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.
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)