The Mexican Supreme Court by the end of 2013, published a landmark decision that now is publically obtainable that certainly will impact the legal framework of the Pharmaceutical Industry in Mexico. The Regulatory Agency in charge of granting the marketing authorizations in Mexico granted a generic company an approval for the same product as...
Strides Arcolab announced that Strides Pharma Global Pte. Ltd, Singapore and Strides (Australia) Pharma Pty Ltd, Australia, both wholly owned subsidiaries of Strides Arcolab have signed definitive agreements with certain wholly owned subsidiaries of Aspen Pharmacare Holdings Limited, a company listed on the Johannesburg Stock Exchange (Aspen), to a
By a News Reporter-Staff News Editor at Marketing Weekly News VANC Pharmaceuticals Inc. is pleased to announce that it has received Drug Identification Numbers from Health Canada for 5 new generic molecules as an initial notice of consent for new drug submissions. VANC will start manufacturing of these products once Notice of Compliance is receiv
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of th
-Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration provided the Company with notification regarding its...
The U.S. Food and Drug Administration's recent approval of Zarxio the first biosimilar product approved in the United States points toward growth in the contract manufacturing organization industry, according to Kalorama Information. The FDA believes that biosimilars will provide access to important therapies for patients who need them.
Research and Markets has announced the addition of the "Evolution of technologies for therapeutic antibodies: From mAbs to biosimilars" report to its offerings. In a release, Research and Markets noted that report highlights include:. The study aims to discuss the evolution of the therapeutic landscape of monoclonal antibodies from 1890 s to date w
Research and Markets has announced the addition of the "The Pharmaceutical Market: Greece" report to their offering. SWOT Political Economic Business Environment Industry Forecast Pharmaceutical Market Forecast Healthcare Market Forecast Prescription Drug Market Forecast Patented Drug Market Forecast Generic Drug Market Forecast OTC Medicine...
by Puja Chaurasiya Strides Arcolab Limited is acquiring Aspen's generic pharmaceutical business in Australia together with certain branded pharma assets for A$380 Mn ($300 Mn or approx R1,900 Cr) through its two overseas subsidiaries, Strides Pharma Global Pte Ltd (Singapore) and Strides (Australia) Pharma Pty. The transaction will be financed by c
Strides Arcolab Limited, a pharmaceutical company, through its wholly owned subsidiary Strides Pharma Pty Ltd., has agreed to acquire a portfolio of approximately 130 products, from a wholly owned subsidiary of Aspen Pharmacare Holdings Limited, a supplier of branded and generic pharmaceuticals, for a purchase consideration of AUD265 million.
According to news reporting out of Tehran, Iran, by NewsRx editors, research stated, "The growth of pharmaceutical expenditure and patients' out of pocket has motivated policy makers to encourage patients to substitution of brands medicines with their generic alternatives called generic substitution. Our news journalists obtained a quote from the r
Deal Type: Asset Transaction Deal Country: South Africa Deal Status: Announced Deal Value: 133.9840 USD. Aspen Pharmacare Ltd., a supplier of branded and generic pharmaceuticals and a wholly owned subsidiary of Aspen Pharmacare Holdings Ltd., intends to divest business unit which forms part of its pharmaceutical division to Litha Pharma Ltd., a div
ChemWerth, Inc., a pioneer in developing and supplying generic active pharmaceutical ingredients, announced it has been recertified as a member of the US Customs and Border Protection program, Customs Trade Partnership Against Terrorism. C-TPAT members cooperate with CBP and other participating government agencies, including the US Food and Drug
EU Falsified Medicines Directive- When benchmarking for expertise and experience in operating a Medicine Verification Service, look for EU Member States who have a fully operational system in place, not a pilot. Pick an Aegate country: for example BELGIUM. Over 6,000 pharmaceutical manufacturers must serialise and add tamper proofing to roughly 10
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration provided the Company with notification regarding its...
Irish pharma giant Endo International Plc has signed a definitive deal to acquire the US-based privately-owned company Par Pharmaceutical Holdings Inc from TPG. The deal is worth$ 8.05 billion, including assumption of Par debt. Rajiv De Silva, president and CEO of Endo International, said, "Our generics business, Qualitest, continues to be an extre
East Granby, CT 05/21/2015 This week's Picking Perfection, sponsored by Pcdata USA, included information from Amy Batista. Aurobindo Pharma USA is a generic pharmaceutical manufacturer and distributor and is a wholly-owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. About Pcdata USA Pcdata
WASHINGTON, May 21, 2015/ PRNewswire-USNewswire/ Today, eight groups representing a broad spectrum of physicians who prescribe biologics Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Clinical Immunology Society, Coalition of State Rheumatol
A firm that develops, produces, packages, markets and distributes generic pharmaceutical products for a vast range of medical indications, Lannett Company, Inc., has entered a definitive deal to acquire privately owned, Silarx Pharmaceuticals, Inc. and a related property entity, a maker and marketer of liquid generic pharmaceutical products.
DGAP-News: amp biosimilars AG/ Key word: Change of Personnel amp biosimilars AG strengthens Management and Supervisory Boards 20.05. 2015/ 08:00- amp biosimilars AG strengthens Management and Supervisory Boards- Gunnar Janssen switching from the Supervisory as CFO to the Management
DGAP-News: amp biosimilars AG/ Schlagwort: Personalie amp biosimilars AG: Personelle Verstrkung in Vorstand und Aufsichtsrat 20.05. 2015/ 08:00- amp biosimilars AG: Personelle Verstrkung in Vorstand und Aufsichtsrat- Gunnar Janssen wechselt vom Aufsichtsrat als CFO in den Vorst
Our news editors obtained a quote from the research from Food and Drug Administration, "Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of...
By a News Reporter-Staff News Editor at Biotech Week The Biotechnology Industry Organization and Georgia Bio commend Governor Nathan Deal for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines. Governor Deal signed Senate Bill 51 into law today. The policies outlined in the bill align with
Hospira, Inc. joined forces with the Alliance for Health Reform and Amgen to bring the U.S. Food and Drug Administration and industry leaders together today to discuss the future of biosimilars in the United States. Sally Howard, J.D., deputy commissioner for policy, planning, and legislation, U.S. Food and Drug Administration; Sumant Ramachandra