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BIOEQUIVALENCE
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...- Drug applications with unanswered queries to be rejected within 30 daysThe message was conveyed through a public notice issued by The Central Drugs Standard Control Organisation (CDSCO) on May 4. It said applic...
- Lupin launches generic anti-diabetic tablets in USPharma major Lupin has launched its generic anti-diabetic medicine in the United States. The medicine is dapagliflozin and metformin hydroc...
- Marksans Pharma gets USFDA nod for generic Benzonatate capsulesMarksans Pharma has received final approval from the US Food and Drug Administration for its generic version of Benzonatate capsules used t...
- Lupin gets tentative nod from USFDA for generic Sugammadex injectionLupin Ltd, a prominent name in the pharmaceutical world, revealed on Tuesday that it has gained tentative approval from the US health autho...
- 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...
- 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.
- Granules India gets USFDA nod for pain relief drugThe approved product is bioequivalent to the reference listed drug product (RLD), Tylenol tablets, extended release.
- 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.
- 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 ...
- 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...
- Dr Reddy's launches Atorvastatin calcium tablets in USDr Reddy's said that it has launched Atorvastatin calcium tablets, a bioequivalent generic version of Lipitor tablets in the US.
- 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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