Tramadol Hydrochloride

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

82 API Suppliers, 36 USDMF, 27 CEP/COS, 7 JDMF, 17 EU WC, 66 KDMF, 23 NDC API, 43 Listed Suppliers

DEVELOPMENTS

15 Drug(s) in Development

15 Drug(s) in Development

PRICE INFORMATION

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

INTERMEDIATES

2 Suppliers

2 Suppliers

DOSSIERs // Finished Dosage Formulations

742 Dossiers, 78 FDA Orange Book, 405 Europe, 35 Canada, 50 Australia, 48 South Africa, 126 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 325MG;37.5MG
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 150MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

Suppliers, 39 Kerry, 34 BASF, 22 Roquette, 17 SPI Pharma, 17 Microlex e.U, 16 Seppic, 12 Sigachi Industries, 12 Gangwal Healthcare, 12 Gangwal Chemicals, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 Corel Pharma Chem, 10 Nanjing Well Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 7 DFE Pharma, 7 Ideal Cures Pvt Ltd, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 6 Lonza Capsugel, 5 Actylis, 5 Prachin Chemical, 5 Pharmatrans-Sanaq, 5 Ingredion Pharma Solutions, 4 Ulanqab Kema New Material, 4 Kima Chemical, 4 Vasa Pharmachem, 4 ACG Worldwide, 3 The Dow Chemical Company, 3 Jai Radhe Sales, 3 Clariant, 2 Nomisma Healthcare, 2 Seqens, 2 Finar, 2 Shanghai Welltone Material Technology Co., Ltd, 2 Qualicaps, 2 DKSH, 2 Rochem International Inc, 2 Alcedo Pharmachem, 1 Nanjing Bold Chemical, 1 Minakem, 1 Vertellus, 1 Avesta Pharma, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Aeon Procare, 1 Shijiazhuang Huaxu Pharmaceutical, 1 NEWEDGE Overseas, 1 Pharm-RX Chemical, 1 Chynops Pharma, 1 Pfanstiehl

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93 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 46 Direct Compression, 35 Controlled & Modified Release, 33 Solubilizers, 32 Granulation, 30 Thickeners and Stabilizers, 29 Lubricants & Glidants, 24 Topical, 22 Parenteral, 22 Film Formers & Plasticizers, 19 Chewable & Orodispersible Aids, 19 Taste Masking, 18 Co-Processed Excipients, 9 Empty Capsules, 9 API Stability Enhancers, 8 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

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32 US Medicaid Prescriptions, 375 Finished Drug Prices

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54 APIs, 27 DOSSIERS // FDF

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9 US Patents, 1 US Exclusivities, 12 Health Canada Patents

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2 BioAnalytical Methods, 3 EDQM Standards, 1 USP Standards, 6 Other Ref. Standards

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3 Data Compilations & Company Tracker #PharmaFlow, 61 News

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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

Dr. Reddy’s faces penalties in the US; metformin found in American waters; Interpol seizes illicit medicines

