The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
Certification reinforces energy efficiency, sustainability goals, and green manufacturing across SMT’s Surat and Hyderabad facilities
We will continue to expand our range of purified excipients, offering pharmaceutical companies a dependable partner
ranules now has a total of 38 ANDA approvals from US FDA.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
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