 "Ajanta Pharma receives US FDA approval for omeprazole capsules")
The Mumbai-headquartered Ajanta Pharma Ltd has announced the final approval from the US Food & Drug Administration (FDA) and launch of omeprazole and sodium bicarbonate capsules in the US market. The company has launched the product, a generic version of Santarus Inc’s Zegerid, in two strengths - 20 mg/1100 mg and 40 mg/1100 mg.
Omeprazole and sodium bicarbonate capsule is part of an ever-increasing portfolio of products that Ajanta Pharma has developed for the US market. In total, Ajanta has 26 abbreviated new drug application (ANDA) of which it has final approvals for 11 ANDAs, tentative approvals for 1 ANDA and 14 ANDAs are under review with US FDA.
Omeprazole and sodium bicarbonate capsule is part of an ever-increasing portfolio of products that Ajanta Pharma has developed for the US market. In total, Ajanta has 26 abbreviated new drug application (ANDA) of which it has final approvals for 11 ANDAs, tentative approvals for 1 ANDA and 14 ANDAs are under review with US FDA.