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BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
Veeda Clinical Research refiles DRHP for IPO with SebiVeeda Clinical Research: Veeda Clinical Research has refiled its IPO papers with SEBI, planning to raise funds through a fresh issue and of...03 Feb, 2025, 06.05 PM IST- Veeda Clinical Research refiles DRHP with SEBICX Partners backed Veeda Clinical Research, a full-service contract research organization (CRO) has refiled its Draft Red Herring Prospectu...03 Feb, 2025, 05.41 PM IST
- Health Ministry moots Centre or state bodies be empowered to regulate drugs, cosmetics manufactureIndia's Health Ministry has mooted that either the Centre or state authorities be empowered to regulate the manufacture of drugs and cosmet...19 Jul, 2023, 02.25 PM IST
- Centre should regulate manufacturing of drugs instead of state bodies, new bill mootsFurther, the provision of taking permission to operate an e-pharmacy has been removed and replaced with the words -- central government may...12 Mar, 2023, 02.17 PM IST
- Optimus too could launch Covid pill Paxlovid soonThe company has conducted bioavailability and bioequivalence (BA/BE) studies and is likely to submit the safety data to the drug regulator ...26 Apr, 2022, 12.51 AM IST
- Nod for Paxlovid's Indian generic version to take longerHetero Labs and Optimus Pharma had approached the drug regulatory authority last month seeking waivers from conducting local trials. Howeve...19 Feb, 2022, 12.39 AM IST
- SEC no to clinical trial waiver for Pfizer's Covid pillThe SEC asked the companies to conduct bioavailability and bioequivalence (BA/BE) studies and submit safety data at its meeting on Friday, ...25 Jan, 2022, 05.59 AM IST
- Pharma majors knock at Niti Aayog's doors with concerns over new drug policyDrug companies have also objected to mandatory quality control BA/BE tests for all drugs, including for future renewals of manufacturing li...25 Sep, 2017, 11.50 PM IST
- Cipla’s inhalable insulin fails to get approval for trials on Indian patientsCipla had based its application to the panel on the bioequivalence studies with Exubra, an inhalation drug and device combination that was ...06 Dec, 2016, 02.00 AM IST
- Panic signals in India as USFDA asks drug companies to repeat Semler’s studiesFDA inspections had found significant instances of misconduct and violations of federal regulations, including substitution and manipulatio...25 Apr, 2016, 02.01 AM IST
- Drug applications based on Semler's data unacceptable: USFDAThe letter informs the sponsor that it must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an accep...22 Apr, 2016, 07.47 PM IST
- US Food and Drug Administration issues data integrity notice to Indian CRO SemlerThis is another regulatory blow to the Indian drug industry, with several top pharmaceutical companies already under the watch of the US FD...22 Apr, 2016, 04.08 PM IST
- Nine new drugs under clinical stage: Dr Reddy'sAccording to a filing with US SEC, the drug maker said as of March 31, 2014, it had 20 active products in the proprietary products pipeline.29 Jun, 2014, 02.30 PM IST
- In clinical trials, all are being punished for errors of few: Satish Reddy, Dr Reddy's LabsWe are a developing country with our own needs and we have made some commitments during Trade Related Aspects of Intellectual Property Righ...15 May, 2014, 09.58 AM IST
- Drug regulator asks Sun Pharma to halt clinical research at Mumbai laboratoryThe drug regulator took the step after discovering that Sun didn’t have the requisite approval from the central government for operating th...08 Nov, 2013, 07.23 AM IST
- GVK Biosciences' Ahmedabad unit clears USFDA auditThe company's Ahmedabad Clinical Pharmacology Unit successfully cleared US Food and Drug Administration audit with zero 483s/observations f...30 Jul, 2012, 09.42 PM IST
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