Shree Anand Life Sciences has received license from Karnataka state drugs controller to manufacture lypholised conventional Amphotericin B, which is used to treat deadly black fungus infection Mucormycosis that has affected patients during post COVID-19 recovery. The company is all set to produce 10,000 to 12,000 per capacity of this life-saving drug.
Now Belagavi-based Shree Anand Life Sciences has been granted the license for liposomal Amphotericin B and they are yet to start manufacture, said Karnataka drugs controller BT Khanapure.
The company confirmed that the drug license was granted to manufacture the much wanted lypholised conventional Amphotericin B injectable. “Our brand is Amposol. Trial production batches are on. We are gearing up to commence production of the final product early next week. Our production capacity will be 10,000 to 12,000 per cycle of 30 hours. Since it is a lypholised products 12,000 vials require 30 hours per cycle. We will be able to make the required supplies”, Satish M Gharge, chairman and managing director, Shree Anand Life Sciences told Pharmabiz.
The company is also known to manufacture several other critical care medicines used for COVID-19 emergency use. These injectables are Remdesivir, Ascorbic acid, Azithromycin, Dexamethosone, Doxycycline and Enoxaprin 40mg and 60 mg. Its advanced manufacturing unit at the Honga Industrial Area in Belagavi manufactures injectables in ampoules and vials. Besides it is also known for its production of dry powder parenterals and lyophilized prefills, Gharge added
India is facing an acute shortage of liposomal Amphotericin B which hospitals are clamoring to control the deadly black fungus infection: Mucormycosis that has affected patients during post COVID-19 recovery. Currently, this antifungal generic medication is the drug that is being prescribed across hospitals in the country. Karnataka has sought 25,000 vials of this drug from the Union government even as the country faces scarcity.
In Gujarat, 100 people succumbed to this disease, in Maharashtra too there has been a substantial number of fatalities. In Karnataka, 20 cases are reported across Raichuru, Mysuru, Kalaburagi, and Belagavi with their condition being serious.
Gilead is the innovator for Amphotericin B known for its brand AmBisome which is a sterile lyophilized injectable. There are only handful of companies in India engaged in the production of Amphotericin B. These are Mylan which is the largest producer but imports it for distribution in India. Other players are Sun Pharma with two brands: Lambin and Envocin ,Cipla’s Phsome Instas’ Amfy and Abbot’s Fungizone and Abyhope, Bharat Serums’ Amphonex, Ahaan Healthcare and Celon Labs. Now Shree Anand Life Sciences gets license to manufacture this drug.
Medical experts in ICUs from Mysuru, Bengaluru and Chamarajanagar said that Mucormycosis is an aggressive fungal infection and requires at least 30 to 80 vials of Amphotericin B per patient. This comes into patients who have been on steroids and the human system becomes immuno-compromised.
News Source : Nandita Vijay, Bengaluru | PharmaBiz.com