Zydus gains final USFDA approval for Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and…
The tablets are indicated for the acute and maintenance treatment of schizophrenia
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USFDA
Indoco Remedies receives U.S. FDA approval for generic Cetirizine tablets
Indoco Remedies secures final approval from the U.S. FDA for its generic version of Zyrtec Allergy Tablets
Alembic gains USFDA final approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and…
The approved ANDA is therapeutically equivalent to the reference listed drug product, Lamictal XR Extended-Release Tablets, 200…
Gilead Sciences signs licencing agreements with six companies to manufacture, commercialise…
Dr Reddy’s Laboratories, Emcure Pharma, Hetero Drugs and Mylan Labs (a subsidiary of Viatris), are among the six companies that…
Alembic gains EIR for its Oral Solid Formulation Facility(F-1) at Panelav
The inspection took place from July 17, 2024, to July 26, 2024
USFDA concludes GMP inspection at Dr Reddy’s R&D centre
The inspection was conducted from September 16 to September 20, 2024. The inspection closed with zero observations
Eugia Steriles receives EIR from US FDA
The inspection was conducted between March 28, 2024 to April 05, 2024
Strides Pharma subsidiary receives USFDA approval for 60 mg Fluoxetine tablets
Strides Pharma Global secures approval for Fluoxetine Tablets, completing its portfolio for the US market
Sun Pharma and Moebius Medical gain fast track designation for MM-II for the treatment of…
MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended…
Strides gains USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg
Strides is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity for Theophylline Extended-Release Tablets, 300…