Last Updated on December 31, 2023 by The Health Master
New Delhi: Strides Pharma Science Ltd said it has received an establishment inspection report (EIR) from the US health regulator for its Puducherry manufacturing facility.
The US Food and Drug Administration issues an EIR on closure of inspection of an establishment that is the subject of an USFDA or USFDA-contracted scrutiny.
The US Food and Drug Administration (USFDA) has closed the inspection conducted between February 20-24, 2023 and has classified the facility from official action indicated (OAI) to voluntary action indicated (VAI), Strides Pharma Science said in a regulatory filing.
The company has received an EIR from the USFDA, it said. Earlier, the USFDA had classified Strides‘ Puducherry facility as OAI in May 2019, followed by issuing a warning letter to this site in July 2019.
The Puducherry facility caters to the US, other regulated markets, and institutional businesses and produces finished dosage formulation products across multiple dosage formats.
“Consequent to this reclassification by the USFDA, the filed abbreviated new drug applications (ANDAs) from this facility will now start receiving approvals,” the company said.
USFDA issues Form 483 with zero observations to Pharma MSMEs: Gujarat
USFDA issues Form 483 with 3 observation to Zydus, Ahmedabad
USFDA issues Form 483 with zero observation to Piramal
USFDA issues Form 483 with 10 observations to Lupin, Pithampur
USFDA issues Form 483 with 2 observations to Alembic, Gujarat
USFDA issues Form 483 with 3 observations to Bliss GVS Pharma, Maharashtra
NPPA fixed Ceiling price of 5 scheduled formulations: May 2023
NPPA revised Ceiling price of 15 scheduled formulations: May 2023
Pharma Industry seek price ceiling exemption for low cost drugs
One more arrest in Spurious Pharma Raw Material case
NPPA fixed retail price of 15 formulations: May 2023
Revising DT limit for Soft Gelatin Capsules: Pharma Industry seek solutions
Drug alert: 36 out of 895 samples declared as NSQ in April 2023
Revising DT limit for Soft Gelatin Capsules: Pharma Industry seek solutions
Govt to amend New Drugs and Clinical Trials Rules 2019 (NDCTR)
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
