Indoco Remedies gets USFDA ANDA nod for Glycopyrrolate Injection Medical Dialogues Bureau3 Nov 2019 10:00 AM ISTGlycopyrrolate is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the...
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...
Indoco Remedies: USFDA retains OAI status for Goa plant Farhat Nasim25 April 2019 9:50 AM ISTIndoco Remedies' spokesperson said that the move is likely to withhold approval of pending abbreviated new drug applications (ANDAs) from Goa...
USFDA inspected Goa facility, no observations issued: Indoco Remedies Farhat Nasim30 March 2019 11:52 AM ISTThe US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of Indoco Remedies for finished dosages.New...
