Searched for
INSPECTIONS OF PHARMA UNITS
Delhi CM Rekha Gupta directs district administration to inspect Shalimar Bagh's Fortis HospitalFortis Hospital inspection: Delhi Chief Minister Rekha Gupta has ordered an immediate inspection of Shalimar Bagh's Fortis Hospital followi...- Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
- 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...
- 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...
- Tata-backed MedTherapy claims CAR-T breakthrough with one-day productionTata Sons-backed biotech startup MedTherapy said it has developed a next-generation CAR-T cell therapy manufacturing platform that can redu...
- Long-term Investing: Ecosystem with an edge called India; 12 large- mid- and small-cap stocks with upside potential of up to 34%Tactical investing should not be confused with long-term investing. In a world where geopolitical risk, commodity shocks, and uncertainty a...
- 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.
- Strides Pharma's Chestnut Ridge unit in New York classified as voluntary action indicated by USFDAStrides Pharma Science announced its US subsidiary, Strides Pharma Inc, has received a Voluntary Action Indicated classification from the U...
- Drug regulator for strict compliance with new Schedule MThe state drug regulators have been asked to submit monthly reports to the Central Drugs Standard Control Organisation on the inspections a...
- Natco Pharma's Kothur unit classified as 'voluntary action indicated' by US regulatorNatco Pharma Ltd announced that its Kothur unit in Hyderabad received an Establishment Inspection Report (EIR) from the US FDA, classifying...
- Govt steps up inspections at pharma units to ensure qualityGovernment authorities have conducted risk-based inspections at over 500 pharmaceutical manufacturing units since 2022 to enhance the quali...
- Indian pharma compliance standards improving, regulatory risks here to stay: Ind-RaAs Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...
- Aurobindo Pharma gets VAI classification from USFDA for Hyderabad unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- USFDA in active mode, issues obersvations to 4 drug makers in 3 days!SMS Pharma today informed exchanges that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at Kandivalasa,...
- Aurobindo Pharma gets 8 observations for 2 plants from USFDAThe company will be responding to the USFDA as per the prescribed time lines, the drug firm said.
- Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDAThe FDA conducted a cGMP (Current Good Manufacturing Practices) inspection at the Unit 7 manufacturing facility from September 19-27 this y...
- Good news for Sun Pharma, bad news for Aurobindo: Amit Rajan, Prosfora Tech“India still has to do a lot of things, the FDA’s expectations are increasing day by day.”
- If Sun Pharma inspections come through, 2018 could be a turning point for Indian pharma: Amit Rajan, Prosfora Technology“We have to get our things in order for sterile manufacturing and Sun Pharma Halol plant is mostly on steriles.”
- Orchid Pharma gets EIR from USFDA for its Chennai facilityAs per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings.
- USFDA completes inspection of Dahej unit: Ajanta PharmaForm 483 is issued to a company's management after completion of inspection of its facility to notify regarding objectionable conditions.
Load More
