Alembic Pharmaceuticals passes ANVISA, Brazil GMP audit for its API-II Facility at Panelav

Alembic Pharmaceuticals Limited has successfully completed the Brazilian Health Regulatory Agency (ANVISA) GMP audit at API-II Facility at Panelav for its 8 APIs. The inspection was conducted from 16th September, 2024 to 20th September, 2024.

Veerhealth Care receives closure of assessment from USFDA

Veerhealth Care Limited had received request from USFDA on 04/09/2024 about submission of required documentation against FDA Form 4003, which was being requested under section 704 of the Federal Food, Drug and Cosmetic Act. The company had submitted all the required data to USFDA on 18/09/2024. Upon submission of the required documentation, USFDA has issued FDA Form 4003a Records Receipt Confirmation and has confirmed that there are no further requests at this time, and have closed their RRA assessment.

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market.