Drug Approval | November 19, 2022
Strides receives USFDA approval for Potassium Chloride Oral Solution
The approval further strengthens the Potassium Chloride franchise for the company.
The approval further strengthens the Potassium Chloride franchise for the company.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Strides is the first Indian company to get approval for the product.
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)
The company has posted net loss of Rs. 460.21 crores for the Financial Year ended March 31, 2022.
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
They will commercialize molnupiravir in the international markets
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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