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PRE APPROVAL INSPECTION
What challenges could stand in the way of a final US-Iran deal?US-Iran war news: High-stakes talks between the U.S. and Iran begin in Switzerland. Negotiators face major challenges including Iran's nucl...- Trump Iran deal: Strait of Hormuz, Israel, lack of nuclear trust - list of ways talks could falterIran deal with Donald Trump's U. S is the most keenly watched global event this week along with FIFA Football World Cup 2026.
- When environmental rules stall housing, not pollutionIndia's environmental clearance process often delays urban housing projects, raising costs and slowing jobs without improving protection. A...
- ET Prime Special Series: Multibagger or IBC - Part 59: Japan taught it. Tata bought it. Now EVs will test this auto ancillaryThis is a story about a company that is simultaneously an asset and an anomaly. An asset because it builds a tangible, necessary product, g...
- UPS Flight 2976 Louisville crash new CCTV footage reveals final moments before aircraft engine catches fire as NTSB examines engine separation and safety failuresUPS Flight 2976 Louisville crash new CCTV footage reveals final moments before aircraft engine catches fire after investigators released su...
- 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.
- Planning a Bali trip? Visa on Arrival rules for Indian travellers explainedIndian travellers planning trips to Bali and Indonesia can now utilize the Visa on Arrival facility. This allows for short stays of up to 3...
- State-owned AIESL eyes more international biz, enhanced servicing capabilities at its Nagpur MRO facilityAIESL, a state-owned MRO provider, is expanding its Nagpur facility. The company seeks to serve more international airlines and is pursuing...
- DPIIT rolls out multi-sectoral regulatory relaxations to bolster industrial supply chainsThe Department for Promotion of Industry and Internal Trade is ensuring continuous supply of fuel, gas, and essential raw materials. Measur...
- Faster insolvency process proposed with creditor-led resolution frameworkA new Creditor-initiated Insolvency Resolution Process (CIIRP) aims to expedite debt resolution, allowing financial creditors with 51% debt...
- USFDA issues Form 483 with five observations to Torrent Pharma unitTorrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspectin...
- Stelis Biopharma receives establishment inspection report from USFDAThis follows the abbreviated quality system inspection technique drug pre-approval on-site inspection specifically conducted by the US Food...
- USFDA issues Form-483 with 3 observations to Alkem Lab's St Louis plant"There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall subm...
- USFDA issues 3 minor observations to Granules India arm in pre-approval inspectionCommenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor obse...
- Natco Pharma gets EIR from USFDA for Telangana facilityThe United States Food and Drug Administration (USFDA) had conducted pre-approval inspection at the company's drug formulations facility in...
- Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observationsBiocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with...
- Biocon slips over 2% on 6 USFDA observationsUS health regulator issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility ...
- USFDA conducts inspection of Sun Pharma’s Halol site: SourcesThe USFDA inspection at Halol in 2015 had resulted in 23 observations – a set of deficiencies in the manufacturing processes.
- Biocon plunges 4% as French regulator decides to re-inspect facilityThe re-inspection will be to verify implementation of the proposed corrective and preventive actions, the company said.
- ANSM gives GMP nod to Biocon, to re-inspect drug product unitBiocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow- up inspection of t...
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