Marksans Pharma 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.
Pregabalin capsules (RLD Lyrica) had estimated annual sales of $263 million in the U.S. (IQVIA MAT March 2022).
Marksans Pharma together with its subsidiaries operates as an integrated international pharmaceutical company. The company’s business is distribution of pharmaceutical products.
