Shilpa Medicare Achieves Regulatory Double Win with USFDA and SFDA Approvals

Shilpa Medicare Ltd has announced two major regulatory milestones that underscore its commitment to global compliance and pharmaceutical excellence. The company’s Hyderabad and Bengaluru facilities have successfully cleared inspections and received certifications from top international agencies, positioning Shilpa as a reliable partner in regulated markets.

Inspection closure 

 

Key highlights:

 

The USFDA inspection of Shilpa’s Bio-Analytical Laboratory, Unit VII in Nacharam, Hyderabad, concluded with zero Form 483 observations, indicating full adherence to global regulatory standards.

 

Conducted between February 26 and March 1, 2024, the inspection has now been officially closed with the issuance of the Establishment Inspection Report.

 

The facility has been classified as No Action Indicated (NAI), a rare and commendable outcome that reflects Shilpa’s rigorous quality systems and operational integrity.

 

GMP certification update:

 

Shilpa’s Unit VI facility at Dabaspet, Bengaluru has received Good Manufacturing Practice (GMP) certification from the Saudi Food and Drug Authority (SFDA), further expanding its reach into Middle Eastern markets.

 

The certification covers manufacturing, packaging, testing, storage, and distribution of Oral Mouth Dissolving Films and Transdermal Systems—complex dosage forms that offer enhanced patient convenience and compliance.

This unit is already approved by EMA, MHRA (UK), and TGA (Australia), and supplies products to the US and other regulated regions.

 

Strategic impact:

These dual achievements will enable Shilpa Medicare to deepen its presence in North America, Europe, and the Middle East, while reinforcing its reputation for regulatory excellence and innovation.

 

Sources: Business Standard, CNBC TV18, VBShilpa.com, Angel One