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API PLANT INSPECTION
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- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbook
- USFDA issues Form 483 with 3 observations to Ipca's Tarapur plantAs per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any con...05 Dec, 2025, 03.41 PM IST
- Dr Reddy's gets 2 observations from USFDA for Telangana API plantDr. Reddy's Laboratories received a Form 483 with two observations following a GMP inspection by the USFDA at its API manufacturing plant (...25 May, 2025, 02.42 PM IST
- Emcure Pharma gets Form 483 with two observations for API plant from USFDAEmcure Pharmaceuticals received two observations from the USFDA after an inspection of its Pune API facility. The company is addressing the...26 Feb, 2025, 02.57 PM IST
- USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plantThe USFDA has issued a warning to Jagsonpal Pharmaceuticals following an inspection of its API plant in Rajasthan. The regulator highlighte...23 Feb, 2025, 03.17 PM IST
- Margin levels of our API to increase once we enter US biz: Amit Rajan, Bajaj HealthcareHowever, the pre-approved inspection has happened for one of the product where it will go to a big pharma para IV product and the supply wi...15 Sep, 2023, 12.43 PM IST
- Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-endUSFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at DR Reddy's API manufacturing...30 Jul, 2019, 02.06 PM IST
- Buy Aurobindo Pharma, target Rs 705: ICICI DirectAurobindo Pharma is a largecap company, operating in pharmaceuticals and health care sector.24 Jun, 2019, 03.29 PM IST
- Dr Reddy's gets EIR from USFDA for UK plantThe USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close th...24 Apr, 2018, 12.48 PM IST
- Dr Reddy's gets EIR from USFDA for Srikakulam plantDr Reddy's today said it has received the establishment inspection report (EIR) from the USFDA for its its formulations facility in Srikaku...25 Feb, 2018, 07.01 PM IST
- Dr Reddy's Labs jumps 3% on completion of USFDA audit at Srikakulam plantThe stock rose 3.04 per cent to hit a high of Rs 2,721.95 on BSE.17 Apr, 2017, 10.58 AM IST
- USFDA inspection was planned and company was informed in advance: Sucheth Rao Davuluri, Neuland LabsIn an exclusive chat with ET Now, Sucheth Rao Davuluri, VC & CEO, Neuland Labs, said that the firm has already started working on clearing ...11 Apr, 2017, 11.53 AM IST
- Sharon Bio-Medicine gets USFDA nod for API plant in TalojaThe inspection was conducted during June 29, 2015 to July 7, 2015 at the Taloja plant, it added.20 Sep, 2016, 02.23 PM IST
- Alkem's Mandva plant gets establishment nod from USFDAAlkem Labs Ltd today said one of its manufacturing plants in Gujarat has obtained the Establishment Inspection Report (EIR) "approval" from...07 Mar, 2016, 12.59 PM IST
- SeQuent unit gets establishment inspection report from USFDADrug firm SeQuent Scientific today said it has received a report from the US health regulator, indicating closure of inspection of its plan...10 Nov, 2015, 02.06 AM IST
- USFDA observations relate to quality control testing: Saumen Chakraborty, Dr Reddy's"There are some API sales which have been happening. We are just getting all the numbers right."06 Nov, 2015, 12.22 PM IST
- Drug Controller General of India to inspect bulk drug plants exporting to EUDCGI is readying a plan to check if domestic bulk drug facilities that export to the European Union comply with WHO-prescribed norms.20 Mar, 2013, 05.07 AM IST
- Drug cos eye US entry after FDA checksThe US drug regulator has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies...05 Jul, 2011, 02.58 AM IST
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