Last Updated on September 30, 2024 by The Health Master
USFDA approval
Alembic Pharmaceuticals, a leading global pharmaceutical company, has achieved a significant milestone with the US Food and Drug Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for Albendazole Tablets USP, 200 mg.
This USFDA approval marks a crucial step in expanding the company’s global footprint and providing essential healthcare solutions to patients worldwide.
Key Highlights:
Therapeutic Equivalence:
Alembic’s Albendazole Tablets have been deemed therapeutically equivalent to the reference listed drug product (RLD), LAlbenza Tablets, 200 mg, manufactured by Impax Laboratories.
This ensures that patients can receive a high-quality, affordable alternative to the original brand-name medication.
Therapeutic Indications:
Parenchymal neurocysticercosis: A parasitic infection caused by the larval stage of the pork tapeworm, Taenia solium.
Cystic hydatid disease: A parasitic infection caused by the larval stage of the dog tapeworm, Echinococcus granulosus.
Cumulative USFDA Approvals: Alembic has now secured a total of 214 ANDA approvals from the USFDA, including 186 final USFDA approvals and 28 tentative approvals. This impressive achievement underscores the company’s commitment to innovation, quality, and regulatory compliance.
Expanding Global Reach
The USFDA approval of Albendazole Tablets further strengthens Alembic’s position as a trusted provider of generic pharmaceuticals in the US market.
By offering high-quality, affordable medications, the company is helping to improve access to essential healthcare for patients in need.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
USFDA approval granted for Theophylline Extended-Release Tablets
USFDA approval granted for generic drug for Scalp Psoriasis Treatment
USFDA approval granted for Brimonidine Tartrate Ophthalmic Solution: Lupin
USFDA approval granted for Glycopyrrolate Oral Solution
USFDA approval granted for blockbuster drug for Cancer treatment
USFDA approval granted for Valbenazine Capsules
Pharma Industry seeks relief: Decriminalization of DPCO provisions
QR Code Mandate: Pharma Industry calls for Financial Support
Drug recall: Baxter recalls various batches of Tisseel due to dissolution time
USFDA approval granted for Theophylline Extended-Release Tablets
Pharma Retailers demand redesign of medicine packs: Strip Cutting
USFDA inspection with positive VAI to Dr. Reddy’s Lab for its API facility
Govt issues new uniform code for marketing of Medical Devices
Over 340 Pharma Companies overdue for USFDA inspection in India and China
APTI demands reservation of all Pharma Jobs for Pharmacy Graduates
Pharma Breakthrough: India starts producing API Clavulanic Acid
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
