Granules India completes USFDA inspection for Bonthapally facility with one observation Farhat Nasim29 July 2019 10:00 AM ISTGranules India Ltd's Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plant by volume. New Delhi: Drug...
Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa Medical Dialogues Bureau27 July 2019 9:45 AM ISTThe inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.NEW...
Indoco Remedies gets USFDA warning letter for significant violations at Goa facility Medical Dialogues Bureau26 July 2019 9:30 AM ISTStating the specific violations, the US Food and Drug Administration (USFDA) said Indoco Remedies failed to prepare batch production and control...
USFDA completes inspection at Laurus Labs' AP unit Medical Dialogues Bureau19 July 2019 10:02 AM ISTMumbai: Laurus labs recently announced that they have completed the US Food and Drug Administration (USFDA) inspection of Unit 4 at Visakhapatnam,...
USFDA issues warning letter to Indoco Remedies for Goa plant Medical Dialogues Bureau16 July 2019 11:39 AM ISTThe facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these...
Alembic Pharma clears USFDA inspection at oncology unit in Panelav Farhat Nasim29 Jun 2019 10:02 AM ISTThis was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.New Delhi: Alembic Pharmaceuticals...
Cipla gets no USFDA observations for Indore facility Farhat Nasim18 May 2019 9:45 AM ISTThe US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019. New Delhi: Drug firm Cipla...
