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BIOEQUIVALENCE STUDIES
From oncology to obesity, Pfizer bets big on India for its next growth wavePfizer is prioritizing India for future growth. The company plans to launch new medicines here soon after their global release. Pfizer aims...- New drugs could reach market sooner as govt halves trial review timelineThe Indian government is shaking up the pharmaceutical sector by slashing the review period for manufacturing applications for new drugs to...
- CDSCO seeks views on level playing field for new drugsIn a significant shift for the pharmaceutical market, India's drug regulator is crafting new legislation regarding drug approvals. Under th...
- ET MSME Awards 2025: India's pharma MSMEs face existential choiceNew bio-equivalence rules promise safer drugs but could eliminate pharma manufacturers that make medicines affordable. Is there a middle gr...
- Dr Reddy's gears up for weight loss drug studyDr Reddy's Laboratories has received approval from India's drug regulatory authority to conduct a bioequivalence study for the weight loss ...
- Generics-only policy makes sense only when targeted at pharmacists, not doctorsThe generics-only prescription rule does not make sense when quality of drugs remains suspect. Many have pointed outthat the NMC clause wil...
- 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...
- Indoco Remedies receives EIR from USFDAIndoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
- Sun Pharma shuts two clinical pharmacology units in VadodaraAs per industry sources, the move would impact around 80 staffers at the two locations.
- Sun Pharma shuts 2 Gujarat R&D centres to cut costsSources said the company’s R&D centre at Gurgaon (started by erstwhile Ranbaxy) will now undertake the clinical research handled by the Vad...
- Wockhardt shares climb 2% after USFDA makes nil observationIn a regulatory filing, the company said no observations were made after the US drug regulator inspected its Bioequivalence centre.
- 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 ...
- European Medicines Agency suspends scores of drugs tested by Semler ResearchThe bioequivalence studies, necessary to gain approvals - were done by Indian CRO for large generic companies including Mylan Teva, Accord ...
- 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...
- 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...
- European Union health regulators suspect manipulation by GVK BioRegulators in many European countries including Germany are reportedly evaluating whether to suspend the use of over 100 medicines.
- 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...
- Health ministry suspends AP clinical research firm nod for clinical studyThe country’s drug regulator has suspended clinical research firm Axis Clinicals' permission to conduct all bio-availability and bio-equiva...
- Budget 2011: FIEO for extension of weighted deduction to expenditure incurred on clinical trialsFIEO states that removal of the said anomaly will promote in-house R&D in India.
- Strides Arcolab ready to supply Swine Flu drugDrug firm Strides Acrolab on Tuesday said it is in a position to supply Oseltamivir Capsules, the only available medicine against Influenza...
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