Prestwick3_000358

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

28 API Suppliers, 21 USDMF, 4 JDMF, 1 EU WC, 5 NDC API, 5 Listed Suppliers

PRICE INFORMATION

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

INTERMEDIATES

3 Suppliers

3 Suppliers

DOSSIERs // Finished Dosage Formulations

153 Dossiers, 93 FDA Orange Book, 6 Europe, 6 Canada, 2 South Africa, 46 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 26 Kerry, 23 Roquette, 13 Microlex e.U, 12 Sigachi Industries, 9 Gangwal Healthcare, 9 BASF, 9 Gangwal Chemicals, 8 Seppic, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 DFE Pharma, 6 Actylis, 6 SPI Pharma, 5 Nanjing Well Pharmaceutical, 4 Rochem International Inc, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Ingredion Pharma Solutions, 4 Prachin Chemical, 4 Vasa Pharmachem, 4 ACG Worldwide, 3 Lonza Capsugel, 3 DKSH, 2 Pharmatrans-Sanaq, 2 Finar, 2 Jai Radhe Sales, 1 The Dow Chemical Company, 1 Clariant, 1 Nanjing Bold Chemical, 1 Pharm-RX Chemical, 1 Kima Chemical, 1 Ideal Cures Pvt Ltd, 1 Pfanstiehl, 1 Aeon Procare, 1 Qualicaps

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 30 Direct Compression, 29 Disintegrants & Superdisintegrants, 23 Thickeners and Stabilizers, 18 Granulation, 17 Solubilizers, 16 Coating Systems & Additives, 15 Lubricants & Glidants, 15 Taste Masking, 13 Co-Processed Excipients, 11 Topical, 9 Parenteral, 9 Film Formers & Plasticizers, 8 Controlled & Modified Release, 8 Empty Capsules, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 5 Emulsifying Agents, 3 Surfactant & Foaming Agents, 3 API Stability Enhancers

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 12 Finished Drug Prices

MARKET PLACE

14 APIs, 4 DOSSIERS // FDF

ANALYTICAL SOLUTION(s)

2 USP Standards, 10 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilations & Company Tracker #PharmaFlow, 16 News

Blog

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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

