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Writer's pictureSanjay Trivedi

Zydus receives approvals from the USFDA for Two tablets & Gel

Zydus Cadila has received the final approval from the USFDA to market Doxycycline Hyclate Delayed-Release Tablets USP (US RLD – Doryx®) in the strengths of 75 mg, 100 mg and 150 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. The group also received a tentative approval for Febuxostat Tablets (US RLD – Uloric), 40 mg and 80 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. It is used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout. It helps in decreasing symptoms of gout which include pain, swelling, redness, heat, soreness, and stiffness in certain joints.

Zydus Cadila has received the final approval from the USFDA to market Clindamycin Phosphate and Benzoyl Peroxide Gel, (US RLD – DUAC® Gel), 1.2%/5%. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. This combination medication is used to treat a certain type of acne (inflammatory acne vulgaris). It helps to decrease the number of acne pimples. Clindamycin is an antibiotic that stops the growth of acne-causing bacteria. Benzoyl peroxide can also stop the growth of bacteria as well as reduce oil production in the skin. The group now has 242 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.

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