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Biocon recalls 3,665 bottles of antifungal drug in US for failed degradation specifications

USFDA noted that the New Jersey-based Biocon Pharma Inc is recalling the affected lot due to โ€˜Failed Impurities/Degradation Specifications: High Out Of Specification degradation resultsโ€™.
Biocon Pharma Biocon Pharma Inc Enforcement Report Posaconazole Delayed Release Tablets New Jersey Based Biocon Pharma Inc Degradation Specifications

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Biocon gets USFDA nod for generic product

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
Biocon Pharma Drug Administration Mycophenolic Acid Business News

Celgene Sues Over Cancer Treatment Drug Patent

Health your username 8 hours ago On Friday, Celgene Corporation filed a complaint in the District of New Jersey. The case was filed against Biocon Pharma Inc. The action focuses on potential patent infringement regarding ten patents held by Celgene which would potentially be infringed upon by a potential generic drug created by Biocon. The patents address methods for treating cancer, specifically multiple myeloma and related blood and bone marrow cancers. The patents resulted in a drug regimen...
New Jersey United States Saul Ewing Arnstein Lehr Celgene Corporation Biocon Pharma Inc Biocon Pharma

Biocon Pharma Limited receives GMP compliance certificate from MHRA, UK

Biocon Pharma Limited receives GMP compliance certificate from MHRA, UK Posted On: 2021-04-11 20:08:53 (Time Zone: Arizona, USA) Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received a certificate of Good Manufacturing Practice (GMP) compliance from the Medicines & Healthcare products Regulatory Agency (MHRA), the United Kingdom (UK), for its manufacturing facility at Biocon Park in Bengaluru. The certificate, which includes manufacturing and packaging of tablets...
United States United Kingdom Biocon Pharma Regulatory Agency Pharma Limited Time Zone

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