News about Quality / GMP

CDSCO directs API manufacturers to file online applications for issuance of WC certificate on new SUGAM portal

CDSCO directs API manufacturers to file online applications for issuance of WC certificate on new SUGAM portal

The Central Drugs Standard Control Organisation (CDSCO) has directed active pharmaceutical ingredient (API) manufacturers to file online applications for issuance of written confirmation certificate (WCC) on the new SUGAM module. For exporting APIs to European Union (EU) countries, a written confirmation certificate is must

Quality / GMP | 09/07/2021 | By Darshana 2242

Lupin's Nagpur Facility Receives EIR from U.S. FDA

Lupin's Nagpur Facility Receives EIR from U.S. FDA

Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U.S. FDA inspection of its Nagpur, India facility. The inspection for the facility was carried out by the U.S. FDA between January 6, 2020 and January 10, 2020

Quality / GMP | 13/04/2020 | By Darshana 1061

 
 

 

 

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