Generics Industry News Search
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March 2010 News Archive |
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Perrigo Company today announced that it has signed a definitive purchase agreement to acquire Orion Laboratories Pty, Ltd. for approximately $48 million in cash...
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Baxter International Inc., a global, diversified healthcare company, and ApaTech, a private equity-backed, U.K.-based orthobiologic products company, today announced a definitive agreement whereby Baxter will acquire all of the outstanding equity of ApaTech for total consideration of up to $330 million...
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The U.S. Patent and Trademark Office has tentatively rejected certain claims in a key patent for blockbuster anti-clotting drug Plavix, which is co-marketed by Sanofi-Aventis SA and Bristol-Myers Squibb Co.
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Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for the generic version of Flomax (tamsulosin hydrochloride) 0.4mg capsules...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall Capsules...
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Glenmark Generics, (GGI) USA, a subsidiary of Glenmark Generics (GGL), has received ANDA approval from the United States Food and Drug Administration for Ropinirole Hydrochloride tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva's favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium)...
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AstraZeneca Plc, the U.K.'s second-biggest drugmaker, sued India's Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the U.S. before 2014....
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Drug developer and medical products company Covidien said Wednesday it has launched a generic version of the painkiller Actiq....
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Ranbaxy Laboratories Ltd, India's largest drug maker by revenue, failed to gain approval to launch the generic version of blockbuster urinary drug Flomax, but it may still get a one-time payment for enabling the launch of its generic version in the US market, according to an industry executive, who didn't want to be named...
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This time, it's Teva - trying to bring a generic version of Vytorin to market. Once again, New Merck has, as of Tuesday, brought federal district court suit in New Jersey (the earlier ones were filed in Delaware), to halt that possibility - for at least 30 months...
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Pfizer Inc. said buying Ratiopharm GmbH would help the U.S. company beat generic competition and give the German drugmaker a bigger sales network in an acquisition plan presented today, according to two people with knowledge of the situation...
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Pfizer Inc. wheeled out its chief executive and pledged to invest in growth as it sought to win the bidding to buy German generic drugmaker Ratiopharm GmbH, sources familiar with the situation said....
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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analysed opportunities in launching a generic version of Abatacept. Based on its proprietary Pipeline Patent Intelligence GenericsWeb reveals that the lack of a legislated approval route and data exclusivity period for biogenerics in the US leaves generic developers of Abatacept products wondering how and when they may file for FDA approval of a biogeneric, and when they might expect to be in a position to launch...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has been sued by Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for Oxymorphone Hydrochloride Extended-Release Tablets, 40mg. Watson's Oxymorphone Hydrochloride Extended-Release Tablets product is a generic version of Endo's Opana(R) ER which is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Opana(R) ER had approximately $245 million in brand sales for the twelve months ending December 31, 2009, according to IMS Health...
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Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Fluorouracil Topical Cream USP, 5% (fluorouracil cream). ...
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The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (Sun) in a Lanham Act case concerning the identification of a "polymorph" in the labeling of Sun's generic Protonix ...
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Actavis has announced the divestment of its Bulgarian distribution company, Higia EAD, to a local private investor, Rossitsa Veselinova Velikova. ...
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Mylan today reported that it has identified multiple flaws within a purported bioequivalence study sponsored by Bayer Inc. of Canada. The study compared Bayer's antihypertensive Adalat XL tablets, 60 mg, marketed in Canada, to Mylan's approved generic version, Mylan-Nifedipine Extended Release tablets, 60 mg, marketed in Canada. ...
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Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has launched an authorised generic version of its Timoptic-XE (timolol maleate ophthalmic gel forming solution). ...
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Watson Pharmaceuticals, Inc., today announced that it has reached a settlement agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving outstanding patent litigation related to Watson's generic equivalent version of Actos (Pioglitazone Hydrochloride) 15mg, 30mg and 45mg tablets...
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AstraZeneca today announced a license and supply agreement with Torrent Pharmaceuticals Ltd. Torrent will supply to AstraZeneca a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint...
