USFDA
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Franchise India Bureau Mar 26 2018 - 1 min readDrug firm Zydus Cadila has received the final nod from US health regulator to market Metoprolol Succinate extended-release tablets, used for treatment of various cardiac conditions, in the American market. The product will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said in a statement.
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Franchise India Bureau Mar 22 2018 - 1 min readSun Pharma has received a US Food and Drug Administration approval for its novel psoriasis drug TildraKizumab, the first new drug approval for India’s largest drug maker. The drug, which will be sold under brand name Ilumya, is expected to treat adults with moderate-to-severe plaque psoriasis, an auto immune disease. Illumya ...
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Franchise India Bureau Mar 19 2018 - 1 min readDrug major Lupin has received approval from the US health regulator to market Desoximetasone Topical spray, a formulation for treatment of plaque psoriasis, in the American market. It is a generic version of Taro Pharmaceuticals USA Inc.'s Topicort Topical Spray, 0.25%. The approval has been granted to the product ...
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Franchise India Bureau Mar 17 2018 - 1 min readDrug major Dr Reddy's Laboratories has claimed to have received four observations from US health regulator after inspecting its active pharmaceutical ingredients (API) facility in Telangana. Dr Reddy's in a regulatory filing said, "The audit of our API Hyderabad plant 1 at Jinnaram Mandal, Medak district, Telangana, by the USFDA has ...
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Franchise India Bureau Mar 15 2018 - 1 min readStrides Shasun has claimed to have received approval from the US health regulator for its generic Efavirenz tablet used for treatment of HIV Type-1 infected adults and adolescents. The company in a regulatory filing said, “The approval granted to the company's wholly-owned subsidiary Strides Pharma Global Pte by the US Food ...