FDA grants permission to Mfr Amphotericin B to these Companies

We have issued as many as 19 licences since May 2021 to various companies to manufacture amphotericin B in the form of both liposomal and emulsion injections-FDA

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FDA

Last Updated on August 4, 2021 by The Health Master

The Gujarat Food and Drug Control Administration (FDCA) has granted approval to various pharmaceutical companies to manufacture amphotericin B injection, an antifungal medication used for serious fungal infections including mucormycosis and leishmaniasis.

“The pharmaceutical companies which started production include Emcure Pharmaceuticals (Ahmedabad), Lyka Labs (Anleshwar), Gufic Biosciences (Navsari), Sun Pharmaceuticals (Halol), Alembic Pharmaceuticals (Karkhadi), Intas Pharmaceuticals (Matoda), BDR Pharmaceuticals (Vanseti), Rusan Pharma (Gandhidham), Sumar Biotech (Gojhariya), Swiss Parentals (Bavla), Punishka Healthcare (Pipan), Bharat Parentals (Vadodara),” stated Gujarat FDCA Commissioner Dr H G Koshia.

Dr H G Koshia added, “We have issued as many as 19 licences since May 2021 to various companies to manufacture amphotericin B in the form of both liposomal and emulsion injections.”

Amphotericin B is an antifungal medication used for serious fungal infections and leishmaniasis. The fungal infections it is used to treat include mucormycosis, aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, and cryptococcosis. For certain infections, it is given with flucytosine. It is typically given by injection into a vein.

Medicine Injection
Picture: Pixabay

Mucormycosis, also known as black fungus, is a serious fungal infection, usually in people with reduced ability to fight infections. Symptoms depend on where in the body the infection occurs. It most commonly infects the nose, sinuses, eye and brain resulting in a runny nose, one sided facial swelling and pain, headache, fever, blurred vision, swollen and bulging eye, and tissue death. Other forms of disease may infect the lungs, stomach and intestines, and skin.

Gujarat is the largest manufacturer of API amphotericin in India.

Earlier, Gujarat FDCA has given approval to seven more units to manufacture remdesivir injection. This includes units of Cadila Healthcare Limited and Lincoln Pharmaceuticals. Gujarat currently has 14 units which are manufacturing remdesivir. This will take total number of remdesivir manufacturing units to 21, stated Dr H G Koshia.

The units under Cadila Healthcare Ltd include the facilities of Amneal Pharmaceuticals, German Remedies, Gufi Biosciences Ltd, Elsiyum Pharmaceuticals, Abaris Pharmaceuticals.

Gujarat FDCA makes optimum use of information technology for achieving excellence in performance. FDCA, Gujarat is the first State to initiate online software for sales and manufacturing licenses.

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