Mucormycosis: Alembic gets Gujarat FDCA licence for anti-black fungal drug Amphotericin-B

Mucormycosis: Alembic gets Gujarat FDCA licence for anti-black fungal drug Amphotericin-B

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At present, Cipla, Sun Pharmaceuticals, Abbott India, Bharat Serums and Vaccines, and Celon Labs are manufacturing the drug.

Alembic Pharmaceuticals (APL) is all set to manufacture Amphotericin-B, a drug used to treat mucormycosis patients, after receiving a licence to do so from the Food & Drug Control Authority (FDCA), Gujarat.

“We have issued a licence to APL to make the anti-fungal drug at the company’s facility near Karakhadi village, around 40 km from its Vadodara headquarters,” said HC Koshia, Gujarat’s FDCA Commissioner.

Last week, Alembic and five other companies including Natco Pharma, Lyka Labs, Emcure Pharma, Gufic Biosciences and Protech Telelinks, received approval from the Drug Controller General of India’s expert panel to begin clinical trials for the drug.

“It would take at least a month to start manufacturing the anti-black fungal drug at our Karakhadi facility. We are acquiring necessary raw material and completing other formalities. Initially, the company is targeting 50,000 vials per month,” RK Baheti, director – finance & CFO of APL, said.

APL currently has six formulation and three API manufacturing facilities. Of the six formulation facilities, five are in and around Vadodara — three at Panelav and two at Karakhadi — while one is in Sikkim. Alembic currently manufactures general oral solids in Panelav and is setting up oncology oral solids and oncology injectable facilities at the same location. The company’s Karakhadi plants are equipped to manufacture injectable and ophthalmic products. APL is the flagship company of the over 100-year-old Alembic Group.

Liposomal Amphotericin-B injections are in huge demand due to a sudden surge in black fungus cases. Currently, the drug is in short supply. At present, Cipla, Sun Pharmaceuticals, Abbott India, Bharat Serums and Vaccines, and Celon Labs are manufacturing the drug.

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