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FDA haunted by problems at Chinese plant; Sun Pharma gets entangled in price gouging furor

Phispers brings you the latest in global pharma news, such as how the drug price hike uproar in the US is affecting Sun Pharma, how the UN may adopt a resolution on fighting the menace of antibiotic resistance and how bioelectronics is working towards improving diabetes care. And there is more on Zhejiang Hisun, Novartis and GSK. Import alert on Zhejiang Hisun continues to haunt the FDAA little over a month ago, Bloomberg highlighted the challenges of banning China’s Zhejiang Hisun. This week, the FDA had to exempt even more products to ensure supply sustainability in the United States. In addition to the 14 drugs which were exempted when the initial import alert was announced, Sulbactam Sodium and Mesna have now been excluded from the import alert list.The FDA had issued an indefinite ban on the Zhejiang Hisun factory. Yet, in order to avoid possible shortages of drugs, the FDA allowed the plant to continue to export 15 ingredients for use in finished drugs in the US, including nine key cancer medicine components. In the US, more than 80 percent of drug ingredients are produced overseas, in mainly China and India. The FDA has stepped up inspections in order to check quality. However, it relies on pharmaceutical companies to ensure the ingredients are up to the US standards. Sun Pharma’s unit gets summoned for price gouging in the USThe ripples of the ongoing uproar in the US over high drug prices can be felt in India. Last week, the US Department sent grand jury subpoenas to Sun Pharmaceutical Industries’ unit – Taro Pharmaceuticals. In a statement to the Securities Exchange Commission, Taro said two of its commercial executives in its US unit were summoned by the antitrust division of the Department of Justice (DOJ). The DOJ sought “communications with competitors and others” regarding the sale of generic drugs. Taro contributed US $ 230 million to Sun Pharma’s US $ 375 million revenue from the US last year.According to a news report, Taro has received notice for raising the price on clobetasol – a steroid that is sold as a topical ointment, cream, and gel – substantially between July 2011 and June 2014. The price of 15 grams of 0.05 percent topical ointment increased from US $5.75 to US $124.36 during the period, according to Truven Health Analytics. UN General Assembly to take up antibiotic resistance next weekNext week, we will know whether combatting the menace of antibiotic resistance will become an international priority or not. The United Nations will open its two-week long General Assembly in New York next week, where it will debate issues of global importance. On September 21, the assembly will host a “high-level meeting” on the threat of resistant bacteria. The assembly will showcase presentations from representatives of governments and non-profit and academic organizations. The same day, the UN is expected to adopt its first-ever resolution on the importance of combating antibiotic resistance, and perhaps also some sort of a commitment to action.According to estimates, antibiotic resistance kills 700,000 people around the globe each year, with 23,000 people dying each year in the US and 25,000 in Europe. After Novartis and GSK, Google now ties up with Sanofi This week, there was some big news in the field of bioelectronics, a novel field of medicine that is focused on fighting diseases by targeting electrical signals in the body. Sanofi and Verily (the life sciences unit of Google parent Alphabet) announced they would invest about US $ 500 million in a joint venture combining devices with services to improve diabetes care.The deal with the French drug maker Sanofi comes after British drug maker GlaxoSmithKline (GSK) and Verily created a new bioelectronics company. Verily is also working on the development of a smart contact lens in partnership with Swiss drug maker Novartis that has an embedded glucose sensor to help monitor diabetes. These partnerships are examples of growing ties between the pharma and tech sectors.There was more positive news from Sanofi. Last week, it received positive data from a Phase III study of their diabetes drug sotagliflozin. Considered the next-gen improvement on the SGLT2 (sodium/glucose cotransporter 2) inhibitors, investigators say that two doses of sotagliflozin were able to reduce A1C levels by 0.43 percent and 0.49 percent in patients with type 1 diabetes. GSK sells anesthetic drugs to South Africa’s Aspen for US $ 370 millionAs part of its drive to focus on core therapy areas, British drug maker GlaxoSmithKline is selling its portfolio of anesthetic drugs to South Africa's Aspen Pharmacare for around US $ 372 million (GBP 280 million).On Monday, the two companies announced that Aspen would pay GBP 180 million (US $ 238 million) for the products Ultiva, Nimbex, Tracrium, Mivacron and Anectinein, and an additional GBP 100 million (US $ 132 million) in milestone payments. The two firms have a long history of working together. GSK has already sold the US and Canadian rights to these drugs. The company earned around GBP 35 million (US $ 46 million) from the anaesthetics in the first half of 2016. Novartis finds ECA support in its battle over ban on toxic chemicalNovartis recently received significant support from the European Chemicals Agency in its battle over diglyme – a toxic chemical that Novartis used for making an ingredient found in two medicines.Last month, the ECA decided to support a Novartis request for a seven-year exemption from a pending ban on diglyme. The chemical is used to make indacaterol, an ingredient in treatments for chronic obstructive pulmonary disorder. The ban goes into effect in August 2017.A final decision, however, will be made by the European Commission. And, it is unclear when the decision will be made. However, a leading environment group – ChemSec -- has urged ECA to support the ban. ChemSec had insisted the ban should be upheld due to “socio-economic” costs associated with continued use of the chemical, as well as negative consequences for companies that produce potential alternatives.

