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Results For "USFDA"

1304 News Found

NATCO Pharma transfers Lenalidomide ANDA to Arrow
News | August 04, 2021

NATCO Pharma transfers Lenalidomide ANDA to Arrow

Arrow is the marketing partner in US


Morepen to start Sputnik V Vaccine commercial production in 4-6 weeks
News | July 28, 2021

Morepen to start Sputnik V Vaccine commercial production in 4-6 weeks

The first six batches are being shipped to the Gamaleya Center, Moscow for the quality approval


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


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


Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets
News | July 01, 2021

Lupin receives tentative U.S. FDA approval for Dolutegravir, Lamivudine and TLD tablets

TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg


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


Sun Pharma settles patent litigation for Revlimid
News | June 23, 2021

Sun Pharma settles patent litigation for Revlimid

Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain generic lenalidomide capsules


Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech
News | June 17, 2021

Dr. Reddy's Laboratories asked to pay $462.5 mn to Hatchtech

The company is exploring all legal options to challenge the award.


'We plan to invest Rs. 1,000 Cr in the next 3 to 4 years.' Priyanka Chigurupati, Executive Director, Granules Pharmaceutical Inc.
Interviews | June 10, 2021

'We plan to invest Rs. 1,000 Cr in the next 3 to 4 years.' Priyanka Chigurupati, Executive Director, Granules Pharmaceutical Inc.

In an exclusive interview with Rahul Koul of Indian Chemical News, Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc. USA shared details about the company's performance, R&D initiatives, Capex plan, CSR, and future outlook. Excerpts of the interview: