Marksans Pharma Pregabalin Capsules get USFDA okay
Mumbai: Marksans Pharma Limited has announced that the company has received final approval from US Food & Drugs Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, of Upjohn US 2 LLC.
The medicine is indicated in relieving pain resulting from nerve damage because of diabetes, shingles, spinal cord injury, or other conditions.
Pregabalin capsules (RLD Lyrica) had estimated annual sales of USD 263 million in the U.S. (IQVIA MAT March 2022).
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Marksans Pharma, headquartered at Mumbai (India) is a global pharmaceutical company.
The company's key focus areas lie in the OTC & prescription drugs that have wide-ranging applications across fields like Oncology, Gastroenterology, Antidiabetic, Antibiotics, Cardiovascular, Pain Management, Gynaecology, among others.
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