The DCGI has instructed the CDSCO Zonal office Ahmedabad to conduct the inspection of BDR Pharmaceuticals’ formulation facility, Vadodara and submit the report within seven days. It is part of the Central Drugs Standard Control Organisation (CDSCO) measures to fast track applications for permission to manufacture and market remedisivir injections.
Earlier, this month, the company entered into a contract manufacturing agreement with Cipla for remedisivir. Reportedly, BDR Pharmaceuticals has manufactured the batches of remdesivir injection at its research and development centre, Halol and has already initiated stability testing.
BDR Pharmaceuticals has transferred the formulation technology and methods of development along with other technical inputs related to remdesivir to Sovereign Pharma under a license agreement signed by the companies nearly 10 days back.
The agreement was signed considering the lyophilised technology required for remdesivir injections and available capabilities with Sovereign Pharma. The latter is already involved in manufacturing products like low molecular weight hetarine along with a few anti-fungal drugs for BDR Pharma.
A source from Daman FDA informed, “On June 17, in a joint inspection by the Daman FDA team and officials of CDSCO West Zone Mumbai conducted the regulatory inspection at Sovereign Pharma’s formulations and development facility located at Daman, and the team received satisfactory data and response from the inspected facility. We (Daman FDA) have already submitted the collected data from the inspection site of Sovereign Pharma to the DCGI office, the company will get a revert soon.”
“Today, the deputy drug controller (India) CDSCO Zonal Office Ahmedabad along with the State FDA officers will be conducting the inspection of BDR Pharma’s formulation facility. This inspection is to verify product-related chemistry, manufacturing and control (CMC) data generated by the firm in the context of approval of the new drug,” informed the source from Daman FDA.
Sovereign Pharma, reportedly, has the capacity to manufacture 50,000 vials per month. After clearing the approval process to manufacture and market remdesivir injection in India, BDR Pharma is also planning to apply for exports.
Dharmesh Shah, CMD, BDR Pharmaceuticals refused to comment.