Dr. Reddy’s Lab
has said that USFDA has lifted a warning letter on its formulations manufacturing facility at Duvvada. This site was included in the warning letter received from USFDA in November, 2015. Subsequently, the site was audited by USFDA in March, 2017 but the warning letter stayed. The site was again audited in October, 2018 and based on company’s responses, USFDA has classified the site’s status as Voluntary Action Initiated (VAI). This means that there is no adverse action on the plant and warning letter is as good as lifted.
In another development, Biocon
has said that USFDA conducted two pre-approval inspections of its manufacturing facilities in Bengaluru. The pre-approval inspection of its Oral Solid Dosage Facility was conducted between Feb 11 to 15, 2019 and there was no form 483.
The pre-approval inspection of its additional new injectable manufacturing line, for a biologic drug product was inspected between Feb 7 to 15, 2019 and resulted in a form 483 with two observations. The nature of the observations is not known at this time. Notably, Trastuzumab and Pegfilgrastim Biosimilars are already approved by USFDA, while Glargine is filed from Malaysian facility. The product for which this inspection was conducted is not disclosed. We see this positively as it indicates that the company is close to getting a new product approval.