Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations Medical Dialogues Bureau2 Nov 2019 9:45 AM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sept 2019 10:15 AM IST"At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the...
Alkem Labs gets EIR from USFDA for its Daman facility Ruby Khatun Khatun25 July 2018 10:15 AM ISTNew Delhi: Drug firm Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its Daman...
Dr Reddy's gets nod to restart exports to EU from Vizag plant Ruby Khatun Khatun2 Dec 2017 10:30 AM ISTNew Delhi: Dr. Reddy's Laboratories said a German regulatory authority has allowed company's Visakhapatnam-based plant to restart production for the...
EMA accepts marketing authorization applications of Mylan and Biocon for 2 biosimilars Ruby Khatun Khatun2 Dec 2017 10:00 AM ISTHERTFORDSHIRE, England, PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for...
Mylan seeks EMA approval for 2 biosimilars Ruby Khatun Khatun9 Nov 2017 10:32 AM ISTNew Delhi: Biocon said that its partner Mylan has re-submitted marketing authorization applications with the European Medicines Agency for two...
Dr Reddys Vizag unit gets 6 observations by German regulator Ruby Khatun Khatun9 Sept 2017 9:32 AM ISTNew Delhi: Dr Reddy's Laboratories (DRL) said the German drug regulator has concluded the audit of its Visakhapatnam formulations facility with six...