This week, Phispers brings to you the latest news from the world of pharma where Merck was found lying under oath, Mylan’s “exceptionally large” drug price hikes reignited the price-gouging debate and data integrity issues surfaced in China. And, a lot more.Dr. Reddy’s acquires products from Teva; but faces penalties in the USThis has been a mixed week for Dr. Reddy’s Laboratories. The company has signed a deal with Israeli drug maker Teva to acquire a portfolio of eight abbreviated new drug applications (ANDAs) in the US for US $ 350 million. In April 2015, Teva had entered into a deal with Allergan to buy its generics products for US $ 40.5 billion, soon after it failed in its bid to buy Mylan. On the flip side, the US Consumer Product Safety Commission (CPSC) has sought civil penalties against Dr. Reddy’s for failing to report problems with packaging of several medicines. In a 4-1 vote held two weeks ago, CPSC said Dr. Reddy’s knowingly violated federal law as issues with child-resistant blister packs for five prescription drugs were not reported within the mandated 24 hours. The violations had occurred between 2002 and 2011. After antibiotics in Chinese rivers, it’s metformin in American watersIn June last year, we reported on how antibiotics were found in the rivers of China. This week, a new study has found traces of the widely-used diabetes drug – metformin – and other medicines in dozens of streams throughout southeastern United States. The survey was done on 59 streams and it found an average of six different drugs. The findings suggest the cause of contamination was unrelated to discharges from wastewater treatment facilities. Metformin appeared in 89 percent of the samples and 97 percent of the sample sites. Researchers also found traces of tramadol (opioid); carbamazepine (anti-seizure drug) and Allegra (antihistamine). At some of the sample sites, the concentrations of these medicines are expected to affect aquatic life. There was also some good news about metformin this week. Research has suggested that metformin may exert a long-term protective effect against neurodegenerative diseases, including Alzheimer's and Parkinson's. Court overturns US $ 200 million jury award; says Merck ‘lied under oath’A federal judge in San Jose found Merck lied to a business partner and to the court. As a result, the judge threw out a patent infringement judgment Merck had won against Gilead Sciences. He also overturned a US $ 200-million jury award. This judgement is considered a landmark one, considering it involves Gilead’s blockbuster drug Sovaldi, a treatment for the hepatitis C virus, and Merck – the world’s fourth-largest drug company. “Merck's misconduct includes...misusing Pharmasset's confidential information..., and lying under oath at deposition and trial,” the federal judge, Beth Labson Freeman, said. This news comes at a time when a review by the US Food and Drug Administration (FDA) staffers questioned whether an experimental Merck drug is effective in treating Clostridium difficile, or C. difficile, the most common cause of infectious diarrhea in hospitals and nursing homes. Mylan’s ‘exceptionally large’ drug price rise brings pricing debate back in focusPrice gouging has been plaguing the global pharma industry for quite some time now. During the week, there was news about Mylan and Pfizer increasing prices. Over the last six months, Mylan has raised prices by more than 20 percent on 24 products. Meanwhile, Pfizer was in news for increasing the list prices of its medicines in the US by an average of 8.8 percent. This is the second time this year that Pfizer has substantially boosted prices for its prescription drugs. On January 1, Pfizer had raised prices by an average of 10.4 percent. Mylan boosted prices by more that 100 percent on seven other products. Wells Fargo analyst David Maris termed the price hikes as “exceptionally large.” In Europe, the high price of drugs is straining its cash-strapped health systems and depriving patients of the latest products. Ergo, the European pharmaceutical industry is considering a radical shift in the way it prices drugs so that companies are rewarded for the clinical benefit of treatments rather than the number of pills sold. An internal report prepared by the European Federation of Pharmaceutical Industries and Association has called for the removal of external reference pricing and placing curbs on parallel imports. Interpol’s Operation Pangea IX seizes US $ 53 million worth of illicit medicinesInterpol seized potentially life-threating drugs and goods, including fake cancer medication, substandard HIV and diabetes testing kits, counterfeit dental equipment and illicit surgical equipment, through its Operation Pangea IX. The operation involved targeting illicit online sale of medicines and medical devices. It involved 193 police, customs and health regulatory authorities from 103 countries. Operation Pangea resulted in 393 arrests worldwide and the seizure of more than US $ 53 million worth of potentially dangerous medicines. The operation was supported by private partners from the Internet and payment industries and saw the suspension of 4,932 websites selling illicit pharmaceuticals. India’s pharma industry growth dips to two-year lowThe impact of Indian health ministry’s gazette notification banning the immediate manufacture, sale and distribution of 344 fixed dose combination (FDC) drugs has begun to reflect in growth numbers. The Indian pharmaceuticals market’s growth this May was the lowest in two years, impacted by a drop in sales of FDC drugs, fresh price cuts and a lower than expected uptake, according to pharmaceutical market research company AIOCD PharmaTrack. For May, the pharmaceuticals market grew by 7.7 percent compared to 11.6 percent during the same month last year, reaching sales of Rs 994.76 billion (US $ 14.8 billion) over a 12-month period. India’s FDC market dropped 14.6 percent and is now valued at Rs 1.96 billion (US $ 29.1 million). Valeant may sell stake in Egypt’s largest drug company AmounValeant Pharmaceuticals International plans to step up its debt-reduction plans and is considering the sale of Egyptian drug maker Amoun Pharmaceutical. According to a report, Amoun may attract drug companies with an interest in expanding in emerging markets. Valeant is reportedly working with Goldman Sachs Group on the sale. Last year, Valeant had acquired Amoun’s holding company – Mercury Holdings – for around US $ 800 million, along with some contingent payments. Valeant’s intentions at the time were to use Amoun as a platform to further expand in the Middle East and Africa. GMP problems roundup: Fresh cases emerge in China, India Beijing Taiyang Pharmaceutical Industry, a Chinese manufacturer of diphenyhydramine hydrochloride, a commonly used antihistamine, was placed on the FDA import alert list in April 2016. Last week, Beijing Taiyang was also placed on Health Canada’s Inspection Tracker List as the regulatory agency evaluated the risk the company’s products posed to patients. The primary reason given for the action was data integrity concerns. Akums Drugs & Pharmaceutical Limited is a major Indian contract manufacturer with nine facilities that mostly supply to the domestic market. Akums’ international expansion plans suffered a setback as its facility in Haridwar (India) failed its first EDQM (European Directorate for the Quality of Medicines & HealthCare) inspection. The critical deficiency observed by the inspectors was the “lack of sterility assurance as there was insufficient evidence during validation to confirm that all ampoules in the load met the sterilizing conditions”. There were also deficiencies observed across all aspects of the quality management system. Akums’ failure is a setback for the Netherlands-based Nordic Pharma Limited for whom Akums was manufacturing progesterone injection 50mg/mL ampoules (Gestone). The inspection failure will result in the recall of four batches from the UK and Ireland and will most likely have Nordic Pharma retain their existing contract manufacturer, Hikma Italia SPA.

