Five pharmaceutical companies get permission from the Indian regulator to produce anti-black fungus drugs

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Drugs Controller General of India (DCGI) has approved applications by five pharmaceutical companies for the production of the antifungal drug amphotericin B for the treatment of mucormicosis or black fungus, First Word Pharma reports.

The Committee of Subject Matter Experts (SEC) of the Ministry of Health of India approved proposals by companies to increase the availability of amphotericin B. The need for the drug increased amid the rapid spread of the disease in several states of India at once. In total, more than 5,500 cases of mucormicosis were recorded in the country.

The drug is currently supplied by Abbott, Bharat Serums, Cipla, Sun Pharma and Viatris. Several pharmaceutical companies, including Alembic, Emcure and Natco, have requested permission to manufacture it.

The chief financial officer of Alembic Pharmaceuticals said the company is also discussing shipments of active pharmaceutical ingredients (APIs) and packaging materials with third-party manufacturers.

“We increased Lambin B production for injections (liposomal amphotericin B) to meet additional demand,” Sun Pharma said.

“Viatris and Gilead are working closely with the government to accelerate AmBisome deliveries to help meet the growing needs of patients in India,” said Rakesh Bamzai, head of Viatris in India.

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