Glenmark gets USFDA nod for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg
The tablets will be distributed in the US by Glenmark Pharmaceuticals US
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ANDA approval
Glenmark Pharma gets ANDA nod for Apremilast Tablets, 10 mg, 20 mg and 30 mg
Apremilast Tablets, 10 mg, 20 mg and 30 mg, is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen
Lupin gets tentative nod from US FDA for apalutamide tablets
This product will be manufactured at Lupin’s Pithampur facility in India
Zydus gets US FDA approval for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg
Isotretinoin Capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment
Ajanta gets US FDA approval for Topiramate ER Capsules
As per the settlement with the innovator, Ajanta can launch Topiramate on February 1, 2026 or earlier under certain circumstances
Marksans receives USFDA approval for Guaifenesin ER Tablets (OTC)
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways…
Lupin gets US FDA nod for Bromfenac Ophthalmic Solution, 0.09%; Metoprolol Succinate ER Tablets USP
Both products will be manufactured at Lupin’s Pithampur facility in India
Lupin gets US FDA approval for Doxycycline Hyclate Delayed-Release Tablets USP
This product will be manufactured at Lupin’s Pithampur facility in India
Lupin US FDA approval for Fluocinolone Acetonide Topical Oil
This product will be manufactured at Lupin’s Somerset facility in the US
Lupin gets US FDA approval for Norgestrel and Ethinyl Estradiol Tablets USP
This product will be manufactured at Lupin’s Pithampur facility in India.