Drug Approval | August 03, 2022
Strides receives USFDA approval for Cyclosporine Softgel Capsules
Strides is the first Indian company to get approval for the product.
Strides is the first Indian company to get approval for the product.
Manish led SeQuent since 2014 and played a major role in transforming the company
Both manufacturing facilities are based out of Benguluru, India
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
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