USFDA Conducts Pre-Approval Inspection at Shilpa Medicare Unit VI in Bengaluru
Shilpa Medicare Limited reported that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at its Unit VI facility located in Dabaspet, Bengaluru, Karnataka. The inspection took place from May 25, 2026, to May 29, 2026.The facility is dedicated to the manufacturing, packaging, labelling, and testing of specialized finished dosage forms, including oral dispersible/dissolving films and transdermal patches.
The inspection concluded with the issuance of an FDA Form 483, which noted five procedural observations. The company stated that none of these observations were categorized as repeat observations or related to data integrity.
Inspection Details
According to the company's statement, the following details summarize the USFDA inspection action:| Authority | Inspection Type | Dates | Findings |
|---|---|---|---|
| United States Food and Drug Administration (US FDA), USA | Pre-Approval Inspection (PAI) | May 25, 2026, to May 29, 2026 | Issued Form 483 with 5 procedural observations. |
Unit VI has a robust regulatory background, having previously undergone a USFDA GMP inspection and currently holding a Voluntary Action Indicated (VAI) status. Beyond USFDA approval, the unit also maintains accreditations from several international bodies, including Europe-EMA, Saudi Arabia-SFDA, UK-MHRA, and Australia-TGA.
Shilpa Medicare Limited confirmed that the company will submit a comprehensive response to the procedural observations within the stipulated timeline, detailing appropriate corrective and preventive actions.
The company maintains that the development is not expected to have any material impact on its current business operations or existing supplies from the facility.
SHILPAMED Stock Price Movement
On Friday, Shilpa Medicare Limited shares edged higher, gaining 0.65% to settle at ₹498.95. The stock traded on a volume of 1.06 million shares, moving throughout the day within a range of ₹491 to ₹509.8.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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