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16 Jun 2016

Will data integrity concerns on clinical trials done at GVK Biosciences go beyond Europe?

Over 700 commonly used generic medicines were recommended for suspension by the European Medicines Agency (EMA) based on data integrity concerns, over clinical studies conducted at GVK Biosciences in Hyderabad, India.What will be the global fallout of the European decision? The European decision has impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The original recommendation of suspending some of the medicines made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization- CRO) by the French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site.” 1000 drugs reviewed// 700 rejectedWhile over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site, over 300 of them had sufficient supporting data available from other sources. As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation will now be sent to the European Commission for a legally binding decision, which will apply to Member States regardless of the decision taken in the interim period.The updated list of medicines for which, the CHMP (Committee for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies are given 12 months to submit additional data. The potential global impact of the European suspensions?The GVK Biosciences scandal is almost as severe in magnitude and impact, as the data falsification concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity violations, which bankrupted clinical research organization, Cetero Research/PRACS. Based on the Cetero findings in the United States, the EMA suspended seven drugs. Now it remains to be seen, how the FDA will handle the data integrity concerns found in Europe since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals. Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS case”.It’s clear for us that this is not the end of the story…

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28 May 2015

Find PharmaFlow Article for Tramadol Hydrochloride

Tramadol Hydrochloride

Tramadol Hydrochloride

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

82 API Suppliers

36 USDMF

27 CEP/COS

7 JDMF

17 EU WC

66 KDMF

23 NDC API

43 Listed Suppliers

DEVELOPMENTS

15 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

2 Suppliers

DOSSIERs // Finished Dosage Formulations

742 Dossiers

78 FDA Orange Book

405 Europe

35 Canada

50 Australia

48 South Africa

126 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 325MG;37.5MG

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 100MG

CAPSULE, EXTENDED RELEASE;ORAL - 150MG

CAPSULE, EXTENDED RELEASE;ORAL - 200MG

CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

Suppliers

39 Kerry

34 BASF

22 Roquette

17 SPI Pharma

17 Microlex e.U

16 Seppic

12 Sigachi Industries

12 Gangwal Healthcare

12 Gangwal Chemicals

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

11 Corel Pharma Chem

10 Nanjing Well Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

7 DFE Pharma

7 Ideal Cures Pvt Ltd

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

6 Lonza Capsugel

5 Actylis

5 Prachin Chemical

5 Pharmatrans-Sanaq

5 Ingredion Pharma Solutions

4 Ulanqab Kema New Material

4 Kima Chemical

4 Vasa Pharmachem

4 ACG Worldwide

3 The Dow Chemical Company

3 Jai Radhe Sales

3 Clariant

2 Nomisma Healthcare

2 Seqens

2 Finar

2 Shanghai Welltone Material Technology Co., Ltd

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons