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cGMP Non-Compliance Recap 2019

In 2019, concerns over quality of medicines continued to dominate news headlines. The ‘sartan’ recall saga, which was triggered in July 2018 after the European Medicines Agency (EMA) began reviewing medicines containing valsartan, for the presence of the carcinogenic impurity N-nitrosodimethylamine (NDMA), continued well through the year and had a major impact on the global pharmaceutical industry. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) In 2019, French drugmaker Sanofi announced it would recall popular heartburn medicine Zantac in the United States and Canada, after medicines containing the active ingredient ranitidine were also linked with the presence of NDMA. Several generic drugmakers followed suit and as concerns mounted over cancer-causing impurities in commonly used antacid, diabetes and blood pressure medicines, the EMA’s human medicines committee (CHMP) requested that marketing authorization holders (MAHs) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines and test all products at risk. The review will include all generics and over-the counter (OTC) products. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) In Spain, a drug mixup caused children to develop a form of werewolf syndrome (a rare and curious condition that causes excessive hair growth) after they were given a wrong medication to treat heartburn. Swiss drugmaker Novartis battled data manipulation allegations involving its US$ 2.1 million gene therapy Zolgensma and a new book titled ‘Bottle of Lies’, by investigative journalist Katherine Eban revealed how quality and efficacy of generic drugs is being compromised by companies in India and China, the two main countries that produce these drugs for the US consumer. The book release sent the FDA in damage control mode, with senior officials issuing statements supporting the agency’s generic drug framework. Inspection statistics PharmaCompass reviewed the FDA and EDQM’s inspection statistics for the calendar year 2019 and found that the FDA’s Drug Quality Assurance division conducted 1,138 inspections with 2,280 inspections being performed by the member states of the EDQM. The FDA was the most active in the United States with 478 inspections followed by India where the inspection count was 193 and then in China where the count stood at 117. With regard to non-compliance, there were 73 inspections which were classified as OAI (6.4 percent of the total number of inspections) by the FDA while the EDQM issued 20 non-compliance reports (0.87 percent of all inspections). The highest number of facilities which failed to meet FDA’s standards were in the United States (29), followed by India (18) and then China (13). From an inspection success rate perspective, firms in the United States passed 94 percent of their inspections while the success rates in India and China were 91 percent and 89 percent respectively. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) FDA investigators have identified persistent challenges while conducting foreign inspections, raising questions about the equivalence of foreign to domestic inspections. For example, while domestic inspections are almost always unannounced, FDA’s practice of pre-announcing foreign inspections up to 12 weeks in advance gives manufacturers the opportunity to fix problems. A US Government Accountability Office preliminary analysis of FDA data revealed that from fiscal year 2012 through 2016, the number of foreign drug manufacturing establishment inspections increased. However, from fiscal year 2016 through 2018, both foreign and domestic inspections decreased—by about 10 percent and 13 percent, respectively. FDA officials attributed the decline, in part, to difficulty in filling jobs abroad and on the paucity of inspectors. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) While the FDA is actively working on increasing the number of inspectors, according to FDA officials, it could take two to three years before the new staff is experienced enough to conduct foreign inspections. Concerns over manufacturing quality in India re-emerge In 2019, there was a surge of OAI classifications and FDA warning letters issued to the manufacturing sites of many major Indian pharmaceutical companies. The FDA issued warning letters to Aurobindo Pharma, Cadila Healthcare, Emcure Pharmaceuticals, Glenmark, Indoco Remedies, Jubilant, Lupin, Mylan, Strides and Torrent Pharmaceuticals. There are more warning letters expected as Form 483s issued after inspections at the facilities of Sun Pharma, Cipla and Lupin continue to reveal problems. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) The Form 483 issued by the FDA, following the inspection at Sun Pharma’s Halol facility, highlighted that Sun “failed to establish and implement controls which ensure data integrity” while Cipla’s finished pharmaceuticals manufacturing facility in Goa got classified as Official Action Indicated (OAI) by the FDA following a September 2019 inspection in which the FDA investigators had issued a 38-page Form 483. Regulatory actions lead to potential supply disruptions into US These regulatory actions have now begun to impact the supplies of generic pharmaceuticals into the United States. Injectable drugs, which constantly feature on the drug shortage list, had Cadila and Pfizer announce the discontinuation of their supplies to the United States. Following FDA’s warning letter to Cadila, the firm informed the FDA that it would permanently cease production of injectable drug products for the United States. In 2019, Pfizer announced that two manufacturing sites in India, which it had acquired through its US$ 17 billion acquisition of Hospira, will cease manufacturing operations. The sites located near Chennai (Irungattukottai) and Aurangabad employed 1,700 people. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) The Irungattukottai site received an FDA warning letter in 2013 and in 2016, Pfizer halted production at the plant after a PIC/S (short for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) joint inspection with regulators from four international agencies — MHRA (Medicines and Healthcare products Regulatory Agency of the UK), USFDA (United States Food and Drug Administration), TGA (Therapeutic Goods Administration of Australia) and Health Canada — found various quality control problems. Firms like Vital Laboratories and Alchymars ICM SM Private Limited, which had been issued warning letters in the past, were placed on import alert by the FDA. Concerns over operations at firms responsible for valsartan recalls The FDA and EDQM both raised concerns over the operations at Lantech Pharmaceuticals Limited, a firm which undertakes contract solvent recovery for valsartan API manufacturing operations. Solvents recovered by Lantech and samples collected from Lantech’s equipment were found to contain mutagenic impurities. Inspections at Lantech revealed that the firm failed to implement a procedure for investigating unknown peaks in recovered solvent chromatograms observed during analytical testing — an oversight which had led to the cancer-causing impurities not being detected in the ‘sartan’ APIs. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) The FDA also raised data-integrity concerns at the facility as it was “routinely deleting recovered solvents gas chromatography (GC) data older than three months permanently, without any backup” and adequate controls. As a fallout of the “sartan” recall, warning letters were issued to Mylan and Jubilant over their valsartan manufacturing operations. Novartis’ data manipulation scandal In a shocking announcement, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues with Novartis’ gene therapy — Zolgensma. Zolgensma was acquired by Novartis in April 2018 when in a bid to secure its leadership position in gene therapy, Novartis struck a deal to acquire Illinois-based AveXis Inc for US$ 8.7 billion. The gene therapy, intended to treat children less than two years of age with the most severe form of spinal muscular atrophy (SMA), is priced at US$ 2.1 million, making it the world’s most expensive drug. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) On May 24, 2019, the FDA approved Zolgensma and a month later, on June 28, the agency was informed by AveXis (the product's manufacturer) that its personnel had manipulated data from an in-vivo murine potency assay. The FDA used this information to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. According to information shared by the FDA, the product that was administered in the Phase 1 clinical trial was manufactured by a different process than the product that was administered in the Phase 3 clinical trial and the animal toxicology studies. Because the manufacturing processes were different, interpretation of the overall clinical trial and nonclinical study results depends on understanding the characteristics of the Phase 1 version of the product in relationship to the characteristics of the Phase 3 version of the product. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) AveXis’ investigation report revealed that the firm became aware of the data manipulation as early as on March 14, 2019, more than two months prior to the BLA approval. However, AveXis did not inform the FDA of the issue until over a month after the BLA approval. If AveXis had informed FDA of this issue prior to the BLA approval, there was a possibility that the approval would have been delayed beyond the PDUFA goal date of May 31, 2019. The FDA assessment, however, stated that although the BLA would have eventually been approved, it is carefully assessing this situation and remains confident that Zolgensma should remain on the market. While managing the crisis, Novartis CEO Vas Narasimhan acknowledged that the company could have handled the furor surrounding Zolgensma better. Novartis’ AveXis fired its former chief scientific officer Brian Kaspar in connection with the data manipulation scandal, although Kaspar’s lawyer said he did nothing wrong and is ready to defend his name as needed. The Swiss drugmaker could face possible civil or criminal penalties, the FDA has said. Our view Over the past years, PharmaCompass has provided on-time coverage of quality concerns that have emerged at manufacturing operations around the world. With the widespread use of generic drugs and the majority of them being manufactured in India and China, data-integrity within manufacturing operations and assurance of product quality continue to remain key concerns. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available) While streamlined, compliant operations still seem like a distant dream, in 2019, the former promoters of Ranbaxy, the Singh brothers were finally arrested for misappropriating funds. The legal action was in connection with their stake sale in the Indian drug behemoth to Japanese drugmaker Daiichi Sankyo for US$ 2.4 billion. The sale took place in 2008, months before the US Food and Drug Administration (FDA) banned imports from two of Ranbaxy’s Indian plants as a result of widespread data falsification by the firm. That was the start of troubles for the duo, as Daiichi later took them to court for allegedly suppressing and misrepresenting facts at the time of sale. We hope there is a lesson in this for the industry so that companies improve their practices of falsifying data and the focus shifts towards patient safety rather than minimizing cost and maximizing profit. View our Interactive 2019 cGMP Compliance Recap Dashboard (Free Excel Available)

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13 Feb 2020

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Teva CEO steps down; FDA Warning Letters to firms in Japan, India & China

This week, Phispers highlights more bad news for Israeli drugmaker Teva, along with news on the ‘overwhelming efficacy’ of blood thinner Rivaroxaban over Aspirin, Sanofi’s plans to resubmit its application for Sarilumab, Denmark’s entry into the tug of war for hosting the EMA headquarters and are routine round up of global non-compliance concerns. Teva CEO steps down, as another bribery probe emerges and discussions of a split start The chief executive of Teva Pharmaceutical Industries, Erez Vigodman, stepped down after serving for three years. He has been replaced by Chairman Yitzhak Peterburg for the interim period. Teva is the world's biggest maker of generic drugs. In the last five years, he is the third CEO to vacate the position. A sudden change in the company’s leadership came just two months after the resignation of Sigurdur Olafsson, the former head of Teva’s main business unit — generic medicines. Both the executives played an important role in Teva’s US $ 40.5 billion purchase of Actavis Generics last year, touting it as a move that would provide growth. Instead, the acquisition led to more bad news. In a short statement after leaving, Vigodman stated: “I believe that now is the right time for me to step down. It has been a privilege to lead Teva, and I am proud of all we have accomplished. I am confident that the company’s future is bright.” A lot of bad news has already piled up for Teva’s investors since the New Year. This includes the following negative events: The market is criticizing Teva’s acquisition of Actavis (Allergan’s generics division) for US $ 40 billion in cash and shares. Teva’s acquisition of Mexican company Rimsa proved to be a catastrophe. Rimsa's plants are now shut down. Apart from the bad decisions over acquisitions, Teva is also involved in two legal wrangles. One was a case of bribery in developing countries, in which Teva agreed to pay US $ 519 million to US authorities after paying bribes to officials in Mexico, Ukraine and Russia to boost sales. Another legal issue involves the investigation of Teva over bribe allegations by Israeli authorities which came up a day after Vigodman stepped down. A US district court ruling invalidated four patents out of five on its top seller — the multiple sclerosis drug Copaxone. The ruling, issued in late January, may open the door to generic competition (Novartis and Mylan) for thr drug that generates a fifth of Teva’s US $ 20 billion in annual sales. In the company’s own words: “New products stemming from that asset (Copaxone) would be unexpectedly delayed, while prices of its copycat medicines are likely to remain under pressure in the US, prompting a cut to its 2017 profit forecast.” Following the resignation, at the company's earnings call earlier this week, analysts started asking if Teva would consider a split-up? FDA issues Warning Letters to Indian, Japanese & Chinese firms Sato Pharmaceutical, a company established in 1939 in Japan, received a warning letter from the FDA as it failed to establish an adequate system for monitoring the conditions of its cleanroom environments. Following the inspection, the firm revised its standard operating procedure related to the “Aseptic Production Area”, however, the FDA found the response to be deficient. FDA inspectors also uncovered that the company had not performed the necessary smoke studies to evaluate air flow characteristics of its open Restricted Access Barrier System (RABS). The company released sterile products manufactured on the aseptic processing line, without studies to demonstrate unidirectional airflow over the exposed sterile product during processing. Although, Sato renovated its RABS to use a closed design and conducted validation studies, the response was