Gujarat FDCA Approves Seven More Units To Manufacture Remdesivir

Gujarat FDCA Approves Seven More Units To Manufacture Remdesivir

By, Admin 30 July 2021

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!