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Alembic Pharmaceuticals
Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is ...
Drug makers Glenmark, Alembic Pharmaceuticals and Sun Pharma are recalling products in the US due to manufacturing issues, according to the US health regulator. Mumbai-based Glenmark is recalling two products in the market, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, is recalling Carvedilol tablets, used to treat heart failure, hypertension, and heart attack, in multiple strengths. The New Jersey-based firm is recalling 55,560 units of the affected lot due to "presence of a nitrosamine, N-Nitroso Carvedilol impurity above the current acceptable intake level," the USFDA stated. The company is also recalling 17,496 bottles of Carvedilol tablets as "results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm," it added. Glenmark initiated the Class II recall in August this year. USFDA said the company is also recalling 2
Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.
Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation, it added. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said. Citing IQVIA data, Alembic said Doxorubicin Hydrochloride Liposome injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) single-dose ...
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.