Furosemide

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

38 API Suppliers, 20 USDMF, 9 CEP/COS, 5 JDMF, 4 EU WC, 17 NDC API, 22 Listed Suppliers

DEVELOPMENTS

18 Drug(s) in Development

18 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

DOSSIERs // Finished Dosage Formulations

327 Dossiers, 93 FDA Orange Book, 103 Europe, 26 Canada, 27 Australia, 37 South Africa, 41 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 80MG, INJECTABLE;INJECTION - 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG
TABLET;ORAL - 40MG
TABLET;ORAL - 80MG
INJECTABLE;INJECTION - 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 26 Roquette, 25 Kerry, 17 BASF, 13 Microlex e.U, 11 Sigachi Industries, 9 Gangwal Healthcare, 6 Actylis, 6 DFE Pharma, 6 Gangwal Chemicals, 6 SPI Pharma, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Nanjing Well Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 3 Pharmatrans-Sanaq, 3 Ingredion Pharma Solutions, 3 Prachin Chemical, 3 Vasa Pharmachem, 2 Ulanqab Kema New Material, 2 DKSH, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Finar, 1 Zhejiang Huakang Pharmaceutical, 1 Ideal Cures Pvt Ltd, 1 Aeon Procare, 1 Rochem International Inc, 1 Seppic

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 30 Direct Compression, 21 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 19 Granulation, 15 Thickeners and Stabilizers, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 12 Coating Systems & Additives, 12 Parenteral, 11 Controlled & Modified Release, 11 Taste Masking, 9 Solubilizers, 7 Chewable & Orodispersible Aids, 5 Topical, 2 Emulsifying Agents, 2 API Stability Enhancers, 1 Soft Gelatin, 1 Rheology Modifiers

GLOBAL SALES INFORMATION

15 US Medicaid Prescriptions, 85 Finished Drug Prices

MARKET PLACE

37 APIs, 40 DOSSIERS // FDF

PATENTS

3 US Patents

3 US Patents

ANALYTICAL SOLUTION(s)

1 BioAnalytical Methods, 3 EDQM Standards, 2 USP Standards, 4 JP Standards, 10 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilations & Company Tracker #PharmaFlow, 28 News

Blog

Full Screen View

Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

This week, PharmaCompass reviews the recently released data on prescription drugs paid for under the Medicare Part D Prescription Drug Program in the United States in calendar year 2016. But first, let’s understand what is Medicare. Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled. Prescription drug coverage under this program was started in 2006, and is known as Medicare Part D. As part of this coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance companies and other private companies, known as plan sponsors, that offer prescription drug plans to their beneficiaries with varying drug coverage and cost-sharing requirements. In 2017, the Congressional Budget Office (CBO) had estimated that spending on Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare expenditures for the year. Click here to access the compilation of Medicare Part D Prescriber Summary Report According to the CBO, Medicare Part D is the most significant expansion of the Medicare program since it was created by Congress in 1965. With more than 1.48 billion claims from beneficiaries enrolled under the Part D prescription drug benefit program under its umbrella, our analysis of Medicare Part D provides valuable insights into how elderly Americans use prescription drugs. Top 10 drugs by cost: The ones that bore the highest cost burden for Medicare As in 2015, in 2016 too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion. As Gilead continued to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down 37 percent from US$ 7.03 billion in 2015. Click here to access the compilation of Medicare Part D Prescriber Summary Report Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion. Generic Name Number of Medicare Part D Claims Number of Medicare Beneficiaries Number of Prescribers Aggregate Cost Paid for Part D Claims (In USD) LEDIPASVIR/ SOFOSBUVIR (HARVONI) 141,665 52,782 12,097 4,398,534,465 LENALIDOMIDE 239,049 35,368 10,382 2,661,106,127 LANTUS SOLOSTAR (INSULIN GLARGINE, HUM.REC.ANLOG ) 5,028,485 1,075,248 245,447 2,526,048,766 SITAGLIPTIN PHOSPHATE 4,742,505 864,442 206,223 2,440,013,513 ROSUVASTATIN CALCIUM 6,012,444 1,560,050 249,981 2,322,724,007 FLUTICASONE/SALMETEROL 5,194,391 1,196,007 275,442 2,319,808,482 PREGABALIN 4,940,115 852,497 267,532 2,098,953,250 RIVAROXABAN 4,403,332 807,820 252,141 1,954,748,890 APIXABAN 4,455,782 826,969 231,631 1,926,107,484 TIOTROPIUM BROMIDE 4,153,162 903,494 235,564 1,818,857,361 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by claims: The most commonly used drugs of 2016 With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016. The number of Medicare Part D claims includes original prescriptions and refills. Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that were filed by almost 9.4 million beneficiaries. Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 ATORVASTATIN CALCIUM 494,973 44,595,686 9,435,633 AMLODIPINE BESYLATE 497,017 39,913,468 7,802,905 LISINOPRIL 490,452 39,469,840 8,009,954 OMEPRAZOLE 492,951 32,909,236 7,001,160 METFORMIN HCL 611,700 31,007,932 6,394,014 SIMVASTATIN 380,560 29,687,947 6,201,911 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 FUROSEMIDE 488,352 27,878,243 5,421,598 GABAPENTIN 555,997 27,627,466 5,363,382 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by prescribers: Medicines that were most popular with doctors Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had over 900,000 unique providers (or doctors) prescribing the drug. Albuterol (salbutamol) is used to provide quick relief from wheezing and shortness of breath while Diltiazem is used to prevent chest pain (angina). Also on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen. With more doctors prescribing Hydrocodone-Acetaminophen (an opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the series of new FDA initiatives to combat the epidemic of opioid misuse and abuse should change the position of opioids in the top 10 drugs by prescribers in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries ALBUTEROL SULFATE 985,427 13,100,354 5,417,718 DILTIAZEM HCL 931,159 8,142,004 1,982,550 POTASSIUM CHLORIDE 879,491 18,945,969 4,278,000 PEN NEEDLE, DIABETIC 677,210 5,281,778 1,795,046 LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 METFORMIN HCL 611,700 31,007,932 6,394,014 CEPHALEXIN 597,647 5,603,879 3,933,373 CIPROFLOXACIN HCL 594,129 7,000,081 4,851,657 AZITHROMYCIN 591,028 7,958,625 5,734,122 What does the future hold? Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations. Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries). Click here to access the compilation of Medicare Part D Prescriber Summary Report Last month, the Office of the Inspector General (OIG) reviewed the Part D claims data for the years 2011 to 2015 for brand-name drugs. The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs. With soaring drug prices being an issue for regular debate in the Unites States and President Trump announcing that his team will use strategies to strengthen the negotiating powers under Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under the Medicare Part D Prescription Drug Program will change in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report

Impressions: 2494

Excel Download

#PharmaFlow by PHARMACOMPASS

05 Jul 2018

Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017. Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers). The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed. Top Ten Drugs by Cost, 2014 [Most expensive for Medicare] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13 $1,224,835 $94,218 Elaprase 100 $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60 $2,901,115 $48,352 Naglazyme 129 $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15 $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services. Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!

Impressions: 7914

Excel Download

#PharmaFlow by PHARMACOMPASS

05 Jan 2017

Ranbaxy’s path of deception revealed in Singapore court order; Chinese, Indian, American and Spanish firms in compliance troubles

This week, Phispers brings you the latest on the Ranbaxy-Daiichi and Merck-Gilead cases. There is also news on Medtronics, which faces a whistleblower lawsuit. And Valeant, which has come under the scanner for allegedly defrauding insurers. Our compliance roundup updates you on companies across the world that faced regulatory action recently. Singapore court’s 373-page order reveals how Ranbaxy withheld information from DaiichiLast week, a report in The Indian Express brought to light how Ranbaxy deliberately withheld information from Japan’s Daiichi Sankyo in the Ranbaxy-Daiichi case. The information was based on a copy of the Singapore International Arbitration Centre’s (SIAC) order, passed in April 2016. The former owners of Ranbaxy – Malvinder Singh and Shivinder Singh – face a penalty of Rs 35 billion (US $ 523 million) and have until August 22 to challenge the SIAC order. The information implicates the Ranbaxy top brass in a “in a slew of irregularities, from fraud to falsehood.” In over 373 pages, the SIAC order lays out what it calls “the path of deception that Ranbaxy took and how it kept Japan’s Daiichi Sankyo — which bought Ranbaxy in 2008 for Rs 198 billion (US $ 2.96 billion) — in the dark even a year after its purchase”. The SAIC order was based on a 2004 Self-Assessment Report (SAR) prepared by the then head of research and development of Ranbaxy, Rajinder Kumar, for the company’s internal use. The contents of an internal report were not shared with Daiichi. The SAR listed over 200 drugs, including antiretroviral drugs for treating AIDS patients, for which Ranbaxy allegedly used fabricated data to bag approvals from regulators and authorities of more than 40 countries. Compliance roundup: Chinese, Indian, American and Spanish firms in compliance troubles Notice of non-compliance to Artemis Biotech: Artemis Biotech, a division of Themis Medicare in India, received a notice of non-compliance from European regulators. According to the regulators, the company had violated basic principles of data integrity within its instrument laboratory. And the relevant GMP data was outside the control of the quality management system. As an outcome of the inspection, the Certificates of Suitability (CEPs) granted for popular cholesterol lowering ingredient – simvastatin – have been suspended. Just three months ago another Indian manufacturer – Krebs Biochemicals & Industries – had its CEPs suspended for the same product.Alcor found to have unsuitable facilities: A Spanish manufacturer – Alcor SL – that manufactures liquid syrups for use in Spain was found not to have suitable facilities, personnel and materials to ensure proper compliance with GMP during an inspection in June this year. Although the company responded with a corrective action plan, it was found “insufficient”.Claris recalls injections in the UK: Indian manufacturer Claris Lifesciences recalled Furosemide injections in the United Kingdom as they had been inadvertently distributed in the country. The product was intended for sale in Australia. FDA’s warning letters to Zhejiang Medicine, Concept Products: While there was activity in Europe, the FDA issued a warning letter to Zhejiang Medicine (Xinchang Pharmaceutical Factory), a manufacturer of antibiotics like levofloxacin, daptomycin and vancomycin, for data integrity violations. Laboratory personnel were found “disguising testing”. The personnel were conducting unofficial testing that was being recorded in separate ‘R&D’ folders before conducting the officially reported sample analyses. Analysts were also found signing and dating microbiological testing laboratory worksheets five days before the test results were available and backdating laboratory worksheets for impurities and content testing by four days.The FDA also issued a warning letter to a Chinese manufacturer, Concept Products Limited, for “significant violations of cGMP regulations for finished pharmaceuticals”. It placed yet another Indian company Laxachem Organics and Chinese firm Yangzhou Hengyuan on import alert. Warning letter to Noven: A US-based patch manufacturer – Noven Pharmaceuticals – received a warning letter over quality concerns uncovered in its transdermal drug delivery systems (TDDS) such as Minivelle and Daytrana. The FDA expressed concerns over the scientific soundness of the company’s measurement method since the FDA stated that “your unsound methods could be masking product failures” and leading “to product detachment, expose the drug to other people, and other safety issues.” Now, Merck has to pay Gilead’s US $ 200 million legal feeIn March this year, Merck had won a legal dispute over sofosbuvir, the API in Gilead's multibillion-dollar drugs Sovaldi and Harvoni. The federal jury had ordered Gilead to pay Merck US $ 200 million in damages for infringing on patents for the hepatitis C drugs. But in June, the US Dristrict Judge Beth Labson Freeman threw out Merck’s victory and snatched back the US $ 200 million Merck had been awarded. Last week, the same judge added insult to Merck’s US $ 200 million-injury. Freeman said Gilead was entitled to relief from legal fees