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FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs expresspharma
August 21, 2020
This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted by an applicant.
Alembic Pharma sees domestic business growing in double digits this fiscal expresspharma
July 13, 2020
The company said that it aims to grow its presence in the specialty and chronic therapy segments.
Caplin Steriles signs distribution agreement with Xellia Pharmaceuticals expresspharma
July 08, 2020
The former to license five of its injectable ANDAs to Xellia Pharmaceuticals for commercialisation in the US.
Aurobindo Pharma plans to launch 50-60 products in US in FY21 expresspharma
June 23, 2020
Aurobindo Pharma's US business posted a growth of 27 per cent year-on-year to Rs 11,484 crore in FY20.
Glenmark receives ANDA approval for Fingolimod Capsules expresspharma
June 19, 2020
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya Capsules, 0.5 mg, of Novartis Pharmaceuticals.
Naari completes acquisition of ANDAs from Intas Pharmaceuticals expresspharma
June 15, 2020
The portfolio acquired comprises eight US FDA approved ANDAs and two products pending approval.
Cipla receives final approval for generic version of Migranal with a Competitive Generic Therapy Des expresspharma
May 21, 2020
Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product.
Laurus Labs receives USFDA approvals for two ANDAs under PEPFAR expresspharma
May 20, 2020
Laurus Labs is one of the few players in the ARV segment to receive approval for TLE 400 tablets.
Glenmark receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg expresspharma
March 24, 2020
According to IQVIATM sales data for the 12 month period ending January 2020, the Farxiga Tablets, 5 mg and 10 mg market achieved annual sales of approximately $1.8 billion.
MedPharm Completes FDA Inspection contractpharma
March 06, 2020
MedPharm, a global contract development organization for topical and transdermal products, has successfully completed a pre-approval inspection by the FDA at its facility in Durham, NC.

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