Cipla receives final approval for generic version of GlaxoSmithKline's IMITREX® (Sumatriptan Nasal Spray, 20 mg)

Mar 02, 2021

Mumbai (Maharashtra) [India], March 2 (ANI/PRNewswire): Cipla Limited today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for...

Indian pharma compliance standards improving, regulatory risks here to stay: Ind-Ra

Jul 07, 2020

Mumbai (Maharashtra) [India], July 7 : Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of...

Lyrus Receives US FDA Approval for Critical UTI Treatment in the US

Dec 15, 2023

Bengaluru (Karnataka) [India], December 15: The U.S. Food and Drug Administration (FDA) has approved Lyrus Life Sciences's Abbreviated New Drug Application (ANDA) for 'Methenamine...

Alembic Pharma gets US regulator final nod for skin ointment - Desonide Cream

Dec 09, 2022

According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved...

Drugs regulator refuses application of Dr Reddy's Lab for marketing authorisation of Remdesivir for COVID-19 treatment

Nov 02, 2020

New Delhi [India], November 2 : The top drug regulator has refused Dr Reddy's Laboratories' application, for full marketing authorization of anti-viral drug Remdesivir,...

Zydus Cadila approaches DCGI to use hepatitis drug for COVID-19 clinical trial

May 05, 2020

New Delhi [India], May 5 : The country's top drug regulator, Drug Controller General of India (DCGI), has received an application from Zydus Cadila,...