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Zydus Cadila gets tentative approval from USFDA for Apremilast Tablets

Zydus Cadila has received the tentative approval from the US Food and Drug Administration (USFDA) to market Apremilast Tablets (US RLD— Otezla) 10 mg, 20 mg, and 30 mg. This medication is used to treat a certain type of arthritis (psoriatic arthritis) and a certain type of skin condition (moderate to severe plaque psoriasis). It is also used to treat mouth sores in people who have Behcet‘s disease, a type of inflammatory disorder and helps to reduce the pain and improve the healing of these mouth sores.

It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The group now has 276 approvals and has so far filed over 360 ANDAS since the commencement of the filing process in FY 2003-04.

Cadila Healthcare is an India-based pharmaceutical company. The company’s subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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