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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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Emcure’s Import Alert: Is there a way of knowing who will be next?

The U.S. FDA banned drug imports from the finished dosage form operations of Emcure Pharmaceuticals Ltd over concerns related to their manufacturing practices. As our previous analysis, four months ago, “Quality Alerts at Lupin, Hospira, Emcure and Union Quimico Farmaceutica”, had anticipated the problems at Emcure, we were not at all surprised.Now that Emcure, a top 20 drug maker in India, joins the growing ranks of companies with compliance concerns, are there others who are likely to get cited next? “Recalling” Emcure Emcure has been involved in multiple product recalls in recent times and while no warning letters have been posted yet, the reason for the product recalls were always, compliance concerns at Emcure. In February 2015, aseptic and GMP practices at Emcure’s operations had impacted product sterility and Emcure’s customer, Sagent Pharmaceuticals had to recall their Atracurium Besylate injections. At the same time, lack of assurance of product sterility was the reason cited by Heritage Pharmaceuticals (Emcure’s subsidiary in the U.S.) when they recalled their batches of Colistimethate & Rifampin injections. Last year, Teva was forced to recall almost 40,000 bottles of products manufactured at Emcure because "laboratory testing was not followed in accordance with GMP requirements." A ban on $500 million Emcure will impact U.S. pharmaceuticals Emcure's plant in Hinjawadi in Pune, India has three finished dosage form facilities which, in our assessment, are covered by the import alert. Emcure’s strength has been on producing injectable products and now it joins a growing list of sterile manufacturing plants where compliance is a concern. Concerns at sterile manufacturing operations of Hospira, Hikma Portugal, Bedford (which is now owned by Hikma) and others will make the import ban on Emcure have a significant impact on the US pharmaceutical market. It is hence not surprising that eight injectable products, made at Emcure, have been exempted from the import ban, a position usually taken by the FDA to prevent drug shortages. Privately held Emcure, with almost $500 million in sales and which counts private equity players like Bain Capital among its main investors, clearly has a tough road ahead. Regulatory overhaul in IndiaIn order to revive the brand image of the pharmaceutical industry in India, the government is planning to take several measures, which includes the overhauling of CDSCO, the regulatory body for drug quality standards in India.With the Indian regulator planning to undertake a massive drug inspection exercise, there are chances that now, Indian companies will encounter many more domestic compliance challenges as well. Warning Bells from the U.S.Last week, the FDA published the list of companies who have not paid their GDUFA facility fees. The GDUFA facility fee is paid annually by generic companies to continue to do business in the United States. Maybe it is time to wonder, why some companies are not paying the FDA? Especially since some on the list have made recent headlines due to problems in international regulatory inspections…While PharmaCompass covered the compliance issues at Polydrug Laboratories (India) & IDT Biologika (Germany) recently, there are others whose regulatory concerns are also available for review in the public domain. Fleming Laboratories and Smruthi Organics, have been on the FDA Import Alert list for quite some time now and Sharon Bio-medicine was issued a non-compliance report by the EDQM in 2013. Additional warnings from across the borderWhile not on the GDUFA payment defaulter list, data integrity concerns at Chinese API manufacturer, Zhejiang Hisun have already made Health Canada issue a notice to voluntarily quarantine drugs, made or tested with API from Hisun. Health Canada’s decision was based on a “trusted regulatory partner” so it would not be surprising if we see similar action from other agencies. Signs of European trouble In Europe, the EDQM has recently suspended some CEPs of European manufacturers like Polpharma (metoprolol tartrate & metoprolol succinate) and Synteco S.p.A (articaine hydrochloride & ropivacaine hydrochloride). A CEP suspension does not always result in a non-compliance report, however, there is a high degree of correlation between the two activities. Our viewWhile compliance issues at some of the companies mentioned above have not yet made headlines, at PharmaCompass, we strive to collate the latest industry developments to provide actionable intelligence so that we can continue to be your “trusted information partner”. After all, like Health Canada, using real-time information and taking a proactive approach towards compliance, will always ensure the health of patients and in turn generate better business.

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16 Jul 2015

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