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Results For "USFDA"

1312 News Found

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US
News | January 28, 2023

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA


Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Drug Approval | January 25, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid


Gland Pharma’s Q3 FY23 revenue stood at Rs. 938 Cr with gross margin of 54%
News | January 24, 2023

Gland Pharma’s Q3 FY23 revenue stood at Rs. 938 Cr with gross margin of 54%

The company is adding new capabilities of Combi-line for Microsphere, additional Bag line and lyos for the Penem block in Pashamylaram facility in Hyderabad and will be earmarking capital for further building on its Biosimilar CDMO facility


Mandaviya urges stakeholders to partner with India to leverage opportunities at WEF Davos
News | January 19, 2023

Mandaviya urges stakeholders to partner with India to leverage opportunities at WEF Davos

India is working towards augmenting health infrastructure and have initiated multiple schemes to strengthen health systems and improve health service delivery


Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer
News | January 14, 2023

Dr. Reddy’s acquires trademark rights of breast cancer drug PRIMCYV from Pfizer

Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA


Sun Pharma launches Palbociclib, a novel targeted therapy for advanced breast cancer
News | January 12, 2023

Sun Pharma launches Palbociclib, a novel targeted therapy for advanced breast cancer

Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies


Zydus launches Topiramate Extended-Release Capsules
Drug Approval | January 07, 2023

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.


Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma
Drug Approval | January 05, 2023

Briefs: Gland Pharma, Supriya Lifescience, Hindustan Unilever and Eugia Pharma

Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.


Themis Medicare launches Lenzetto for treatment of menopausal symptoms
News | January 04, 2023

Themis Medicare launches Lenzetto for treatment of menopausal symptoms

It ensures sufficient serum estradiol levels to alleviate menopausal symptoms