found deficient as it does not address the quality of the products which had already been released to the U.S. market using the original open RABS design. An active pharmaceutical ingredient (API) manufacturer in India, Resonance Laboratories Private Limited also received a warning letter from the FDA as the inspectors raised concerns over the facilities water systems and cleaning validation methods. The FDA found that the firm’s response to the inspection observations had failed to perform a retrospective review of CGMP deficiencies on the quality of the products which had already been distributed within the United States. PharmaCompass had shared the news about the compliance troubles at Resonance in November, 2016. The FDA also issued warning letters this week to two Chinese firms who had been placed on its Import Alert list last year. The warning letters sent to Ausmetics Daily Chemicals (Guangzhou) Co., Ltd. and Zhejiang Bangli Medical Products Co., Ltd. showed that the companies failed to sufficiently test the batches of the final product they produced and did not adequately confirm the quality of the incoming active raw materials. Bayer’s Rivaroxaban shows 'overwhelming efficacy' over aspirin Back in 1897, a young scientist at a Bayer laboratory in Wuppertal, Germany — Dr. Felix Hoffmann — synthesized a chemically pure and stable form of acetylsalicylic acid (ASA), which became the active ingredient in Aspirin™. Since then, Aspirin has been an important medicine due to its remarkable pain relief, as well as cardiovascular (CV) event prevention properties. The medicine has truly stood the test of time. Last week, Bayer AG and its development partner Janssen Research & Development announced the successful outcome of a large-scale Phase 3 study -- COMPASS, involving 27,402 patients, that assessed the effect of blood thinner Xarelto (rivaroxaban) in preventing major adverse cardiac events (MACE). The trial was scheduled to finish next year but was stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE — which includes cardiovascular death, myocardial infarction and stroke —reached its pre-specified criteria for superiority over aspirin. The drug could potentially be used on 30 million patients with coronary artery disease (CAD) and peripheral artery disease (PAD), in addition to the roughly 25 million patients it sees in the atrial fibrillation market, says Bayer. Xarelto is currently the only non-vitamin K antagonist oral anticoagulant (NOAC) currently under assessment in this high-risk patient population. The drug is already on the market for reducing the risk of stroke and blood clots. Sanofi fixes problems in French plant, to resubmit application for Sarilumab In 2014 and 2015, while reviewing new drug applications, the US Food and Drug Administration (FDA) had raised manufacturing questions in only one Complete Response Letter (CRL) sent to the applicant. However, by mid-December, 2016 “an astonishing 40 percent were specifically tied to questions the agency raised about the manufacturing capabilities of a drugmaker or its contractor.” Manufacturing issues derailed sales forecasts through new drug approvals of Sanofi, AstraZeneca, Valeant, Bristol-Myers Squibb, Pfizer and many others. In October 2016, Sanofi received the FDA’s Form 483 for it’s Le Trait facility in France since manufacturing deficiencies were discovered during a routine good manufacturing practice (cGMP) inspection where Sarilumab and Dupilumab are manufactured. This plant is involved in one of the last steps in the manufacturing process of Sarilumab — an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderate to severely active rheumatoid arthritis (RA) which is a combined program of Sanofi and Regeneron. Due to the manufacturing issues, FDA issued a CRL regarding the Biologics License Applications (BLA) for Sarilumab. Sarilumab is said to become a blockbuster after beating the world’s best-selling drug AbbVie's Humira (adalimumab) in a head-to-head trial. Analysts have previously predicted the drug could bring in more than US $ 1 billion by 2020. In response to the letter received from the FDA, the French company has filed a comprehensive corrective action plan with the FDA and is “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market. In January 2017, Sanofi and its drug development partner Regeneron Pharmaceuticals said they have resolved manufacturing defects at Le Trait facility, which caused the delay for the approval of Sarilumab drug. Sanofi’s CEO Olivier Brandicourt said: “We worked closely with the US FDA to implement a corrective plan and got positive feedback". Assuming the formal inspection will also play out positively, the companies have decided to resubmit their application for Sarilumab by the end of March. Denmark officially bids for relocation of EMA head office The future location of the European Medicines Agency (EMA) — one of the regulatory jewels of the EU — has been a consistent topic of conversation since the outcome of the Brexit vote. The intervention of the Japanese government in early September 2016 brought the EMA issue further into the open when a 15-page letter came up where Japanese officials told their counterparts in the UK that if “the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D funds and personnel to Continental Europe.” And now, Denmark is also in the list of countries that are bidding for EMA headquarters’ relocation. Copenhagen’s candidacy launch on February 8 comes in the wake of similar launches by Amsterdam, Milan, Stockholm, Barcelona and Dublin. Only the Czech Republic and Estonia have ruled themselves out, according to the Financial Times. Therefore, we may see a 20-way tug of war amongst cities that want to host the EMA. The Danish Medicines Agency is excited about the Danish government’s decision. Thomas Senderovitz, Director General of the Danish Medicines Agency, said: “The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life science cluster. Major international pharmaceutical companies have a presence in Copenhagen, and we offer a strong administration and unique culture for collaboration between the health sector and universities in Denmark and southern Sweden”. As the news came out, healthcare giant Novo Nordisk backed and supported the decision of the Danish Government. India’s Strides plans to spin off API unit Just two months after Perrigo agreed to sell its entire shareholding in Perrigo API India to Strides for INR 1000 million (US $14.8 million), Strides announced an organizational restructuring plan. As per the plan, Strides has decided to move away from its business-to-business (B2B) model to a business-to-consumer (B2C) model, which includes de-merging and listing its APIs business, exiting probiotics and capping its investment in the biotech business which was also approved by SeQuent Scientific, which bought into Shasun several years ago. SeQuent also has a veterinary drug business. Strides Shasun plans to rename itself as Strides Pharma. Post restructuring, the new Strides Pharma will comprise its retained formulations business having four US FDA-approved plants in India, Europe and Singapore, and three research and development (R&D) centers. This business will have a front-end presence in the regulated markets of Australia, US and the UK and emerging markets of Africa and India. Last year, Strides Shasun had mentioned they plan to hive off its commodity focused API manufacturing unit as a separate business. Strides — with two API manufacturing facilities, one in India and one in the UK — is a global supplier of painkiller (Ibuprofen), anti-epileptic medication (Gabapentin) and anti-acidity medication (Ranitidine). Strides had said that it would retain API capacities required for captive use while setting up a separate company for manufacturing low-margin APIs such as Ibuprofen, Gabapentin and Ranitidine.

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16 Feb 2017

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Novartis’ plant shut down creates urgency to find alternatives to Chinese APIs

With Novartis shutting two plants in Germany and one in India by 2016-end, the global reliance on China for bulk drugs has increased even further, raising serious concerns over safety, supplies and national security. Which plants? Last week, Novartis announced it will be shutting three plants of its generic business – Sandoz – by the end of 2016. The first plant is in India and the other two are located in Germany, in Gerlingen and Frankfurt. Frankfurt, manufacturer of a key antibiotic intermediateThe Frankfurt plant is where Sandoz manufactures 7-ACA (7-aminocephalosporanic acid), the core chemical structure (building block) for producing a whole host of cephalosporin antibiotics. The reason given for closure -- prices of the cephalosporin active pharmaceutical ingredients (APIs) and intermediates have collapsed as Asian competitors have dumped excess capacity on the market. The shutdown of the Frankfurt facility means that the global reliance on China for APIs, used to produce antibiotics (such as cephalosporin) and especially 7-ACA, will increase only further. Chinese APIs are already a security threat for India India produces a third of the world's medicines, mostly in the form of generic drugs. However, according to an Oct 2014 report by a Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), more than 90 percent of the key raw materials (intermediates and APIs) that go into making at least 15-odd essential drugs come from China.The drugs listed include the most commonly used painkiller such as paracetamol, aspirin; antibiotics such as amoxicillin and ampicillin, cephalexin, cefaclor, ciprofloxacin, ofloxacin, levofloxacin; first line diabetes drug metformin; and antacid ranitidine. There are no domestic producers left for many drugs such as penicillin-G, and its derivative 6-aminopenicillanic acid, or 6-APA.Since India is still receiving a large quantity of 7-ACA from Germany (confirmed by the import statistics available on the PharmaCompass database), 7-ACA and its derivatives were not mentioned in this report.As per news reports, the Indian government is now worried about over-dependence on imports from China. "Any deterioration in relationship with China can potentially result in severe shortages in the supply of essential drugs to the country. Additionally, China could easily increase prices of some of these drugs where it enjoys virtual monopoly," said Bart Janssens, partner, BCG, in a news report published in The Economic Times. Recognizing the national healthcare security challenge facing India, the Department of Pharmaceuticals (DoP) has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients.’ As part of this initiative, the Indian government intends to build cluster parks to boost India’s self-reliance on Chinese imports. Quality, environmental concerns over Chinese AntibioticsChinese supplies of 7-ACA have been plagued with multiple issues in the past. In 2012, for instance, several Chinese drug companies were accused of manufacturing 7-ACA using contaminated ‘gutter oil’, instead of more expensive soybean oil. Gutter oil is reprocessed oil manufactured from waste oil and animal fat collected from restaurants’ fryers, drains, grease traps and slaughterhouses. Chinese restaurants can get through a lot of cooking oil and this waste oil fuels a highly profitable gutter oil black market as there are few other outlets, such as biofuel production, for this by-product.Similarly, antibiotic pollution in the rivers of China is a serious cause of concern for the Chinese. Our previous analysis, “Antibiotic resistant superbugs: deadlier than cancer and closer to you than you think” provides a detailed overview regarding the challenge being faced. However, with growing focus on antibiotic pollution in China, a shutdown of factories failing pollution norms would be a severe setback for the global antibiotic supply chain. In addition to these challenges, quality concerns have been raised during international regulatory inspections of some of the leading antibiotic producers in China, like Zhuhai United and North China Pharmaceutical Company. South African stock outs of essential drugs a global concernThe outcomes of these challenges are already being felt in countries such as South Africa which are facing an acute shortage of critical drugs. According to a report published in Groundup, drug shortages in South Africa’s health facilities have become a crisis. The story mentioned the situation in a hospital (Stanger Hospital) in Ilembe District KwaZulu Natal, where 200 products were out of stock. These included various doses of morphine, some antibiotics and antiretrovirals, especially paediatric ones, used to treat HIV. “About a hundred patients per week are going without ranitidine which prevents stomach ulcers. Several Ilembe facilities are even out of stock of paracetamol tablets,” the Groundup report said. There are multiple reasons for the drug stock outs. However, unprofitability because old, off-patent products are being sold by manufacturers at prices very close to the cost of production has played a major role. Firms are abandoning such products and seeking higher return alternatives. In addition, due to quality failures suppliers are unable to provide lifesaving medications to the South African population. Our ViewThe problems of stock outs and quality concerns in South Africa can easily expand across the world and can’t be addressed until the global pharmaceutical industry reduces its reliance on China for bulk drugs and intermediates. It remains to be seen if the threat to the global supply chain will make Novartis reconsider its decision or drive a national government to buy the Frankfurt facility.

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30 Jul 2015

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Find PharmaFlow Article for NCGC00024387-02

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APIs // Active Pharmaceutical Ingredients

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