After Genetek, FDA wants more cos to make Amphotericin B

Nagpur: The Food and Drugs Administration (FDA), Nagpur, which has given nod to Genetek Lifesciences Private Limited in Wardha to manufacture Amphotericin B, wants more pharmaceutical companies to follow suit.
Genetek, now waiting for ingredients to arrive from abroad, would manufacture Amphotericin B Emulsion which is expected to hit the markets in another three weeks’ time. Costing barely 25% of liposomal Amphotericin B, Genetek’s Ampho emulsion would have a price tag of around Rs1,200, said its managing director Mahendra Kshirsagar.
The FDA is facing an uphill task after three crucial anti-fungal drugs of Amphotericin family (liposomal, deoxycholate and emulsion) went out of stock in the backdrop of a sudden spike in mucormycosis cases. It has started approaching the pharmaceutical companies to explore whether they have adequate capacities to manufacture the anti-fungal drug.
With only one company in Maharashtra is so far manufacturing the drug, FDA and district administration were left a helpless lot after the black fungus infection started affecting Covid recovered patients in large numbers. “The only company which manufactured Amphotericin B in Maharashtra has started increasing its production. The product had never seen such demand in the past as it is experiencing now,” said an FDA official.
“There are around half a dozen pharmaceutical companies in Vidarbha who can manufacture the drug. We are approaching them,” he said and added, “Genetek’s production will take some load off the demand but the approval has been granted just now.”
Khirsagar said Ampho emulsion is much safer than deoxycholate (also known as conventional Ampho) and its toxicity is minimum. “Deoxycholate has become redundant. Its safer to use Emulsion which is also cheaper than liposomal variety,” he said and added, “We also have the capacity to manufacture even liposomal, but it’s very costly.”