oriented healthcare groups in the fields of pharmaceuticals and diagnostics. The activities of Roche in India commenced with the import of finished pharmaceutical products and bulk vitamins by Volkart Brothers and subsequently by Voltas Ltd. Later the manufacture of two pharmaceutical specialties -SARIDON and SIROLIN commenced after a Roche entity was incorporated in India. Currently, Roche India operates under 2 divisions: Pharmaceuticals Division: Roche Products (India) Pvt. Ltd. Diagnostics Division: Roche Diagnostics (India) Pvt. Ltd.

After a contractual relationship of 10 years with NPIL (Nicholas Piramal India Limited, now Piramal Healthcare), it was decided by FHLR to end the Frame Co-operation Agreement with NPIL in November 2003. This means that NPIL does not have access to any new ROCHE Pharma products for distribution post November 2003. But, if any locally formulated product is to be launched by Roche after November, 2003, NPIL is to be given the first opportunity subject to Roche requirements of technical standards being met by NPIL and also if NPIL has no product which competes with the Roche product offered. However, pre-1993 Roche products licensed to NPIL may continue to remain with NPIL for a specified period of time. Effective 4th November, 2003, FHLR has appointed a new distributor in India viz. Taksal Pharma Pvt. Ltd. (Taksal) for distribution of FHLR products in India. Taksal presently has distribution rights in India for products such as CellCept, Zenapax, Cymevene, Mabthera, Xeloda, Herceptin, Pegasys, Fortovase. In addition, Taksal currently has distribution rights for Recormon, Neupogen, Roferon, Vesanoid. Roche offers products in the following areas: Therapeutic Area Brand Name AvastinTM MabThera

Generic Name Bevacizumab Rituximab Trastuzumab Capecitabine

Class of Drug Anti-neoplastic agent Anti-neoplastic agent Anti-neoplastic agent Anti-neoplastic agent Anti-neoplastic agent Anti-neoplastic agent

Herceptin Xeloda

Oncology

Tarceva Roferon-A

Erlotinib Interferon alfa-2a Filgrastim Epoetin beta

Neupogen NeoRecormon

Hematopoietic growth factor (Cytokines) Anti-anaemic agent


Bisphosphonate Drugs for treatment of bone diseases

Bondronat

Ibandronic acid

Overview of Roche in India Therapeutic Area

Brand Name Vesanoid

Generic Name Tretinoin

Class of Drug Retinoid (Differentiation inducing agent)

Neulastim Cymevene Invirase

Pegfilgrastim Ganciclovir Saquinavir

Hematopoietic Growth Factor Antiviral Antiviral Direct acting anti-viral Immunostimulating Agent / Cytokine Anti-viral Anti-viral Anti-viral Immunosuppressant; inosine monophosphate dehydrogenase (IMPDH) inhibitor

Copegus Virology Pegasys

Ribavirin Peginterferon alfa-2a 40 KD Oseltamivir phosphate Valganciclovir Interferon alfa-2a Mycophenolate Mofetil

Tamiflu Valcyte Roferon-A

CellCept NeoRecormon Nephrology (Transplant and Anemia) Mircera

Epoetin beta

Anti-anaemic agent

Methoxy polyethylene glycol-epoetin beta Valganciclovir

Continuous Erythropoietin Receptor Activator

Valcyte

Anti-viral Recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass Biological anti-CD-20 monoclonal antibody for rheumatoid arthritis Peripherally acting anti-obesity agent Bisphosphonate Drugs for treatment of bone diseases

Actemra Rheumatology MabThera

Tocilizumab

Rituximab Xenical Bonviva

Orlistat Ibandronic acid

Primary Care

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