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Exclusive EU distribution for Stereokem Pharmaceuticals Ltd. India

Today we are pleased to inform you that Stereokem Pharmaceuticals Ltd. India and F. & A. PHARMA have entered into an exclusive distribution agreement for EU market. According to the agreement, Stereokem Pharmaceuticals Ltd. will grant the marketing rights for its active pharmaceutical ingredients to F. & A. PHARMA.
Stereokem Pharmaceuticals Ltd. offers Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), also known as Gliptins. Gliptins are a class of oral hypoglycemics that block DPP-4. They can be used to treat diabetes mellitus type 2. Type 2 diabetes is a chronic metabolic disease that can be caused by pancreas dysfunction, deficiency in insulin secretion, insulin resistance and/or increased hepatic glucose production. It is one of the fastest growing health concerns in the world. Products belonging to this class are:

  • Sitagliptin (FDA approved 2006, marketed by Merck & Co. as Januvia)
  • Vildagliptin (EU approved 2007, marketed in EU by Novartis as Galvus)
  • Saxagliptin (FDA approved 2009, marketed by Bristol Myers Squibb & AstraZeneca as Onglyza)
  • Linagliptin (FDA approved 2011, marketed by Eli Lilly & Boehringer Ingelheim as Trajenta)
  • Alogliptin (FDA approved 2013, marketed by Takeda as Nesina)

The Gliptins are produced in one facility of Srini Pharmaceuticals Ltd. India, which is EU-GMP, WHO-GMP, US-FDA and TGA approved. For all Stereokem products they have signed an exclusive manufacturing agreement with Srini Pharmaceuticals Ltd. The IP, DMF (CTD) and Marketing are owned by Stereokem Pharmaceuticals Ltd.

If you need any further explanations, analytical samples etc. please let us know - we will try to help you in any case. The regulatory documents (EDMF, Tech Pack etc.) can be handed out against Secrecy Agreement.

Looking forward to hearing from you.

Your F. & A. PHARMA team

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F. & A. PHARMA-Handels-GmbH
Registered Office: Bonhoefferring 41, D - 46286 Dorsten, Germany
Phone: +49(0)2369-9261947, Fax: +49(0)2369-9261950
Corporate Office: Weserstrasse 4, D - 45768 Marl, Germany
Phone: +49(0)2365-910640, Fax: +49(0)2365-910641