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Shilpa Medicare Unit IV Receives US FDA Form 483 with Eight Findings

Synopsis:


Shilpa Medicare Ltd’s Unit IV (Jadcherla, Telangana) completed a 10-day US FDA inspection ending 21 Nov 2025 and received a Form 483 citing eight non-repeat observations; US sales from this plant were under 1% in H1 FY26 and under 5% in FY24-25.


Source:
 Shilpa Medicare Limited Press Release (NSE Exchange Fillings) | Published on Nov 22, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release of Shilpa Medicare Limited (NSE Exchange Filings), the company revealed that its manufacturing facility, Unit IV, located at Jadcherla in Telangana, India, was subjected to a ten-day inspection from the U.S. Food and Drug Administration (US FDA), which was completed on 21 November 2025. The inspection concluded with a Form 483 containing eight inspectional observations, none of which were identified as repeat observations. The facility is authorised for the manufacture, packaging, testing, storage and/or distribution of sterile injectable products as well as oral tablets and capsules. 

The company noted that U.S. sales of products manufactured at this facility accounted for less than 1% of total sales in the first half of FY25-26, and less than 5% of total sales in FY24-25. The facility received approvals from regulators in addition to US FDA, which includes the European Medicines Agency (EMA), Health Canada, Anvisa (Brazil) and the Therapeutic Goods Administration (TGA) of Australia. The company further mentioned that it will respond to the observations within the required timeframe.

Also read: Lupin Gets US FDA Form-483 With Seven Observations at the Goa Unit

SHILPA MEDICARE LTD

Trade

353.152.54 (0.72 %)

Updated - 24 November 2025
353.50day high
DAY HIGH
344.65day low
DAY LOW
51570
VOLUME (BSE)

Key Takeaways

  • Inspection period: 10 days, ending 21 November 2025.

  • Facility: Unit IV, Jadcherla, Telangana.

  • Outcome: Form 483 with eight non-repeat observations.

  • U.S. sales from plant: <1% of total in H1 FY26; <5% of total in FY24-25.

  • Facility approvals: EMA, Health Canada, Anvisa, TGA.

Also read: Tata Chemicals Approves ₹910 Crore Plant Expansions at Mithapur & Cuddalore

Facility and Sales Data Table

Item

Details

Plant location

Unit IV, Jadcherla, Telangana

Inspection authority

U.S. Food and Drug Administration

Inspection duration

10 days

Form 483 observations

Eight

Repeat observations

None

U.S. sales contribution (H1 FY26)

Less than 1%

U.S. sales contribution (FY24-25)

Less than 5%

Regulatory approvals held

EMA, Health Canada, Anvisa (Brazil), TGA (Australia)

Operational Implications

The inspection and findings invite questions with respect to operational controls in the facility. At the same time, although the unit is approved by multiple global regulators the issuance of eight observations by US FDA indicates there are areas that require remediation. In supporting a plant supplying to established markets with sterile injectables and oral dosage forms, compliance with current Good Manufacturing Practice (CGMP) requirements is imperative. Even if the contribution of U.S.-market sales from this unit is small (less than 1% in H1 FY26 and less than 5% in FY24-25), the outcome of the inspection may materially impact media production, regulatory submissions for market access for this facility.

Share Price Update

Shilpa Medicare Limited share price stands at ₹350.60 per share on the BSE as of 21 November 2025 at 15:30 PM IST, down by 1.60%.

Published Date : 24 Nov 2025

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