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FDA PHARMACEUTICAL REGULATIONS
Alembic Pharma gets tentative nod from USFDA for generic cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Binimetinib tablets. This marks a significant step fo...- Govt outlines next phase of pharma growthThe government highlighted its achievements, reforms, and policy initiatives, aiming to boost exports from $31 billion to $50 billion by 20...
- More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
- India-New Zealand FTA to be signed on Monday, says PM Christopher LuxonIndia and New Zealand will sign a Free Trade Agreement on Monday, April 27. This landmark deal aims to boost bilateral trade significantly....
- Over 67,000 cases of deodorants sold at Walmart, Amazon recalled due to 'cGMP deviations'. What is it?Over 67,000 cases of Power Stick deodorant sold at major retailers like Walmart, Amazon, and Dollar Tree have been voluntarily recalled. Th...
- Two Indian CROs under lens as United States raises data integrity issuesUSFDA's action follows inspections at the facilities of Ahmedabad-based Synchron and Navi Mumbai-based Panexcell, as well as its own analys...
- US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
- Fleming Lab's Nawabpet facility comes under USFDA scannerEstablished in 1995, Fleming Laboratories is in the business of manufacturing and supply of generic Active Pharmaceutical Ingredients (APIs...
- Pharma’s stumble after six-year run may offer value buysWith four sessions remaining for the year to end, the Nifty Pharma index is down 17.3% so far in 2016, compared to the Nifty which is down ...
- Wanbury export issue shows regulator miscommunicationThe Maharashtra Food and Drug Administration’s finding that Wanbury shipped to four countries batches of metformin hydrochloride produced b...
- Alembic Pharma receives EIR report from USFDAUSFDA releases a copy of the Establishment Inspection Report to the establishment that was the subject of an FDA or FDA-contracted inspecti...
- USFDA issues import alert against Emcure Pharma's Pune plantUS health regulator has issued an import alert against Pune-based Emcure Pharmaceuticals for products made at its plant in Hinjwadi, Pune.
- USFDA plans to shift to an incentive based from a penalty based auditsIt could also help such a company get more flexibility should it seek some 'manufacturing changes' even after a drug is approved.
- Indian pharma company in dock over fake medicines in GhanaIndian drugmakers continue to find themselves on the wrong side of global regulators, with the latest being Maharashtra-based Bliss GVS Pha...
- Indian companies among firms yet to pay annual facility fees to FDAFDA has named at least five Indian companies among 43 drugmakers that have failed to meet their annual facility fee payment obligations.
- US drug regulator issues warning letter to RPG Life SciencesUSFDA has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants ...
- 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...
- 'Pharma not the best sector to bet on amidst US FDA compliance issues'"The reality at present is that the pharma stocks are always subject to problems with US FDA regulations," says Sajiv Dhawan of JV Capital.
- USFDA warns Sun Pharma on plant problemsThe US health regulator has served a warning letter on the American unit of Mumbai-based drug major Sun Pharma for violating good manufactu...
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