Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 167

Results For "FDA"

1704 News Found

Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr
News | July 23, 2021

Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr

Q1 FY22 consolidated revenue grew 6% to Rs. 1,808 crore from Rs. 1,712 crore in Q1 FY21. Q1 FY22 Net Profit was Rs. 84 crore (vs. Rs. 149 crore in Q1 FY21).


EMA grants ODD to Saroglitazar Mg
News | July 21, 2021

EMA grants ODD to Saroglitazar Mg

Earlier, the USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC


Jubilant Pharmova’s Roorkee facility placed under import alert
News | July 16, 2021

Jubilant Pharmova’s Roorkee facility placed under import alert

The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.


Sequent Scientific announces EUGMP approval for tablets
News | July 15, 2021

Sequent Scientific announces EUGMP approval for tablets

The company has already embarked upon significant expansion in Turkey


Unichem receives tentative approval for ANDA of Sitagliptin tablets
News | July 11, 2021

Unichem receives tentative approval for ANDA of Sitagliptin tablets

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Pfizer and BioNTech expects third dose clinical studies of COVID-19 vaccine in August
News | July 09, 2021

Pfizer and BioNTech expects third dose clinical studies of COVID-19 vaccine in August

The companies anticipate clinical studies to begin in August, subject to regulatory approvals


Triastek closes US $50 Mn Series B Financing
News | July 01, 2021

Triastek closes US $50 Mn Series B Financing

In addition to supporting the ongoing development of the first IND-approved product in clinical trials, the proceeds will also be used to expand the 3D printed drug product pipeline


Strides completes EU GMP inspection at Puducherry facility
News | June 29, 2021

Strides completes EU GMP inspection at Puducherry facility

The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection


Lupin Launches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in the US
News | June 27, 2021

Lupin Launches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in the US

It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.


Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion