Searched for
CGMP QUALITY STANDARDS
USFDA warns Cipla for lapses in manufacturing practices at Pithampur facilityAccording to an exchange filing, the drug manufacturer was given a detailed breakdown of the lapses in methods followed at the facility by ...20 Nov, 2023, 08.30 AM IST- USFDA issues warning letter to Intas Pharma for Sanand plantIntas Pharmaceuticals has been criticised by the USFDA for multiple manufacturing faults, including deficiencies in its quality control sys...06 Aug, 2023, 11.25 AM IST
- Lupin gets warning letter from FDA for Tarapur facility, stock falls over 2%“We wish to inform you that the company has received a warning letter from the US FDA for the company’s Tarapur, Maharashtra facility. The ...29 Sep, 2022, 12.55 PM IST
- US FDA issues warning letter to Lupin's Tarapur unitThe United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin's Tarapur, Maharashtra facility, the company s...29 Sep, 2022, 10.39 AM IST
- USFDA issues warning to Shilpa Medicare for CGMP violations at Telangana plant"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutica...01 Nov, 2020, 11.57 AM IST
- Lupin gets 5 observations from USFDA for its Vizag facilityThe inspection of company's Vizag API manufacturing facility by the United States Food and Drug Administration (USFDA) has been completed, ...18 Jan, 2020, 03.17 PM IST
- USFDA issues warning letter to Lantech Pharma for manufacturing violations at Andhra plantIn a warning letter issued to the company's Managing Director V Prakash Reddy, the USFDA said inspectors during March 6-15 this year found ...29 Aug, 2019, 05.07 PM IST
- FDA pulls up Aurobindo Pharma for 'repeated' failures in CGMPThe FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.03 Jul, 2019, 06.33 PM IST
- Lupin gets EDQM nod for its Mandideep facilityThe inspection was focused on the application for certificate of suitability for the dossier of Cefaclor along with facility inspection for...30 Jul, 2018, 02.30 PM IST
- FDA warns Divi's Labs over data integrity issues at Vizag unitIt further said methods, facilities, or controls for manufacturing, processing, packing or holding at the facility did not conform to CGMP.27 Apr, 2017, 12.31 AM IST
- USFDA issues warning letter to USV Pvt over Daman plantThe warning letter to Managing Director Prashant K Tewari raised similar current good manufacturing practice (CGMP) violations at its other...23 Mar, 2017, 04.52 PM IST
- USFDA issues warning letter to ex-Sun Pharma US facilityThe Philadelphia plant is among the two facilities that Sun Pharma had sold to Frontida BioPharm in June this year, along with 15 products,...26 Aug, 2016, 06.31 PM IST
- USFDA issues warning letter to Megafine PharmaIt also pulled up the company for conducting "inadequate investigation of critical deviations or a failure of a batch to meet its specifica...01 Jun, 2016, 07.04 PM IST
- USFDA warns Sri Krishna Pharma for CGMP norm violationsThe US health regulator said its investigator "identified significant violations of current good manufacturing practice regulations for fin...20 Apr, 2016, 01.10 PM IST
- Cadila Healthcare plunges 17% on USFDA warning letterShares of Cadila Healthcare plunged 17 per cent on Thursday after the pharmaceutical company received two warning letters Moraiya formulati...31 Dec, 2015, 12.12 PM IST
- US FDA warns Dr Reddy's Laboratories of ban if flaws are not fixedUS FDA may also withhold approval of new applications from Dr Reddy’s if it fails to complete all corrections, it said in a letter dated No...26 Nov, 2015, 03.50 AM IST
- Mylan gets warning letter from USFDA for lapses at 3 unitsUSFDA has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice norms at its three plants in K...19 Aug, 2015, 09.09 PM IST
Load More
