The shares of Shilpa Medicare gained over 4% after the company announced that it has received an Establishment Inspection Report (EIR) for the Bengaluru unit from the US FDA.The company, in an exchange filing on July 16, said that Unit VI, Dabaspet, Bengaluru, Karnataka, India, has received an EIR with VAI (Voluntary Action Indicated) classification from the US FDA. Voluntary Action Indicated is the second-best classification that a plant can get from the USFDA. A VAI is generally issued when a plant receives observations, responds to them, and the regulator believes the response by the company is satisfactory.
The Good Manufacturing Practices (GMP) inspection was conducted from October 24 to October 30 in 2024.
This facility will focus on manufacturing, packaging, testing, storing, and distributing two types of complex dosage forms—oral dissolving films and transdermal systems.Read Also: Shilpa Medicare arm partners with Switzerland-based mAbTree Biologics for new cancer drugThe company also added that the unit has already been approved by EMA, Europe; MHRA, UK; SFDA, Saudi Arabia; and TGA, Australia.
The Good Manufacturing Practices (GMP) inspection was conducted from October 24 to October 30 in 2024.
This facility will focus on manufacturing, packaging, testing, storing, and distributing two types of complex dosage forms—oral dissolving films and transdermal systems.Read Also: Shilpa Medicare arm partners with Switzerland-based mAbTree Biologics for new cancer drugThe company also added that the unit has already been approved by EMA, Europe; MHRA, UK; SFDA, Saudi Arabia; and TGA, Australia.
The Bengaluru Unit currently supplies oral film products to the US and other markets. Transdermal products have been filed in the European market.
Earlier in March, the company announced the completion of the inspection on another unit. The USFDA completed an inspection at Unit-1 of its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd, in Raichur.
The shares of the pharma company are trading 4.86% higher at 11:20. The stock has gained over 14% in the year so far.
Catch live market updates with CNBC-TV18.com’s blog
(Edited by : Asmita pant)