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Caraco Pharmaceutical Laboratories, Ltd. has launched oxaliplatin injections. These 50mg and 100mg oxaliplatin injections, which are therapeutically equivalent to Eloxatin from Sanofi-Aventis, received approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA)....
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Intellipharmaceutics International Inc. today announced that Novartis Pharmaceuticals Corporation and Celgene Corporation have settled their patent suit in the U.S. District Court for the District of New Jersey, and Elan Pharma International Ltd. has settled its patent suit in the U.S. District Court for the District of Delaware, with Intellipharmaceutics Corp., a wholly-owned subsidiary of Intellipharmaceutics International, and its licensee Par Pharmaceutical, Inc. over a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR (dexmethylphenidate hydrochloride). The terms of the settlements are confidential and remain subject to regulatory and court approval....
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As American consumers increasingly turn to generic drugs as a way to reduce their medical costs, the continued manufacturing problems of one generic maker stand out...
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Ranbaxy Laboratories is looking forward to achieve some big achievements in the coming two years. Its parent company Daiichi is confident that Ranbaxy Labs will end all the issues regarding manufacturing facilities and other regulatory issues with US FDA, very soon. ...
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"Bloomberg" reports that Teva Pharmaceutical Industries Ltd. has sued Mylan Inc., which is seeking to market its own generic version of birth control pills LoSeasonique and Seasonique...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX(R) (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg....
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Perrigo Company today announced that it has begun shipping Ketotifen Fumarate ophthalmic solution, 0.025%, a generic version of Zaditor...
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Ranbaxy Laboratories Limited, along with its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc. announced today that they have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America, resolving outstanding patent litigation related to Ranbaxy's generic equivalent version of Actos (Pioglitazone Hydrochloride) 15 mg, 30 mg and 45 mg tablets. Under terms of the agreement, Takeda granted Ranbaxy a non-exclusive royalty free license to its U.S. patents covering Actos. Under the terms of the agreement, Ranbaxy has certainty in the launch of its generic equivalent formulation of Actos on August 17, 2012, or earlier under certain circumstances....
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The drug wars just get nastier and nastier. Novopharm, which is asserting a damage claim in the range of $86 to $138 million against Eli Lilly Canada under s. 8 of the Patent Medicines Notice of Compliance Regulation, applied for a Mareva injunction against Eli Lilly Canada because it became concerned that Lilly Canada might become judgment proof...
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem(R) LA product. Watson intends to launch its generic version of Cardizem(R) LA immediately. ...
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Drug maker Lupin has obtained a US Food and Drug Administration (USFDA) approval to market Imipramine Hydrochloride tablet on prescription basis. The said drug would be available in the strengths of 25 mg....
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Shire plc announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2mg, 3 mg, and 4mg guanfacine hydrochloride extended release tablets, INTUNIV....
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Mylan Inc. today announced that it has entered into settlement agreements with Takeda Pharmaceutical Co. related to two treatments for type 2 diabetes: Actoplus Met, 15 mg/500 mg and 15 mg/850 mg, known generically as Pioglitazone Hydrochloride(HCl) and Metformin HCl Tablets, and Actos, 15 mg, 30 mg and 45 mg, known generically as Pioglitazone HCl Tablets. ...
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Teva Pharmaceutical Industries Ltd. announced today that the parties to the patent litigation regarding Barr's U.S. generic version of Schering's Temodar have entered into an agreement pending resolution of Schering's appeal to the Federal Circuit of the U.S. District Court's decision holding the '291 Patent unenforceable. Under the terms of the agreement, subject to limited exceptions, Teva will only market a generic product should the Federal Circuit uphold the District Court's decision. Furthermore, the agreement grants Teva the right to commence selling its generic product as of August 2013, during the period of Schering's pediatric exclusivity....
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Teva Pharmaceutical Industries Ltd. announced today that it has entered into a definitive agreement to acquire ratiopharm, Germany's second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of $3.625 billion. The transaction is subject to certain conditions including relevant regulatory approvals. On a pro forma basis, the combined company would have had 2009 revenues of $16.2 billion. Teva expects to complete the transaction by year-end 2010.
