Shares Surge, Confidence Soars—Shilpa’s USFDA Win Reinforces Global Credibility

Image Source: The Economic Times

Shilpa Medicare Ltd. has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (USFDA) for its Unit VI facility located in Dabaspet, Bengaluru. This marks the formal closure of the Good Manufacturing Practice (GMP) inspection conducted between October 24–30, 2024.

Key highlights:

The VAI classification confirms that while minor procedural observations were made, no critical violations were found
The facility specializes in Oral Dissolving Films and Transdermal Systems, with existing approvals from EMA (Europe), MHRA (UK), SFDA (Saudi Arabia), and TGA (Australia)
The unit currently supplies oral film products to the US and other regulated markets, while transdermal products are under review in Europe
The inspection outcome reinforces Shilpa’s compliance standards and strengthens its position as a trusted global supplier
Investor sentiment surged following the announcement, with shares rising nearly 5% to ₹934.95 on NSE, pushing market capitalization to ₹91.38 billion
The company’s P/E ratio stands at 116.29, reflecting high growth expectations in specialty pharma and advanced drug delivery systems

Strategic Implications

This regulatory clearance is expected to unlock new commercial opportunities, particularly in the US market. It also enhances Shilpa Medicare’s credibility in global CDMO partnerships and oncologyfocused formulations.

Sources: Business Upturn, The Health Master, Indian Pharma Post, EquityPandit.