Biocon submits CAPA plan for Bevacizumab

The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan). The CRL informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022. The company has submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and are confident of addressing the observations within the stipulated time frame. The CRL did not identify any outstanding scientific issues with the dossier.

Laurus Labs updates on inspection at formulations aacility

Laurus Labs Limited has announced that the United States Food & Drug Administration (USFDA) completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh. The inspection was conducted from 6th February, 2023 to 10th February, 2023. We have been issued a Form 483 with two observations. The observations are procedural in nature. The Company will address the observations within stipulated timelines.

Smruthi Organics’ API site completes inspection by South Korean regulator

Smruthi Organics Ltd's flagship API site has been successfully inspected by Ministry of Food and Drug Safety (MFDS), Republic of South Korea leading to the registration of its product in the Korean market. This positive outcome will enable the company to export its products to Republic of South Korea and several other signatory countries of the PIC/S scheme.