Glenmark's North America API business is based out of Mahwah, New Jersey and caters to the US and Canada markets. This business additionally supports its customers for first-to-file opportunities in these markets with its dedicated IP and regulatory teams. It is the main region for most of the new API development and patent filings at Glenmark.
Glenmark’s European API business has a robust portfolio of over 100 products developed by our dedicated R&D team. The product portfolio constitutes of a mix of over 18 APIs with CEPs, 40 APIs which are commercially available along with DMF and more than 40 others in various stages of development. Our customer base includes key global generic companies, pan-European generic companies, national generic companies, contract manufacturers and dossier developers.
The API team in Latin America is based in São Paulo, Brazil. This business has been growing consistently over the years, with a focus on all Latin American markets complying with the regulatory guidelines of ANVISA in Brazil and COFEPRIS in Mexico. Glenmark maintains its market leadership position for Bupropion, Cilostazol and Olmesartan in Latin America.
Glenmark has increased its focus on the Japan API market. As a first step towards our entry into the world’s second biggest market, we have acquired an Accreditation of Foreign Manufacturer (AFM) for the Ankleshwar API manufacturing facility.
We filed our first J-DMF in 2011 and are targeting to enhance our J-DMF portfolio. In addition to this, all our focused products for Japan are screened to check the suitability to meet the Japanese Pharmacopeia requirements and high purity standards.
Rest of the World
Glenmark’s API business has a reach in more than 20 countries in the semi-regulated markets of Asia, Middle East, Africa & CIS, with market leadership in several products including Perindopril, Glimepiride, Etoricoxib & Desloratadine.
The company also has a strong presence in markets such as South Korea, Russia, South Africa & China and is registering new products and catering to the API requirements of major pharmaceutical companies and MNCs in this region.
Glenmark has a strong presence in India with an extensive line of high-quality APIs for both branded generics and generic pharmaceutical companies. We offer our customers a comprehensive and customized package of API with IP and regulatory support. We partner with Indian formulators across the spectrum – right from first-to-file products for highly regulated markets to local products in the Indian market.
In India, Glenmark has a base of over 300 customers with market leadership in many products including Telmisartan, Olmesartan, Glimipride, Rosuvastatin, Lornoxicam and Sertaconazole.