Biocon's insulin facility in Malaysia clears inspections for European marketThe facility, set up with an investment of $275 million, is designed to manufacture recombinant human insulin and insulin analogs for the g...
Biocon shares drop after French regulator finds lapses at its plantANSM has raised deficiencies concerning two biosimilar products intended in the treatment of cancer and one intended for diabetes.
Biocon plunges 4% as French regulator decides to re-inspect facilityThe re-inspection will be to verify implementation of the proposed corrective and preventive actions, the company said.
ANSM gives GMP nod to Biocon, to re-inspect drug product unitBiocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow- up inspection of t...
GAVIS Pharma LLC looking to exit Bengaluru-based Wintac LtdGavis Pharma LLC is now exploring options to exit its listed Indian arm. Wintac Ltd was not part of the 2015 deal struck between Lupin & Ga...
CRO Lambda appoints Tausif Monif as Global PresidentLambda's expertise is in offering end to end clinical research and total drug development solutions to pharmaceutical companies worldwide.
India engaging with EU to sort out pharma issues: GovernmentIndia is engaging with EU to sort out regulatory issues and strengthen manufacturing practices following the 28-nation block's ban on aroun...
Government panel looking into GVK Bio data issue, says officialThe concerns raised by French drug regulator ANSM over the data integrity of GVK Bio have no basis, a senior official said.
India may contest EU move to ban 700 drugsIndia may contest a decision by the European drug regulator to recommend a ban on as many as 700 generic products tested by GVK Biosciences
EU bans 700 generic drugs for manipulation of trials by GVK BiosciencesMedicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...
EU regulator recommends suspension of drugs over GVK Bio dataThe recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on be...
GVK Biosciences may redo studies doubted by European drug regulatorKantipudi also opined that some of the customers may even ask GVK Bio to pay damages in the event of drug recalls related to the studies co...
Four European Union countries suspend authorisation of 25 drugs studied at GVK BiosciencesEuropean Medicines Agency (EMA) said in a statement that it is reviewing findings of non-compliance with good clinical practise at the GVK ...
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 Bio manipulated clinical trials of generic drugs: ReportsThe Federal Institute for Medicines and Medical Products, which issues the licences in Germany, confirmed it has been investigating the all...
GVK Bio under scanner of European Drug RegulatorThe review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission.
GVK Bio under scanner of European Drug RegulatorThe review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission.