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GMP INSPECTION
Regulators tighten GMP oversight of pharma plantsSeveral states have constituted dedicated multi-member teams to ensure no facility slips through the cracks before a GMP Certificate is iss...- Over 60% of pharma MSMEs yet to comply with updated manufacturing normsPharma industry officials say the revised Schedule M regulations could require Rs 10-15 crore per facility in upgrades, while talent shorta...
- Zydus Biologics’ Ahmedabad injectable facility gets 7 observations in USFDA inspectionZydus Lifesciences has made headlines as its Zydus Biologics injectable plant in Ahmedabad underwent a USFDA inspection between April 27 an...
- 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.
- 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 (...
- No observations by US FDA during plant inspection: DRLDr. Reddy's Laboratories announced that the U.S. Food & Drug Administration (FDA) completed a routine Good Manufacturing Practice (GMP) ins...
- Biocon Biologics gets EMA nod to produce biosimilar Bevacizumab at Bengaluru plantBiocon Biologics received EMA approval to manufacture biosimilar Bevacizumab in Bengaluru, providing additional capacity to address patient...
- Biocon gets 4 observations from USFDA for Andhra Pradesh facilityBiocon received four observations from the US health regulator after a GMP inspection at its API facility in Andhra Pradesh.
- 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...
- 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 ...
- Dr Reddy's clears USFDA inspection for two plantsDr Reddy's said it has received establishment inspection report (EIR) for its formulations manufacturing unit in Srikakulam (FTO SEZ PU2), ...
- Cipla's Pithampur unit gets 8 observations from USFDA after inspectionThe US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facilit...
- Strides Pharma Science's Puducherry facility successfully completes EU GMP inspectionThe inspection was carried out on April 28, 2021 and the company has now received the renewed GMP (Good Manufacturing Practices) certificat...
- Biocon gets EIR from USFDA for manufacturing facility in BengaluruBiocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good man...
- USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facilityAs per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditi...
- UK regulator reinstates full GMP status of Indoco Remedies Goa facilityWith this development, the company's operations in Europe will now take off on a fast-track, Indoco Remedies MD Aditi Panandikar said.
- Sun Pharma gets 3 observations from USFDA for Halol plantThe United States Food and Drug Administration (USFDA) conducted the Good Manufacturing Practices (GMP) inspection of the company's Halol f...
- 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...
- Wockhardt's Chikalthana plant gets GMP certificate from UKMHRAIn a major relief to drug firm Wockhardt, its Chikalthana plant at Aurangabad in Maharashtra has received a good manufacturing practice cer...
- EU lifts drug export ban from Ranbaxy's Toansa plantThe assessment of the Toansa facility by EMA followed an inspection by the USFDA, which revealed areas of non-compliance with GMP at the si...
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