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India cracks the whip on quality and compliance; Eli Lilly loses patent infringement case in China

This week, Phispers ferrets out global pharma news to bring you the latest on a drug for bipolar disorder, news about two Indian drug makers being put on import alert for refusing an FDA inspection and how GSK’s supply snags in Italy are hurting Denmark Former hedge fund manager who paid an FDA official for tipoffs found deadLast week, a hedge fund manager – Sanjay Valvani (44) – was indicted for allegedly paying a former US FDA official for inside information on product approvals. On June 20, he was reportedly found dead. According to a news report, Valvani was found by his wife at his Brooklyn, New York, home with a neck wound. A suicide note and a knife were also recovered from his home.Valvani had worked at Visium Asset Management. During 2005 to 2011, he had allegedly paid a monthly sum to Gordon Johnston, who once worked as a deputy director of the FDA’s Office of Generic Drugs, for tips. Indian pharma majors among 200 under scrutiny for quality of drugs sold For the first time in India, the Drug Controller General of India (DCGI) has launched inspections against 200 drug makers, including pharmaceutical biggies like Cipla and Pfizer, for allegedly selling poor quality medicines and for not complying with manufacturing norms. An official of the DCGI told a newspaper that the regulator has already inspected 36 drug manufacturing plants over the last three months. In the second phase, the DCGI will inspect 20 more facilities. Notices have also been sent to Cipla and Pfizer informing them of the impending inspection and the violations found in their products. Cipla maintained it has not received any intimation so far, while Pfizer did not comment. Phalanx Labs and Cheryl Labs refuse FDA inspection, put on the Red List The US Food and Drug Administration (FDA) banned two Indian drug manufacturers – Cheryl Laboratories and Phalanx Labs – from shipping products to the US after both the firms refused to allow FDA teams to visit their manufacturing sites for an inspection. Both the firms were put on FDA’s import alert list, also known as the Red List. According to the FDA policy: “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.” Cheryl Laboratories stopped FDA inspectors from visiting its facility in Navi Mumbai, while Phalanx did not let inspectors visit their site in Visakhapatnam. Cheryl makes creams, ointments, liquid pharmaceutical, antiseptic products and gels from its Navi Mumbai facility. Phalanx’s Vizag facility produces 15 active pharmaceutical ingredients (API) – including erectile dysfunction drugs, ulcer medications and anticoagulants – and chemical intermediaries. Eli Lilly loses patent infringement case in ChinaLast week, China’s apex court rejected the appeal of US pharmaceutical company Eli Lilly against Jiangsu-based Changzhou Watson Pharmaceutical in a long-standing patent infringement case.Eli Lilly and Changzhou Watson have been involved in patent infringement disputes for over a decade over Changzhou Watson’s production of olanzapine, an anti-psychotic drug. The court also overturned a previous ruling on patent infringement in favor of Eli Lilly, that had ordered Changzhou Watson to pay Eli Lilly millions in compensation. The investigators concluded that “the alleged infringement does not fall into the scope of patent protection in the case.”This is the first time that the apex court in China has designated technical investigators in a lawsuit to help clarify the technical details of the case. Using old compounds to create new drug for bipolar disorderBack in 2010, a group at the University of Oxford was looking for ways to treat bipolar disorder by using lithium. Though the drug is known to work well in bipolar disorder, it also has side effects. Therefore, the group – headed by a young physicians called Grant Churchill – asked a physician Justyn Thomas to screen all 450 compounds in the US National Institutes of Health (NIH) Clinical Collection, a library of drugs that had passed safety tests in humans but, for various reasons, had never reached the market. Thomas experimented with these compounds. What took birth was a drug called ebselen, which showed the same benefits as lithium. Churchill’s group did a small trial and found that ebselen could be used safely in healthy volunteers. The University of Oxford has now teamed up with a pharmaceutical company to run clinical trials of ebselen for bipolar disorder. Former CEO of Warner Chilcott acquitted in kickback caseLast week, the US federal court jury acquitted W. Carl Reichel – a former Warner Chilcott executive – of paying bribes to doctors to lure them to boost prescriptions. The decision is being seen as a setback for the US government which has initiated a new effort to hold high-ranking executives at pharma and other companies accountable for such activities. Federal prosecutors charged Reichel with crafting a strategy to give doctors money, free meals, and phony speaking fees in exchange for writing prescriptions of Warner-Chilcott drugs between 2009 and 2012. He was also charged with providing sales representatives with unlimited expense accounts in order to wine and dine with doctors. GSK’s supply snag in Italy creates drug shortage in DenmarkGlaxoSmithKline had temporarily suspended manufacturing at its Parma site in Italy that manufactures sterile products, to investigate environmental monitoring.This has led to shortages of commonly used opioid anesthetic in Denmark. The factory has now recommenced manufacturing. However, a small number of countries have experienced shortages of certain products since April. In Denmark, doctors said they were also running out of the anesthetic Ultiva, which is preferred by patients since they wake up quickly after surgery. The Parma factory also manufactures GSK’s new injectable drug Nucala for severe asthma and Benlysta for lupus. However, these were reportedly not in short supply. Zydus buys two ANDAs from Teva; Cipla heads to RussiaIndia’s Zydus Cadila has strengthened its US portfolio by acquiring two abbreviated new drug applications (ANDAs) from Israel's Teva. The divestiture by Teva is in line with a precondition to its acquisition of Allergan’s generic business. The ANDAs have been acquired by Zydus Cadila’s 100 percent subsidiary Zydus Worldwide DMCC and the transaction will be financed through the group's internal accruals. The estimated market size of the two ANDAs is around US $ 200 million.Meanwhile, another Indian company – Cipla – has entered into an alliance with Russia’s National Immunobiological Company (Nacimbio) for innovative antiviral medical products for HIV and hepatitis C treatment and technology transfer and API manufacturing. As a part of this agreement, Nacimbio, along with Cipla, will set up a manufacturing facility in Russia for antiretroviral drugs.

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FDA haunted by problems at Chinese plant; Sun Pharma gets entangled in price gouging furor

India cracks the whip on quality and compliance; Eli Lilly loses patent infringement case in China

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