Instant Report

Date: 30-Jul-2021

Gujarat FDCA Approves Seven More Units To Manufacture Remdesivir

The Gujarat Food and Drug Control Administration (FDCA) has given approval to seven more units to manufacture remdesivir injection.

"This includes units of Cadila Healthcare Limited and Lincoln Pharmaceuticals. Gujarat currently has 14 units which are manufacturing remdesivir. This will take total number of remdesivir manufacturing units to 21,” stated Gujarat FDCA Commissioner Dr H G Koshia.

The units under Cadila Healthcare Ltd include the facilities of Amneal Pharmaceuticals, German Remedies, Gufi Biosciences Ltd, Elsiyum Pharmaceuticals, and Abaris Pharmaceuticals.

The existing manufacturing units includes Cadila Healthcare Ltd’s facilities at Changodar, Ahmedabad (one each in powder and liquid form), BDR Lifesciences, Cadila Healthcare Vatva, Ahmedabad, Cadila Healthcare Ankleshwar, Cipla Ltd, Hetero Labs, Syngene International, BDR Pharmaceuticals, BDR Lifesciences, Lyka Labs, and Bharat Parentals.

Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. During the Covid-19 pandemic, remdesivir was approved or authorized for emergency use to treat Covid-19 in around 50 countries.

The manufacturing units  has been prepared for the expected third wave of Covid-19 infections.

The government on June 14, 2021 amended the export policy for injection remdesivir under restricted category. Earlier, the government banned export of remdesivir injection on April 11, 2021 during the second wave of Covid-19 infection.

Based on Drugs Controller General of India (DCGI)’s No Objection Certificate (NOC), these seven manufacturing  licences are approved.

Remdesivir was originally developed to treat hepatitis C, and was subsequently investigated for Ebola virus disease and Marburg virus infections before being studied as a post-infection treatment for Covid-19.

Gujarat FDCA makes optimum use of information technology for achieving excellence in performance. FDCA, Gujarat is the first state to initiate online software for sales and manufacturing licenses.