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Glenmark Generics Inc., USA , the subsidiary of Glenmark Generics Ltd, today announced that the USFDA has granted final ANDA approval for Moexipril Hydrochloride (HCl) and Hydrochlorothiazide tablets - the generic version of Schwarz Pharmaceuticals' Uniretic. The product is currently available and will begin shipping immediately....
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The Food and Drug Administration has approved a generic anxiety drug made by Actavis, the generic drug maker announced Wednesday. ...
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Sun Pharmaceutical Industries Ltd. announced that the USFDA has granted its subsidiary an approval for its ANDA for Promethazine Hydrochloride and Codeine Phosphate Oral Syrup, 6.25 mg/5 ml and 10mg/5ml...
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New York-listed Dr Reddy's Laboratories Ltd (DRL) on Wednesday got the US drug regulator's final nod to sell its generic version of Sanofi Aventis SA's anti-allergic drug Allegra D-24...
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Pharma Major, Lupin Limited announced today that its U.S subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Eszopiclone tablets, 1 mg, 2 mg and 3 mg from the U.S. Food and Drug Administration (USFDA)....
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Valeant Pharmaceuticals International today announced that it has signed a binding agreement to acquire a private branded generics and over the counter (OTC) company located in Brazil for approximately US$28 million...
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Synthon Pharmaceuticals Inc. is confirming today that it has been sued by Eli Lilly and Company and Icos Corporation in connection with the filing of Synthon's Abbreviated New Drug Application (ANDA) for Tadalafil 20 mg...
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On Sunday night, the US House of Representatives voted by a narrow 219-212 margin to agree to the version of the Patient Protection and Affordable Care Act (H.R. 3590) that the Senate passed on December 24, 2009....
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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Indomethacin for Injection. Indomethacin is therapeutically equivalent to the reference-listed drug INDOCIN(R) I.V., by Lundbeck, Inc....
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AMRI today announced that it along with sanofi-aventis U.S. LLC, has filed a motion for a preliminary injunction in the United States District Court for the District of New Jersey seeking to enjoin Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) from the commercial distribution of generic versions of Allegra-D 24 Hour (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets in the U.S....
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Gedeon Richter Plc. (Richter) and Indian Astron Research Ltd. (Astron), a research arm of Intas today announced that they signed a development collaboration agreement on 26 February 2010. According to the agreement, the two companies have undertaken to jointly develop several generic products as selected by Richter
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GIA announces the release of a comprehensive report on Biosimilars markets. The market for biosimilars in US, Europe, and Japan is projected to exceed $2 billion by 2015. This is primarily driven by patent expiries of major recombinant protein-based therapeutic products, increasing demand for cost-effective biosimilars, and an aging population requiring biologic drugs for the treatment of chronic and complicated conditions such as kidney diseases or cancers...
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Aurobindo Pharma, a leading APIs and generic formulations maker from India, has received Canadian approval for the company's generic topiramate pills...
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Pfizer lost patent suits in South Korea relating to the cholesterol pill Lipitor, the world's bestselling drug, ending an almost two-year legal battle in the Asian country....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of the anticoagulant, Argatroban(R) injection, 100mg/mL....
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Bayer has again moved Delhi high court with another petition against Indian firm Cipla alleging patent violation of its kidney cancer drug Nexavar (sorafenib tosylate). The German drug maker had earlier approached High Court seeking an interim stay on Cipla's prospective generic on sorafenib, which is currently under regulatory review....
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The European Medicines Agency has recommended the recall of all batches of generic Plavix from Swiss drugmaker Acino made at a factory in India, due to quality concerns about the heart drug....
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The Delhi High Court has turned down a plea by US pharma major Bristol-Myers Squibb (BMS) to ban India's Ranbaxy Laboratories from launching a generic version of its patented hepatitis B drug Baraclude...
