Centaur Pharma Ambernath facility receives EIR from USFDA Farhat Nasim28 Nov 2019 4:00 AM GMTCentaur 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 6:43 AM GMTThe 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 4:15 AM GMTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for...
IOL Chemicals and Pharma Ibuprofen manufacturing facilities in Barnala clears USFDA inspection Medical Dialogues Bureau30 Oct 2019 8:41 AM GMTMumbai: IOL Chemicals and Pharmaceuticals (IOLCP) recently received a communication from US Food and Drug Administration (USFDA) with respect to an...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 4:30 AM GMTThe 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 Bioeguivalcnce Center at Taloja clears USFDA inspection Medical Dialogues Bureau28 Oct 2019 4:30 AM GMT"This is to inform that the US FDA had conducted an inspection at Alkem Laboratories Ltd's Bioequivalence Center located at Taloja, Maharashtra from...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 6:16 AM GMT"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Cadila Healthcare largest API manufacturing site clears USFDA inspection Medical Dialogues Bureau12 Oct 2019 6:11 AM GMTThe US Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from...
Aurobindo Pharma Unit-7 gets 7 USFDA observations Medical Dialogues Bureau8 Oct 2019 9:24 AM GMTThe United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company's unit-7...
Natco Pharma Mekaguda facility gets EIR from USFDA Farhat Nasim1 Oct 2019 10:27 AM GMTHyderabad: Drug firm Natco Pharma today said it has received Establishment Inspection Report (EIR) from the US health regulator for its Active...
Cipla gets 12 USFDA observations for Goa facility Medical Dialogues Bureau30 Sep 2019 9:45 AM GMT"The United States Food and Drug Administration (USFDA) conducted a cGMP inspection at our Goa manufacturing facility from September 16-27, 2019,"...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sep 2019 4:45 AM GMT"At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the...
