Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
Colchicine tablets are used for the treatment and prevention of gout. It reduces inflammation which causes pain, swelling and other symptoms of gout
To be marketed by Strides Pharma Inc. in the US market
The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
Molnupiravir is an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2
The company has started manufacturing the Sputnik Light vaccine
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Subscribe To Our Newsletter & Stay Updated