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05 Jul 2018

EU suspends drugs from Granules’ Indian facility where FDA had no concerns

In October 2016, the US Food and Drug Administration (FDA) inspected a facility in India belonging to Granules India that manufactures pharmaceutical formulation intermediates (PFIs) and finished dosage forms (FDFs). The FDA had no observations. Three months later, Portugal’s health authority — INFARMED — inspected the same site and detected non-conformities in good manufacturing practices (GMPs). According to an alert published on the INFARMED website, the observations were related to granulation and primary packaging of tablets in batches of drugs related to paracetamol and metformin supplied by Granules to Mylan, Bluepharma and Sandoz. The agency recommended the suspension and recall of certain batches from the market in Portugal. Last week, based on “General GMP Observations” of “regulatory partner(s)”, Health Canada placed Granules India’s facility located in Gagillapur (near Hyderabad) on its inspection tracker. Health Canada’s inspection tracker provides updates on the actions the regulator is undertaking to assess and manage potential risks arising from inspections of drug manufacturing facilities. According to Granules, their facility in Gagillapur contributes over 50 percent to their revenues and “has the world’s largest PFI capacity along with an industry-leading batch size of six tons. In addition, the Gagillapur facility has one of the largest single-site finished dosage capacities in the world for their respective products.” In a recent interview, C. Krishna Prasad, managing director of Granules India, said there were no issues related to data integrity and INFARMED is scheduled to re-inspect the Gagillapur facility this week. Data integrity concerns at ACS Dobfar’s Italian facility The FDA’s April 2016 inspection of ACS Dobfar’s operations in Brazil — Antibioticos do Brasil (ABL) — led to the issuance of a warning letter in December. Among other observations, the FDA investigators found that the filling zone for sterile injectable product was not sufficiently robust. Therefore, it didn’t protect the drugs being manufactured there (such as during the times when operators entered the final filling area). Almost immediately after the warning letter was issued, an inspection of the same facility by the Italian Regulatory Agency (AIFA) found it not-compliant for the manufacture of the active ingredient — Cephalexin Sodium Sterile. AIFA also recommended the suspension of the Certificate of Suitability issued for ceftazidime pentahydrate with sodium carbonate for injection. The inspectors found ABL failed to ensure a good level of maintenance and cleaning of the final crystallization area and there was a poor level of training, low knowledge and awareness of good manufacturing practices (GMP) along with lack of supervisory control. The non-compliance report also mentions that some non-authorized and fraudulent activities were stopped before inspectors entered certain manufacturing areas. Fraudulent activities were not limited to Brazil, as ACS Dobfar’s Italian drug manufacturing facility — FACTA Farmaceutici SpA — had FDA investigators uncover data-integrity violations during a January 2016 inspection. The warning letter issued to FACTA mentions that for multiple lots of sterile drug product, where the original data showed failing results, the data reportedly showed passing results. The company was found storing original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. The analyst told investigators that original data was first recorded in the “unofficial” spreadsheet and later transcribed to an “official” form. Investigators also observed many copies of uncontrolled blank and partially-completed cGMP forms and also documented that employees at FACTA used paper shredders to destroy critical laboratory and production records. It is worth mentioning that FACTA’s EU GMP certification was renewed by the Italian regulators after an inspection that was conducted at the same time as the FDA inspection. Data integrity concerns confirmed at Divi’s Laboratories in India Divi’s Laboratories’ Unit-II situated in Visakhapatnam, Andhra Pradesh — one of the biggest manufacturing facilities for the major producer of active pharmaceutical ingredients (APIs) — was inspected by the US FDA from November 29 to December 6, 2016. The regulators issued a Form 483 with five observations. While data integrity concerns had been widely reported in news media, Health Canada confirmed the violations by placing the company on its inspection tracker last week. FDA’s warning letter comes to haunt Dr. Reddy’s South Korean biotech firm — Mezzion Inc — filed a suit for damages against Dr. Reddy’s in New Jersey state court alleging that it hid “significant deficiencies in its FDA cGMP practices” and misrepresented its compliance. Mezzion has stated in its suit that “Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations” whereas the FDA issued a warning letter to Dr. Reddy's. During an FDA inspection at Dr. Reddy's facilities in India, the FDA identified numerous data integrity violations and also uncovered a previously unknown and uncontrolled “Custom QC laboratory” (CQC), which engaged in a “practice of substituting repeat tests after failing results.” Mezzion further states: “Dr. Reddy’s misconduct was the sole reason given by the FDA to deny approval of Mezzion’s new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED)”. As a result, Mezzion has incurred delays and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, in order to resubmit its udenafil New Drug Application (NDA) to the FDA for approval. FDA’s warning letters to manufacturers in UK and India Porton Biopharma, UK: A warning letter was issued to the UK-based Porton Biopharma by the US FDA for manufacturing violations related to Erwinaze (asparaginase Erwinia chrysanthemi) — an orphan biologic which was developed by Porton and licensed to Jazz Pharmaceuticals. According to the warning letter, the FDA had previously performed an inspection of Porton’s facility in January 2015 and found similar concerns. The inspection between March 7 and 18, 2016, which triggered the warning letter, had FDA investigators observe continued deficiencies, including metal particles which penetrated a few batches of Erwinaze, another batch containing paper or cardboard fibers and a possible microbial contamination. While Porton believed that vial stoppers were the source of the metal scraps, the FDA investigators were not convinced. Erwinaze generated around US $ 43 million in the third quarter for Jazz Pharmaceuticals, accounting for more than 10 percent of the company’s revenues. CTX Life Sciences, India: The FDA issued a warning letter to CTX Life Sciences in India after making observations of rust, insects, damaged interiors, and/or drug residues in pieces of manufacturing equipment identified as “clean”. Investigators also found that the API were released without testing because the necessary laboratory equipment was out of order. While the company had decided to release batches “on conditional basis and as soon as UV maintenance issue rectified analysis shall be performed” the investigators could find no trace of the testing. Our view Last week, in our compliance round up, we had reported the shredding of documents at Hetero Labs in India. And this week, similar issues have surfaced in Italy. It’s clear that corrupt practices of data integrity are spreading across the industry and are no longer confined to a region. At the same time, while both European and US regulators reached a similar outcome on the compliance status of Antibioticos do Brasil, the divergent views at Granules India and FACTA Farmaceutici indicate the urgency for regulators to establish a consistent global evaluation standard for pharmaceutical manufacturing.

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02 Feb 2017

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!

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05 Jan 2017

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

Find PharmaFlow Article for Prestwick3_000358

Prestwick3_000358

Prestwick3_000358

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

28 API Suppliers

21 USDMF

4 JDMF

1 EU WC

5 NDC API

5 Listed Suppliers

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

3 Suppliers

DOSSIERs // Finished Dosage Formulations

153 Dossiers

93 FDA Orange Book

6 Europe

6 Canada

2 South Africa

46 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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23 Roquette

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9 Gangwal Healthcare

9 BASF

9 Gangwal Chemicals

8 Seppic

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

7 DFE Pharma

6 Actylis

6 SPI Pharma

5 Nanjing Well Pharmaceutical

4 Rochem International Inc

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Ingredion Pharma Solutions

4 Prachin Chemical

4 Vasa Pharmachem

4 ACG Worldwide

3 Lonza Capsugel

3 DKSH

2 Pharmatrans-Sanaq

2 Finar

2 Jai Radhe Sales

1 The Dow Chemical Company

1 Clariant

1 Nanjing Bold Chemical

1 Pharm-RX Chemical

1 Kima Chemical

1 Ideal Cures Pvt Ltd

1 Pfanstiehl

1 Aeon Procare

1 Qualicaps

EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders

30 Direct Compression

29 Disintegrants & Superdisintegrants

23 Thickeners and Stabilizers

18 Granulation

17 Solubilizers

16 Coating Systems & Additives

15 Lubricants & Glidants

15 Taste Masking

13 Co-Processed Excipients

11 Topical

9 Parenteral

CAPSULE;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons