Drug Approval | April 29, 2025
IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
This approval authorizes the company to export Ibuprofen to the Chinese markets
This approval authorizes the company to export Ibuprofen to the Chinese markets
Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis
The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru
The inspection conducted by EDQM at its Visakhapatnam facility
Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
This product will be launched through Granules Consumer Health (GCH) division
With this, the company can start selling Ibuprofen in the European markets.
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)
Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg
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