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USFDA COMPLIANCE
Sun Pharma: How a small Kolkata trader became a global buyout artistSun Pharma, led by Dilip Shanghvi, is poised for its largest overseas acquisition, a $12.5 billion deal for Organon & Co. This move continu...- Hyderabad Police Bust $250 mln cyber-intimidation racket targeting drug maker Hetero GroupHyderabad police have uncovered a sophisticated cyber-intimidation scheme. Perpetrators demanded a massive ransom from a Hetero Group emplo...
- Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA actionSun Pharma focuses on compliance across its manufacturing units. It aims for full regulatory resolution at facilities facing USFDA action. ...
- Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilitiesSyngene International shares:The initial update concerns a Good Clinical Practices (GCP) compliance inspection carried out at Syngene’s Sem...
- Indoco Remedies gets warning letter from USFDA for Goa plantIndoco Remedies' Goa plant received a warning letter from the USFDA following a July inspection. The company stated its commitment to resol...
- USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plantThe US Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, cit...
- 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 ...
- 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...
- Aurobindo Pharma receives warning from SEBI for non-disclosures related to USFDA auditThe market regulator, in its letter to Aurobindo Pharma dated June 24, said the company had disclosed very limited and restricted informati...
- Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA auditThe Sebi letter sent to the company on June 24, 2022 pertains to disclosures made by APL related to Official Action Indicated (OAI) and war...
- Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA auditThe letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by...
- Pharma stock that Jhunjhunwala exited in Q2 is now buzzing. Here's what analysts sayAce investor Rakesh Jhunjhunwala probably exited this counter in the second quarter, as his name was not among the shareholders holding ove...
- Indian pharma back in favour on improving fundamentalsAfter peaking in 2015, Indian pharma stocks are back in favour due to improved fundamentals of the companies.
- Patanjali says in “complete compliance of laws”; denies receiving notice from USFDAMedia reports earlier this week said labels on Patanjali's two sharbat products, earmarked to be sold within India, were found to be having...
- Biocon tumbles 9% as USFDA issues 10 observationsThe FDA inspection took place on May 25, June 1 and June 3.
- USFDA issues warning letter to Wockhardt's Ankleshwar plantUSFDA has already banned import of products from the facility into the US market since August 5, 2016.
- Awaiting USFDA response on remediation efforts of 3 units: Dr Reddys Laboratories"As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee told analysts.
- US court refuses Ranbaxy appeal to block ANDA nod for 2 drugsRanbaxy Laboratories had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the US market.
- 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.
- USFDA increases inspections of drug facilities in IndiaUSFDA is increasing its inspections of facilities of drug makers in India to ensure compliance of approved manufacturing norms.
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