Home CompaniesBiocon Pharmaceutical Biocon gets USFDA nod for generic product

Biocon gets USFDA nod for generic product

by admin
0 comment
ANDA, Biocon , Mycophenolic Acid , USFDA , Food and Drug Administration, Pharma, Industry, News

Summary:

  • Biocon Pharma has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid
  • The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths.

Biotechnology major Biocon on Thursday said its unit has received approval from the US health regulator to market a generic product.

Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths.

ANDA, Biocon , Mycophenolic Acid , USFDA , Food and Drug Administration, Pharma, Industry, News

Biocon receives approval from the US Food and Drug Administration for a generic product.

This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.

Meanwhile, Biocon said on Wednesday that it has been selected for the Dow Jones Sustainability Index (DJSI) in the Emerging Markets (EM) category for its Environmental, Social and Governance (ESG) practices.

The pharma major made a formal submission for Corporate Sustainability Assessment for its listing on the DJSI for the first time this year and made it to the DJSI EM Index with a total sustainability score of 45 as against an industry average of 18, achieving a 93rd percentile position.

About Biocon

Biocon Limited is an Indian biopharmaceutical company that is based in Bangalore, India founded by Kiran Mazumdar-Shaw. The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe. It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon’s biosimilar products are also sold in both bulk and formulation forms in several emerging markets. In contract research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon.

Biocon’s formulations for the Indian market include metabolics, oncology, immunotherapy and nephrology products. Some of Biocon’s key brands in India include INSUGEN (rh-insulin), BASALOG (Glargine), BIOMAb EGFR (Nimotuzumab), BLISTO (Glimepiride + Metformin), CANMAb (Trastuzumab), Evertor (Everolimus), TACROGRAF (Tacrolimus), ALZUMAb(Itolizumab) and KRABEVA (Bevacizumab)

 

For more Information: Sign in Websites for Agrochemical & Pharmaceutical Databases:

Website : https://www.chemrobotics.com/ (Agrochemical Databases)

Website : https://chemroboticspharma.com/  (Pharmaceutical Databases)

You may also like

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Our Company

ChemRobotics is a global Scientific, Technical & Business data intelligence company, especially in the field of Pharmaceutical, Agrochemical, Veterinary and Fine Chemical.

ChemRobotics Times

Subscribe ChemRobotics for the latest updates in the Pharmaceutical, Agrochemical, Veterinary, and Fine Chemical Industries

Laest News

ChemRobotics Pvt. Ltd. © 2023, All Rights Reserved. 

Designed and Developed by Ample eBusiness