Shilpa Medicare's Unit IV receives Eurasia GMP approval
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
This approval has come from the company's finished dosage form manufacturing facility
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
The product is backed by required scientific proof and comparative bioequivalence studies
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
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