it had incurred while defending its case.Merck has been handed a US $200 million bill for Gilead's legal fees. Merck now intends to appeal in the case, saying the judge’s ruling “does not reflect the facts of the case.” FDA launches improved web-based version of its Orange BookThis week, the US Food and Drug Administration (FDA) launched an improved web-based version of its Orange Book – a publication on drugs approved on the basis of safety and effectiveness. The Orange Book is widely used by doctors and by the regulatory community for identifying which drug products are substitutable for one another. The improved Orange Book has an updated design and has more user-friendly search optionsFormerly known as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book had first appeared as a published list in 1980. It came online in 1997. Valeant allegedly defrauded insurers, may be under criminal investigation In one of the most serious probes faced by Valeant Pharmaceuticals, the Canada-headquartered company may be under criminal investigation over allegations that it defrauded insurers by hiding its ties with a mail-order pharmacy – Philidor – that boosted its sales. Prosecutors are probing whether Philidor made false statements to insurers about its ties with Valeant, while helping patients get coverage for the higher-priced Valeant drugs. According to a report published in The Wall Street Journal, criminal charges are likely to be levied against former Philidor executives and against Valeant as a company. The relationship between Philidor and Valeant has been under the scanner since October 2015, when questions were raised about Valeant's accounting. Novartis to expand capacity of monoclonal antibody plant in EuropeNovartis is investing US $ 100 million to expand its monoclonal antibody (mAb) capacity at a plant in Europe. The Swiss drugmaker has committed about US $ 1 billion to boost its biosimilar production in order to emerge a leading player in biosimilars. Novartis is beginning work on the mAb project that will boost capacity by 70 percent at the Novartis biotechnology center in Huningue, France. Meanwhile, the company has acknowledged that employees in South Korea may have been involved in rebate trickeries. But it says an investigation of similar accusations in Turkey uncovered no problems. In Turkey, Novartis considers the matter closed.In April, a prosecutor in Turkey had reportedly opened an investigation after receiving a copy of an email sent by an anonymous whistleblower to Novartis CEO saying the unit there paid consultants US $ 290,000 in 2013 and 2014 to win about US $ 85 million in business from government hospitals.Matters in South Korea are a lot serious. In South Korea, prosecutors want the government to suspend the company’s operations there after they indicted half-dozen executives for issuing improper rebates. German watchdog criticizes efforts to accelerate new drug approvalsGermany’s cost-effectiveness watchdog – the German Institute for Quality and Efficiency in Health Care – has criticized an effort by European regulators to accelerate approval for new medicines based on limited evidence. These concerns come at a time when regulators on both sides of the Atlantic are looking for new approaches to fulfill unmet medical needs through faster approval of drugs.Adaptive pathways approach is a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago, the European Medicines Agency (EMA) had launched a specific pilot program in this direction. However, the German watchdog maintained that the EMA failed to make its case that this approach for approving drugs can make a demonstrable difference. Medtronic faces whistleblower lawsuit for using devices under false pretensesMedtronic, a major medical device manufacturer, is facing a whistleblower lawsuit that claims it sought FDA approval for its devices under false pretenses. The devices were being regularly used for a purpose they weren’t intended to be used by the regulators.According to Dr. Vikas Saini, president of the Lown Institute, a Boston healthcare think tank, who has been following the case, the devices had been labelled ‘not for cervical spine use’. “Yet, in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine,” Saini said.Medical devices are lightly regulated by the FDA. Once cleared by the FDA, physicians used medical devices however they deem fit. Questions being raised on health of Clinton, Trump Donald Trump and Hillary Clinton are two of the oldest presidential candidates in the US history. While Clinton’s doctor certified that she “is in excellent physical condition” and Trump’s physician declared he would be “the healthiest president – ever”, these testaments are not being taken seriously in the absence of detailed medical records. Both Trump’s and Clinton’s doctors released brief assessments of their health recently. Television host Sean Hannity has aired a series of segments on Fox that cast doubts on Clinton’s health. Democrats, on the other hand, have been questioning Trump’s mental health. One congresswoman recently suggested he should undergo a “mental fitness test.”

