Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India
The company is already marketing the 4 mg and 10 mg strengths
This is the second US FDA GMP inspection of this facility within one year
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
The company will be submitting the responses to US FDA observations within stipulated timeline
This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization
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
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
The ANDA was filed as 'First to File' submission on NCE-1 date.
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