Centaur Pharma Ambernath facility receives EIR from USFDA Farhat Nasim28 Nov 2019 9:30 AM ISTCentaur Pharma has now received a formal EIR (Establishment Inspection Report) from USFDA stating the facility is CGMP compliant and the audit outcome...
Aurobindo Pharma gets 14 USFDA observations for Pashamylaram facility Farhat Nasim15 Nov 2019 12:13 PM ISTThe US Food and Drug Administration (USFDA) inspected company's Unit IV, a general injectable formulation manufacturing facility situated at...
Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations Medical Dialogues Bureau2 Nov 2019 9:45 AM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 10:00 AM ISTThe audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the...
Alkem Labs gets EIR from USFDA for St.Louis facility Medical Dialogues Bureau12 Sept 2019 9:30 AM IST"In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019,...
Alkem Labs gets 2 USFDA observations for Daman facility Medical Dialogues Bureau31 Aug 2019 12:32 PM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received two observations from the US health regulator for...
Alkem Labs gets 4 USFDA observations for St Louis facility Medical Dialogues Bureau26 Aug 2019 12:39 PM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received four observations from the US health regulator...
Dr Reddys gets 8 USFDA observations for Duvvada facility in Andhra Pradesh Medical Dialogues Bureau21 Aug 2019 10:00 AM ISTThe audit of Dr Reddy's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug...
Natco Pharma gets 6 USFDA observations for API facility near Hyderabad Medical Dialogues Bureau13 Aug 2019 1:16 PM ISTNatco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
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: 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...
