Searched for
USFDA FLAGS
India bans 16 fixed-dose drug combinations over safety concernsIn a significant public health initiative, the ban on 16 fixed-dose drug combinations, including various antibiotics and topical formulatio...- Cipla shares slide 5% after temporary halt in key drug manufacturingCipla shares fell sharply on Friday after a halt in Lanreotide Injection production due to USFDA observations at its Greek partner. Supply ...
- USFDA flags Telangana unit of Aurobindo Pharma armThe letter, issued on August 15, was later made public by the USFDA, which stated that there was failure to ensure the accuracy of data in ...
- India to demand faster inspection of pharma firms by USFDA; raise export regulations at TPF on FridayThe Indian side will also raise the issue of reinstating the Generalized System of Preferences (GSP) status to India, the official said.
- US FDA issues import alert on Sun Pharma's Halol facilitySun Pharma on Thursday said the US Food and Drug Administration (USFDA) has imposed an import alert on its Halol manufacturing site in Guja...
- Cipla sticks to 21-22% operating profit guidance for FY23, posts Rs 789 crore profit in Q2Cipla reported a multi-quarter high of $179 million in revenue and 25% YoY growth led by the successful launch of a generic version of the ...
- Lupin gets warning letter from USFDA for Tarapur API plantDrug firm Lupin on Thursday said it has received a warning letter from the US health regulator for its Tarapur-based manufacturing facility...
- Pharma company Panacea Biotec gets warning letter from USFDA for Baddi facilityThe company will actively engage with the agency and take all necessary steps required to address the United States Food and Drug Administr...
- Aurobindo Pharma under USFDA scrutinyAurobindo has seen intense scrutiny on the manufacturer process of valsartan, an anti-hypertension drug, that was found to contain carcinog...
- USFDA red flags Torrent Pharma for violation of norms at Indrad facilityStating that company's investigations into testing results were inadequate, the letter said this is a repeat observation from USFDA's April...
- Aurobindo Pharma, Glenmark crack on USFDA observationsAurobindo Pharma plunged 19% after USFDA flagged lack of good manufacturing practices at the Telangana plant.
- USFDA red flags Lupin for significant violations at MP unitThe USFDA said it had inspected the Unit 1 at the Mandideep facility of the company from November 26 to December 4, 2018.
- 'Fat finger' trade sends Dr Reddy's down 10%This is the second time in this year that stock has seen a sharp drop.
- 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...
- USFDA issues warning letter to Megafine Pharma for Vapi plantSummarising significant deviations from CGMP norms at the Vapi unit, the US Food and Drug Administration said that its investigators observ...
- USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violationsAlthough the company committed to addressing issues identified with the water systems and cleaning validation, the overall response lacked ...
- We will certainly take a relook at our quality systems: Sandeep Singh, Alkem LaboratoriesThere is only one crirical observation has been made by UK MHRA against the company's QA process
- Indian Pharma: Regaining our brand equityThe perception that India-made drugs are of “bad quality” is largely due to many related and unrelated convergence of events.
- Ranbaxy slips as USFDA refuses request to allow exports from banned unitsThe USFDA prohibited Ranbaxy Labs from manufacturing and distributing APIs from its Toansa plant for FDA-regulated drug products.
- Now, drugmaker USV pulled up by USFDA for data fudgingAfter an inspection of USV's Mumbai lab, USFDA said the company's "drug product test method validation data is falsified", according to doc...
Load More
