Aurobindo Pharma receives USFDA Approval for uterine bleeding drug

aurobindo

Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Norethindrone Acetate Tablets USP, 5mg.

Norethindrone Acetate Tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea.

The approved product has an estimated market size of US$ 24 million for the twelve months ending November 2015 according to IMS, it said.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Aygestin Tablets, 5 mg, of Duramed Pharmaceuticals.

This is the 57th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.

Aurobindo now has a total of 230 ANDA approvals (199 Final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from USFDA.

Headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.

The company’s product portfolio is spread over 6 major therapeutic areas such as Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergies, supported by an outstanding R&D set-up.

It sells in over 150 countries.



Govt of India starts crack down on low-quality medicine makers The government of India has started conducting inspections at drug manufacturing units across the country to prevent the production of low-quality drugs and medicines in India.Typically, inspections are conducted by state authorities, while central agencies largely confine themselves to checking quality of final products put up on store shelves.H...
Cipla redraws Iran plans with new agreement, to invest Rs 121 cr Cipla said its wholly owned subsidiary of the Company in Netherlands will set up a 75% joint venture with Ahran Tejarat Company for manufacturing and marketing of pharmaceutical products in Iran.An earlier agreement executed by the Company with the Iranian firm has been terminated.The total investment will be euro 16.875 million, which comes to about...
Bliss GVS Healthcare wins three-year contract worth Rs 760 cr from Kenya Bliss GVS Healthcare Ltd said it won a three year contract worth $111.40 mln (Rs 760 cr) from Aon Kenya Insurance Brokers Ltd for provision of medical health care services in Kenya. Bliss GVS Pharma Ltd is a pharmaceutical company based in Mumbai, India.Bliss GVS primarily develops, manufactures and markets products across various therapeuti...
Alembic Pharmaceuticals receives FDA approval for hypertension tablets Alembic Pharmaceuticals Ltd said it received approval from the United States Food & Drug Administration for its abbreviated new drug application for Telmisartan and Amlodipine tablets for hypertension.The Telmisartan and Amlodipine Tablets are equivalent to the Twynsta tablets of Boehringer Ingelheim Pharmaceuticals, Inc.An Abbreviated New Drug ...
Lupin launches injectable iron formulations in India Pharma major Lupin Limited said it launched Iron Isomaltoside injectable iron formulation under two brand names “Isofer” and “Jilazo” in India.Lupin acquired the exclusive rights to market, distribute and sell the injectable formulation from Denmark based Pharmacosmos A/S.The product is currently marketed in 33 countries, including 21 European Union coun...
Dr Reddy’s Labs launches osteoporosis drug in the US Dr Reddy's Laboratories Ltd said it launched raloxifene hydrochloride tablets --used to treat osteoporosis -- in the US market.Raloxifene hydrochloride tablets are a therapeutic equivalent generic version of Evista (raloxifene hydrochloride) tablets. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, r...
Reliance Jio interconnect dispute with Airtel, Idea to end this month The dispute over providing interconnection facility is set to end in the next two weeks, with Bharti Airtel, Idea Cellular and Vodafone giving in to the demands of new operator Reliance Jio and the regulator.The decision to comply comes in the wake of a recommendation for a fine of Rs 3,050 cr to be imposed on the three companies for what it said amounte...
Sun Pharma to get dengue vaccine technology from ICGEB Pharma major Sun Pharma said it tied up with research organization International Centre for Genetic Engineering and Biotechnology to develop vaccines for dengue.The vaccine is targeted against all the four serotypes of Dengue virus that cause disease in humans and is being developed to commercialize in Indian and international markets.A serotype is a...
Aarti Industries to return Rs 96 cr to shareholders via buyback Speciality Chemicals company Aarti Industries Ltd said it will buy back12 lakh equity shares at Rs 800 each, aggregating to Rs 96 cr.The company´s Board of Directors approved the equity shares -- representing up to 1.44% of the company's base."The public announcement setting out the process, timelines and other requisite detail will be released in du...
Marksans Pharma gets USFDA approval for synthetic Vitamin D tablets Marksans Pharma Ltd said the United States Food & Drug Administration has given its approval for its paricalcitol capsules -- a synthetic equivalent of Vitamin D.Vitamin D is important for the absorption of Calcium from the stomach and for the functioning of Calcium in the body. Paricalcitol Capsules are therapeutically equivalent to the reference l...
India overdependent on China for medicines – study India may have emerged as a key supplier of generic and affordable medicine for the world market, but it has an "overwhelming dependence" on China for the raw material required to produce these drugs, industry association Assocham said.Indian companies depend on China to supply them with the main raw material in drug making -- known as Active Pharmaceuti...
Lupin licenses taste-masking technology from Monosol for paediatric tablets Pharma Major Lupin Ltd. said its US subsidiary, Lupin Pharmaceutical Inc., has agreed to license technology from Monosol Rx to develop multiple paediatric-focused products.Lupin would develop the pediatric products utilizing MonoSol Rx’s proprietary PharmFilm drug delivery technology.MonoSol Rx’s PharmFilm technology is a drug delivery platform tha...
Cadila to launch immunosuppressant drug in India Cadila Healthcare, a Ahmedabad headquartered pharmaceutical company owned by Zydus Group, said it has partnered with Switzerland-based global biopharmaceutical company Neovii to launch an drug to reduce the strength of the body's immune system in India.The drug named Grafalon is extensively used in solid organ transplants and stem cell transplant, said t...
Almebic Pharmaceuticals receives inspection report from USFDA Alembic Pharmaceuticals Ltd., said it received an Establishment Inspection Report from the United States Food and Drug Administration for the inspection carried out at their formulation facility at Panelav, Gujarat.The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held, in search of contamination....
Shilpa Medicare receives USFDA approval for generic bone marrow drug Shilpa Medicare Ltd said it received an approval from the United states Food & Drug Administration for Azacitidine injection.Azacitidine is used to treat myelodysplastic syndrome - a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells.The approval was received under ...