Natco Pharma has received final approval from the U.S. Food and Drug Administration (USFDA) for Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base).
These Tablets will be marketed in the USA by Natco’s marketing partner Lupin, as generic versions of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec Tablets, 100mg and 400mg.
Imatinib Mesylate Tablet is indicated primarily for the treatment of patients with specific types of Chronic Myeloid Leukemia (CML). Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately $655 million in the US (IQVIA MAT December 2018).
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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