Shilpa Medicare announced that its Bengaluru manufacturing facility has received regulatory clearance from the United States Food and Drug Administration (USFDA), marking a significant milestone for the Indian pharmaceutical company's international operations. The company's Unit VI, located in Dabaspet, Bengaluru, Karnataka, received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification from the USFDA.
USFDA Inspection and Approval
The USFDA conducted a comprehensive Good Manufacturing Practices (GMP) inspection at the facility from October 24 to October 30, 2024. The VAI classification indicates that the facility meets regulatory standards with minor observations that can be addressed through voluntary corrective actions.
The Bengaluru unit focuses on manufacturing, packaging, testing, storing, and distributing two specialized complex dosage forms: oral dissolving films and transdermal systems. These advanced pharmaceutical formulations represent sophisticated drug delivery technologies that require stringent manufacturing standards.
Market Response and Financial Impact
Following the regulatory announcement on July 16, Shilpa Medicare shares experienced significant market gains. At approximately 2:06 PM, the stock was trading 4.77% higher at ₹935.10, compared to the previous close of ₹892.50 on the National Stock Exchange (NSE). The counter reached an intraday high of ₹937.10, reflecting strong investor confidence in the regulatory milestone.
International Regulatory Portfolio
The Bengaluru facility has established a comprehensive international regulatory footprint beyond the USFDA approval. The unit has already secured approvals from multiple regulatory authorities including the European Medicines Agency (EMA) for Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) for the United Kingdom, the Saudi Food and Drug Authority (SFDA) for Saudi Arabia, and the Therapeutic Goods Administration (TGA) for Australia.
Current Operations and Market Expansion
The facility is currently engaged in supplying oral film products to the United States and other international markets. Additionally, the company has filed applications for transdermal products in European markets, indicating plans for further market expansion with its specialized drug delivery systems.
Broader Regulatory Success
The Bengaluru approval represents part of Shilpa Medicare's broader regulatory success story. The company also announced the completion of inspection at another facility, with the USFDA completing its inspection at Shilpa Pharma Lifesciences' unit situated in Raichur.
In a separate development, Shilpa Medicare's subsidiary, Shilpa Pharma Lifesciences Unit-1, received an EIR from the USFDA with VAI classification following an inspection conducted between March 3-7, 2025. This approval contributed to the company's shares extending gains for the sixth consecutive session, rising 3% in opening trade on May 15.
Additional Regulatory Achievements
The company's biologics division has also achieved regulatory milestones. Shilpa Biologics' site in Dharwad, Karnataka, received European GMP certification for manufacturing test batches based on an inspection conducted between February 18-20, 2025, by the competent authority of Austria. The inspection was notably closed with zero observations, demonstrating the facility's high compliance standards.
Strategic Partnerships and Market Position
In March, Shilpa Biologicals entered into a binding term sheet with Switzerland-based mAbTree Biologics AG for the development, manufacture, marketing, and sale of a new biological entity (NBE), further expanding the company's international partnerships and product portfolio.
The company's stock performance reflects strong market confidence, with shares rising 41% over the past year. The stock has touched a 52-week high of ₹959.95 on September 18, 2024, and a 52-week low of ₹419.10 on June 4, 2024. Currently trading 25.46% below its 52-week high and 70.73% above its 52-week low, the company maintains a market capitalization of ₹6,997.43 crore.