Impressions: 5114

Excel Download

#Phispers by PHARMACOMPASS

18 Aug 2016

The silver lining in Ipca’s Import Alert blues

Ipca Laboratories finished dosage facilities at Silvasa and Pithampur (India) were put on the FDA Import Alert List this week, an outcome of Ipca running into problems in yet another FDA inspection. The latest alert comes after Ipca’s API facility in Ratlam (India) was banned from exporting to the U.S. in January this year. However, when reviewing the details of Ipca’s alert, is there a business opportunity which can be capitalized upon? The FDA Import Alert, while banning all imports from the Pithampur facility, has stopped everything coming out of the Silvasa plant except Hydroxychloroquine Sulfate & Propranolol Hydrochloride. Ipca’s Ratlam facility had received a similar exemption earlier for the following APIs: Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide. Given all the details that have been published about the observations at Ipca’s various facilities, a complete shutdown of all imports into the U.S. would have been expected. Why did a few of Ipca’s products get an FDA import alert exemption? Business Standard reported, at the time of covering the initial Ratlam ban that “Given the acute shortage in the US, the FDA, however, has exempted four APIs from the import ban.” The article also mentions the market growth of Hydroxychloroquine from $30 million to $120 million in the last few years. While the FDA hasn’t yet put Hydroxychloroquine on their drug shortage list, concerns regarding supply disruption are already being felt. Wyeth’s branded Propranolol Hydrochloride was a $215 million product in 2006, before intense generic competition reduced the market to about 10% of its original size in less than two years. While almost every major generic company has some variant of Propranolol Hydrochloride on the market, the number of API suppliers are extremely limited. Pharma Compass’ database shows that as Ipca, Albemarle (USA) and Cosmo Spa (Italy) are the only active Drug Master Files in the FDA database, capacity expansion constraints in Europe and United States could provide an opportunity for compliant API manufacturing of Propranolol Hydrochloride. With API manufacturers looking for new horizons, Ipca’s exemptions of old products like Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide should provide an manufacturing and marketing opportunity worth examining. Search our database for Sulfamethoxazole, Trimethoprim, Ondansetron, Hydroxychloroquine Sulfate, Propranolol Hydrochloride and Furosemide to study the competitive landscape of manufacturers, pricing information and a lot more.

Impressions: 4259

Excel Download

#Phispers by PHARMACOMPASS

27 Mar 2015

Find PharmaFlow Article for Furosemide

Furosemide

Furosemide

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

38 API Suppliers

20 USDMF

9 CEP/COS

5 JDMF

4 EU WC

17 NDC API

22 Listed Suppliers

DEVELOPMENTS

18 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Formulations

327 Dossiers

93 FDA Orange Book

103 Europe

26 Canada

27 Australia

37 South Africa

41 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 20MG

TABLET;ORAL - 40MG

TABLET;ORAL - 80MG

INJECTABLE;INJECTION - 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers

26 Roquette

25 Kerry

17 BASF

13 Microlex e.U

11 Sigachi Industries

9 Gangwal Healthcare

6 Actylis

6 DFE Pharma

6 Gangwal Chemicals

6 SPI Pharma

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Nanjing Well Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

3 Pharmatrans-Sanaq

3 Ingredion Pharma Solutions

3 Prachin Chemical

3 Vasa Pharmachem

2 Ulanqab Kema New Material

2 DKSH

1 Shijiazhuang Huaxu Pharmaceutical

1 Shanghai Welltone Material Technology Co., Ltd

1 Finar

1 Zhejiang Huakang Pharmaceutical

1 Ideal Cures Pvt Ltd

1 Aeon Procare

1 Rochem International Inc

1 Seppic

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders

30 Direct Compression

21 Disintegrants & Superdisintegrants

19 Lubricants & Glidants

19 Granulation

15 Thickeners and Stabilizers

14 Film Formers & Plasticizers

13 Co-Processed Excipients

12 Coating Systems & Additives

12 Parenteral

11 Controlled & Modified Release

11 Taste Masking

9 Solubilizers

7 Chewable & Orodispersible Aids

5 Topical

INJECTABLE;INJECTION - 10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons