Search result for 'form 483'

Aurobindo Pharma received a Form 483 with 11 observations from the USFDA for its Raleigh plant in North Carolina. The company plans to address the procedural observations.

Emcure Pharmaceuticals received two observations from the USFDA after an inspection of its Pune-based API manufacturing facility. The company is addressing the observations and will respond to the...

Glenmark Pharmaceuticals reported a consolidated profit after tax of Rs 348 crore in Q3 FY25, driven by strong regional performance. The company also announced a USFDA inspection at its Indore...

Dr Reddy's Laboratories received seven observations from the USFDA following an inspection of its Bollaram facility. The company will address the observations within the stipulated timeline.

Torrent Pharmaceuticals received a Form 483 with one observation from the USFDA after an inspection of its Pithampur manufacturing facility. The observation is procedural in nature and the company...

Dr Reddy's Laboratories received a Voluntary Action Indicated (VAI) establishment inspection report (EIR) from the USFDA for its API facility in Srikakulam, Andhra Pradesh.

Biocon received four observations from the USFDA after an inspection of its API facility in Visakhapatnam, Andhra Pradesh. The company will address the observations within the stipulated time.

Torrent Pharmaceuticals received a Form 483 with five observations from the USFDA after an inspection of its Gujarat manufacturing plant. The company will respond to the observations within the...

Cipla Ltd received a Form 483 from the USFDA for its Kurkumbh facility in Maharashtra, citing one inspectional observation. The company is committed to addressing the observation.

Marksans Pharma Ltd received five inspectional observations in Form 483 from the USFDA after an inspection of its Goa manufacturing facility. The company will address the observations within the...

Natco Pharma received a warning letter from the USFDA for its Telangana plant due to violations found during an inspection. The company assures minimal impact on supplies and revenues but...

USFDA issued Form 483 with 5 procedural observations to Torrent Pharma's Gujarat oral manufacturing facility. The observations were not related to data integrity.

Dr Reddy's Laboratories stock closed 5% lower after the USFDA issued three observations for its Hyderabad research facility. The company said it will address the issues within the stipulated timeline.