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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...
- Centre set to amend rules to simplify drug testing processThe Indian government is amending drug regulations to expedite the approval process for clinical trials and bioavailability/bioequivalence ...
- Veeda Clinical Research names Mahesh Bhalgat as group CEOMahesh Bhalgat has been appointed as the Group CEO of Veeda Clinical Research, an Ahmedabad-based clinical research organization. Bhalgat h...
- 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...
- A Mumbai company is working on a potential coronavirus medicineFavipiravir, an off-patent drug originally owned by Japanese drug maker Fuji, holds potential against RNA viruses, one of which is Covid-19...
- 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...
- We will certainly take a relook at our quality systems: Sandeep Singh, Alkem LaboratoriesThere is only one crirical observation has been made by UK MHRA against the company's QA process
- Budget 2013: Allow weighted deduction for pharmaceutical expenditure outside the approved R&D facility, says FICCIFICCI also added that some of the activities though directly related to research and development are not eligible for weighted deduction.
- 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...
- 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...
- 78 combo drugs set for returnIn a respite to pharma companies who have been asked to withdraw 294 combination drugs worth around Rs 3,500 crore.
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