New Delhi: Five pharmaceutical companies have got the go-ahead to manufacture the anti-fungal drug Amphotericin B, used to treat mucormycosis or black fungus. The Drugs Controller General of India (DCGI) has cleared their applications.
The subject expert committee (SEC) of the health ministry had given its nod to proposals from drugmakers to boost the availability of Amphotericin B, Business Standard reported.
Amphotericin B, an injection, is currently sold by Abbott, Bharat Serums, Cipla, Sun Pharma and Viatris. Drugmakers, including Alembic, Emcure and Natco had sought nod to manufacture the drug.
“Amphotericin B injection is manufactured using liposomal technology. The production cycle of this injection is 25-28 days. Sterility tests need to be carried out and then only can the finished product be sent for distribution. While existing manufacturers are ramping up their production, new approvals will increase availability further. The Central Drugs Standard Control Organisation is fast-tracking the processes of all the drugs used for Covid-19 to ensure adequate supplies,” Business Standard quoted a pharma industry expert as saying.
R K Baheti, chief financial officer (CFO) of Alembic Pharmaceuticals, confirmed the SEC nod and said the company is now coordinating with third-party manufacturers for the supply of active pharmaceutical ingredients and packaging materials, among other things. Baheti, however, refused to divulge any timeline for production and supply of the injectable, the report added,
“We have ramped up production of Lambin B injection (Liposomal Amphotericin B) to meet the additional demand. We are confident of increasing our production rapidly because of the use of advanced technology in manufacturing,” Sun Pharma was quoted as saying.
Minister of State for Chemicals and Fertilisers, Mansukh Mandaviya, on Thursday, said the fresh approvals along with the ramp-up of production by existing six manufacturers and imports will help to end the shortage of the drug soon.
“As a leading health care firm, we are committed to doing our part to support the public health needs amid the Covid-19 pandemic. Viatris and Gilead are closely working with the government to accelerate supplies of AmBisome to help meet the evolving patient needs in India,” Rakesh Bamzai, president, India, emerging Asia and access markets, Viatris was quoted as saying.