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A proposal that would ban patent-settlements between brand-name pharmaceutical companies and makers of generic medicines won't be included in legislation overhauling the U.S. health-care system....
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Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Limited, announced they have received final approval from the United States Food and Drug Administration for Calcipotriene ointment 0.005%...
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Daiichi Sankyo Company and Ranbaxy Laboratories announced that Daiichi Sankyo will establish Daiichi Sankyo Espha on April 1st, 2010. Daiichi Sankyo Espha will be marketing generic drugs, as well as...
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Drug firm Ranbaxy Laboratories today said it has entered into a pact with US-based Pfenex Inc for developing biosimilars (drugs manufactured with the use of biotechnology)....
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Sanofi-Aventis SA and Bristol-Myers Squibb Co. scored victories on two fronts in their decade-long battle to keep generic copies of the blockbuster blood thinner Plavix off the U.S. market...
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Uh-oh, Big Pharma. Generics maker Teva Pharmaceutical Industries bested all of you during the 12 months that ended September 2009. With a chart-topping 12.3 percent growth during the period, Teva raised its revenues to $15.7 billion and its ranking on the list of drugmakers to No. 11, according to newly released stats from IMS Health....
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On March 8, 2010, Health Canada released its final guidance documents relating to the approval pathway for subsequent entry biologics (SEBs) in Canada...
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Cephalon Inc. lost its bid to dismiss antitrust suits, including one by the U.S. Federal Trade Commission, over patent-infringement settlements it reached regarding generic versions of the sleep-disorder drug Provigil....
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Pfizer Inc., the world's biggest drug maker, sued to prevent Teva Pharmaceutical Industries Ltd. from selling a generic version of the Viagra impotence drug
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Indoco Remedies has entered into a long-term drug supply pact with Aspen Pharmacare, the largest pharmaceutical manufacturer in Africa and one of the top 20 generics manufacturers in the world...
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Sanof-Aventis, the world's third largest drug maker, has approached a US court against Wockhardt for challenging the patents of Allegra (fexofenadine hydrochloride), one of the largest selling anti-allergic drugs in the world...
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Ranbaxy Laboratories Ltd. Tuesday denied a media report that said its Japanese parent plans to delist the Indian company...
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Hospira Inc., the world leader in generic injectable pharmaceuticals, today announced it has completed the acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for approximately $400 million....
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Generic drugmaker Stada, which sources say is in the sights of U.S. drugs major Pfizer, would not block a takeover bid that was attractive for shareholders, its chief executive said...
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The Food and Drug Administration has approved a generic drug for treating restless leg syndrome, agency records show...
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The Food and Drug Administration has given a tentative approval to a generic drug for treating heparin-induced thrombocytopenia, agency records show...
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India has asked the World Health Organization (WHO) to confine itself to its public health mandate and not associate with the attempts to redefine "counterfeit" medicines...
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Savient Pharmaceuticals, Inc. announced today that the FDA has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy....
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Is Daiichi Sankyo plotting to take over Ranbaxy Laboratories completely? Indian media is reporting that the Japanese drugmaker wants to buy out the 36 percent of Ranbaxy it doesn't already own and then meld the two companies together...
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Barring further delays, Sigma Pharmaceuticals should release today the gory details of writedowns stemming from its $2.2 billion purchase of generics drugs house Arrow Pharmaceuticals...
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Apotex Inc has challenged the U.S. Food and Drug Administration's decision to give rival Teva Pharmaceutical Industries Ltd six months of exclusive marketing for generic versions of the widely-used blood pressure medicines Hyzaar and Cozaar...
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Avesthagen Limited, a leading systems biology biotechnology company headquartered in Bangalore, India announced the commencement of the manufacture of two of its biosimilars at Inno Biologic's Putra Nilai facilities in Malaysia....
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India is ready to launch a formal dispute against the European Union at the World Trade Organization over EU seizures of Indian generic drugs, the Indian Trade Secretary said on Wednesday...
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We are pleased to announce the launch of temozolomide available in 5mg, 20mg, 100mg, 140mg, 180mg and 250mg strength capsules...
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