Shilpa Medicare’s Bengaluru units gets USFDA clearance

16 Jul 2025 , 02:18 PM

Shilpa Medicare shares zoomed over 4% after the company announced that it has received an Establishment Inspection Report (EIR) for the Bengaluru unit from the USFDA.

At around 2.06 PM, Shilpa Medicare was trading 4.77% higher at ₹935.10, against the previous close of ₹892.50 on NSE. The counter touched an intraday high of ₹937.10.

The company announced in its filing on July 16 that its Unit VI situated in Dabaspet, Bengaluru, Karnataka has received an EIR with VAI (Voluntary Action Indicated) classification from the USFDA.

USFDA conducted the Good Manufacturing Practices (GMP) inspection from October 24 to October 30 in 2024.

The facility will lay emphasis on manufacturing, packaging, testing, storing, and distributing two types of complex dosage forms—oral dissolving films and transdermal systems.

The company also informed that the unit has already received EMA, Europe approval along with MHRA, UK; SFDA, Saudi Arabia; and TGA, Australia.

Currently, the Bengaluru unit is engaged in supply of oral film products to the United States and other markets. The company has filed for transdermal products in European markets.

Earlier, the company also announced that it has completed the inspection on another unit. The USFDA completed inspection at Shilpa Pharma Lifesciences’ unit situated in Raichur. 

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