Hyderabad-based Aurobindo Pharma has got the US Food & Drug Administration (USFDA) approval for manufacturing and marketing Ibandronate Sodium injection and Omeprazole Delayed-release capsules.
Treatment for osteoporosis
The Ibandronate Sodium injection is indicated for treatment of osteoporosis in postmenopausal women. It is bio-equivalent and therapeutically equivalent to the reference listed product (RLP), Boniva of Hoffmann-La Roche.
14 ANDAs
With this, Aurobindo Pharma has 14 abbreviated new drug application (ANDAs) approved out of its Unit-IV formulation facility in Hyderabad for manufacturing general injectable products, a release from the company said.
Duodenal ulcer
Omeprazole Delayed-release capsules, used in short-term treatment of active duodenal ulcer in adults, is bio-equivalent and therapeutically equivalent to the RLP, Prilosec Delayed-release capsules of AstraZeneca Pharmaceuticals.
Market size
The product had an estimated market size of $422 million in the 12 months ended June 15.
This is the 43rd ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing Oral Non-betalactam products. Aurobindo now has a total of 208 ANDA approvals from USFDA, the company said.
