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Results For "USFDA"

1355 News Found

Briefs: Morepen Laboratories and Zydus Lifesciences
Drug Approval | March 27, 2023

Briefs: Morepen Laboratories and Zydus Lifesciences

The company is addressing these observations


Lupin announces successful completion of UK MHRA inspection of Pithampur facilities
Drug Approval | March 27, 2023

Lupin announces successful completion of UK MHRA inspection of Pithampur facilities

With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company


Osteoarthritis candidate MM-II showed durable pain relief in Global Phase 2b study
Clinical Trials | March 23, 2023

Osteoarthritis candidate MM-II showed durable pain relief in Global Phase 2b study

The data from this study show that MM-II has the potential to provide durable pain relief for our patients


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility


Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets
Drug Approval | March 21, 2023

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million


Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Drug Approval | March 18, 2023

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.


Biocorp and HRA Pharma to jointly develop a medical device innovation
Medical Device | March 16, 2023

Biocorp and HRA Pharma to jointly develop a medical device innovation

Biocorp will receive an initial milestone payment this year


Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP
Drug Approval | March 15, 2023

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP

Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.


Glenmark and Cediprof inks exclusive distribution agreement in US
News | March 10, 2023

Glenmark and Cediprof inks exclusive distribution agreement in US

The agreement is for USFDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets