Seqens Seqens

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    Find PharmaFlow Article for Clindamycin Phosphate

    Client Email Product

    Clindamycin Phosphate

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Formulations

    DRUG PRODUCT COMPOSITION

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS

    ANALYTICAL SOLUTION(s)

    DIGITAL CONTENT

    PharmaCompass
    Related ProductsRelated Products
    API SUPPLIERS
    API Suppliers

    API Suppliers

    36
    US DMFs Filed

    US DMFs Filed

    19
    CEP/COS Certifications

    CEP/COS Certifications

    11
    JDMFs Filed

    JDMFs Filed

    6
    Other Certificates

    Other Certificates

    1
    Other Suppliers

    Other Suppliers

    18
    API REF. PRICE (USD / KG)
    150

    API Market Place

    30
    INTERMEDIATES
    1
    DOSSIERS // FDF
    USA (Orange Book)

    USA (Orange Book)

    132
    Europe

    Europe

    9
    Canada

    Canada

    15
    Australia

    Australia

    0

    South Africa

    South Africa

    1
    Uploaded Dossiers

    Uploaded Dossiers

    7
    GLOBAL SALES (USD Million)

    U.S. Medicaid

    248.00

    Annual Reports

    0

    FDF Market Place

    4
    EXCIPIENTS
    106
    PATENTS & EXCLUSIVITIES

    USFDA Orange Book Patents

    23

    USFDA Exclusivities

    3
    DIGITAL CONTENT

    Blog #PharmaFlow

    2

    News

    52
    REF STANDARD

    EDQM

    3

    USP

    1

    JP

    0

    Other Listed Suppliers

    2
    SERVICES

    0

    left grey arrow
    right gray arrow
    • SOLUTION;INTRAVENOUS - EQ 300MG BASE/50ML (EQ 6MG BASE/ML)
    • SOLUTION;INTRAVENOUS - EQ 600MG BASE/50ML (EQ 12MG BASE/ML)
    • SOLUTION;INTRAVENOUS - EQ 900MG BASE/50ML (EQ 18MG BASE/ML)
    • INJECTABLE;INJECTION - EQ 150MG BASE/ML
    • SOLUTION;TOPICAL - EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • LOTION;TOPICAL - EQ 1% BASE
    • GEL;TOPICAL - EQ 1% BASE
    • GEL;TOPICAL - 5%;1.2%
    • GEL;TOPICAL - 5%;EQ 1% BASE
    • SUPPOSITORY;VAGINAL - 100MG
    • GEL;TOPICAL - EQ 1% BASE
    • CREAM;VAGINAL - EQ 2% BASE
    • AEROSOL, FOAM;TOPICAL - 1%
    • GEL;TOPICAL - 1.2%;0.025%
    BlogBlog
    Full View ScreenFull Screen View
    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal

    This week, Phispers brings to you the details of the bioelectronics firm formed by GSK and Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli Lilly, besides two other news snippets pertaining to the FDA -- while the first one pertains to generic approvals, the other one relates to an additional black box warning on a few antibiotics.   GSK and Google join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life Sciences and GSK will together contribute US $ 715.12 million over seven years to the startup Galvani Bioelectronics. The startup will develop miniature electronic implants for the treatment of asthma, diabetes and other chronic conditions. The implantable devices developed by Galvani, which is owned 55 percent by GSK and 45 percent by Verily, can modify electrical nerve signals. The aim is to modulate irregular or altered impulses that occur in many illnesses.The new company will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK has been working on bioelectronic medicines since 2012 in a push to develop new patentable treatments, since its Advair respiratory treatment faces competition from generic versions. It has invested US $50 million in a venture capital fund for bioelectronics and provided funding to scientists working in the field.  Teva divests 79 products to 11 generic players to close Allergan dealTeva Pharmaceutical Industries – the world’s largest generics drug company – won a US anti-trust approval to purchase Allergan's generics business, after agreeing to divest 79 generic drugs to rival firms. This was arrived at to settle Federal Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The companies that have acquired the divested products are Mayne Pharma Group, Impax Laboratories, Dr Reddy’s Laboratories, Sagent Pharmaceuticals, Cipla Limited, Zydus Worldwide DMCC, Mikah Pharma, Perrigo Pharma International, Aurobindo Pharma USA, Prasco and 3M Company. Eli Lilly CEO steps down; company under probe by US Justice Department Eli Lilly CEO John Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter has been the company's CEO since April 1, 2008, and the chairman of its board of directors since January 1, 2009.The announcement has come at a time when Eli Lilly has been asked by the Justice Department to disclose information on relationships with pharmacy benefits managers (PBMs), the companies that negotiate prices and set reimbursement conditions.It has not been clear what exactly the department of justice is looking for. In the past, drug makers such as Novartis and AstraZeneca have agreed to pay fines and penalties to settle allegations pertaining to PBMs.  FDA continues to race ahead with generic approvals  The American regulator has reduced its pile of ANDA (abbreviated new drug applications) by about 500 applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This news comes after Bloomberg reported last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass had reported last week that Indian companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark  In regulatory news from across the world, Jinan Jinda, a Chinese API manufacturer that had failed an inspection by Italian regulators in June 2015, had more bad news awaiting it a year on. In a June 2016 re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In the June 2015 inspection, the critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall.Meanwhile, the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements.  Another black box warning added to antibiotics like Cipro and LevaquinThe FDA has upgraded warnings on certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck’s Avelox. The FDA had added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed. In May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has said it plans to build a new pipeline of drugs. It plans to revamp its research operations at the cost of around US $ 727 million..  The company also plans to close some of its R&D operations in the UK. Takeda is beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement. 

    Impressions: 2756

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/gsk-google-form-first-bioelectronics-firm-11-generic-companies-benefit-from-the-teva-allergan-deal

    #Phispers by PHARMACOMPASS
    04 Aug 2016
    Share Share
    Data integrity has no relationship with product quality

    Data integrity has no relationship with product quality

    Peter J. Werth, President and Chief Executive Officer, ChemWerth, a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company providing cGMP quality APIs to the regulated markets, is a proponent of removing data to a data-integrity (DI) file from data history, if it isn’t linked to product quality. According to Werth, FDA is unnecessarily obsessed with data integrity issues, and pharma companies have begun to fear FDA inspections. This needs to change, Werth tells PharmaCompass. Excerpts from the interview.    Can you tell us about your journey in the world of pharmaceuticals? I began by supplying generic cough and cold APIs by setting up a chemical business back in 1975. There was a small group of companies (first generic companies) that mainly sold cough and cold products. These companies wanted to sell patent-expired generics and we developed select APIs for them. There was no real FDA (US Food and Drug Administration) approval process involved.  By 1982, I realized the generic industry would be big business and API sourcing was key to success. Since I knew the API business, my wife and I formed ChemWerth – a company that supplied generic APIs. By 1988, ChemWerth was working with 10 American and three Chinese manufacturers. But the generic scandal changed everything. My American partner factories gave up the API business when new regulations came in. Chemical plants could no longer manufacture APIs. From my previous 11 years of dealing with China, I knew that almost all of the dosage form factories also produced APIs. This was especially important for the injectable grade products. By the early 1990s, ChemWerth was developing APIs for highly toxic oncology injection drugs and many antibiotics. We successfully introduced doxorubicin, daunorubicin, mitomycin, bleomycin, etoposide, ifosfamide and several antibiotics such as lincomycin, clindamycin phosphate, amikacin sulfate, tobramycin and vancomycin (all from China). Today, ChemWerth represents 25 Chinese factories for about 100 products. We still represent one American API supplier along with several Indian manufacturers. We recently expanded to supply veterinary drugs and partnered with a major supplier of polypeptides and a world-class supplier of heparin and related products.     You have been working with China for many years now. When did you first come to China and how has the Chinese pharmaceutical industry transformed over the years? I first went to China in 1979. During that trip, I realized I could successfully deal with the Chinese. Most of my friends who went to China said it was impossible to deal with them. I always thought this gave me an advantage in China. Over the next seven years, I kept in touch with China, but did very little business.  In 1986, I was running ChemWerth and was a consultant with a company to help its large pharmaceutical facility produce generic APIs. We targeted clindamycin phosphate for development, since the product had good sales, and was off patent. It also had no competition because Upjohn (an erstwhile US-headquartered pharma company that got merged with Pharmacia in 1995, which in turn got bought over by Pfizer) controlled all the key starting material – lincomycin hydrochloride. Using my contacts and my ability to deal with Chinese factory directors, I managed to break Upjohn’s stronghold in lincomycin. I convinced three factories to work with me so that I could file a DMF (Drug Master File). Clindamycin became a very good product for ChemWerth and gave me reason to visit China regularly to develop new business. In those days, factories were generally old and needed upgradation. Documentation was always good, and in detail. However, it was mostly in codes and therefore useless to most others. It was extremely difficult to convince the factory to provide a true and detailed process to ChemWerth to file a DMF with the FDA. There is still a tendency (amid factories in China) to hide important facts. As a result, it takes ChemWerth at least three versions/iterations before we think we have got the right process details. Today, the hardware in China’s pharmaceutical factories is excellent, and is usually purchased from the best overseas manufacturer.  The software is good too and is likely to improve drastically as manufacturers realize software is equally important as hardware.    In view of the current GMP concerns being uncovered at Chinese companies, are you still focused on China as a source of pharmaceuticals? In my mind, and in the ChemWerth representative factories, there are no GMP concerns, no quality concerns, and no data history concerns. The FDA's fascination with data integrity focuses on a problem that does not exist in more than 90 percent of the pharmaceutical factories. There are at least 18 reasons to remove data from data history. All of these 18 reasons are related to analyst error and equipment failures (laboratory gross errors) and not related to quality or GMP manufacturing. (Click here to read Werth’s 18 reasons to remove data). I agree that gross errors/laboratory gross errors should not be deleted. I also agree that deleted gross errors/laboratory errors not related to quality do not deserve a warning letter. However, the FDA should also know the main reason data is deleted is because the analyst (often) knows the result is not correct for reasons not related to quality (gross errors/laboratory gross errors). They do not want to conduct an expensive, time-consuming, and cumbersome OOS (out-of-specification) investigation. Therefore, they delete the data, weigh out new samples, fix the problem, analyze, and either receive acceptable results or rejection results. Today, China has the most modern manufacturing facilities and the money to invest in software to manufacture the highest quality with the best traceable records. The Chinese need to trust the FDA to treat them fairly and not rely on two and three-year-old DI information. They will do the job correctly now and in future. But they cannot change the past. As stated earlier, all DI product-related observations have proven that the product quality and product history were acceptable. China can only become a stronger API supplier. China’s volumes will increase and costs will decrease, because the domestic market is growing rapidly. The country will have cost/pricing pressures and will need to concentrate more on the difficult products that require expensive equipment. The standards set by the China FDA (CFDA) match the US FDA standards. And this will make it easier to operate under one quality and documentation system. Most importantly, they have the money to invest in the latest technology, best scientists, and equipment.    In your view, what can pharmaceutical regulators and the industry do differently in order to communicate that the product quality is not at risk, given the environment where data-integrity violations have become commonplace? The FDA needs to understand that DI has no relationship with product quality. We have two recent examples. In the first case, DI issues applied to 70 batches. All 70 batches were retested and all were found to be in specification. The second case gave the same results – between two inspections over 100 batches were considered potentially fraudulent. All 100 batches were retested and were found to meet the specification. At both the factories, the data history showed all the batches are in specification – this implies 100 percent correlation to quality. The data integrity listed 100 batches and no batch failed specification – this shows 0 percent correlation to quality. From a DI perspective, FDA inspections in factories that only produce APIs for export should be different from inspections in pharmaceutical companies that export APIs and dosage form. In reality, API manufacturers cannot cheat. They sell their product to dosage form manufacturers, which in turn are responsible for the quality that goes into the dosage form. Off specification batches will be rejected and returned to the API manufacturer. While inspecting factories’ customer complaint file, it is rare to find batches being rejected and returned to the factory. The same does not apply to pharmaceutical companies that produce both API and finished dosage. They can hide information. Data integrity is more of an issue with companies that manufacture both API and dosage form.     What steps is ChemWerth taking with its partners in China to improve compliance standards? ChemWerth is addressing this issue with the FDA and ChemWerth representative factories. In broad terms, data history should be paramount, since it is related to product quality. Data integrity is a part of data history. ChemWerth has prepared a standard operating procedure (SOP) to handle electronic data.(Click here to read ChemWerth’s SOP). A simple version is that when one or both samples are out-of-specification, the analyst’s supervisor (who committed the error) reviews the data with the analysts. If they determine that one of the 18 reasons for analyst error or equipment failure is the cause of the failure, then this is noted. Three new samples are prepared, the error is corrected, and the samples are run and if all samples pass then these results are retained in data history and the product is passed. The previous bad result is documented and removed to the data integrity file. No lengthy, time-consuming, and expensive OOS report is conducted. This makes the procedure factory-friendly. In the above example, if one of the three new samples fails, then all results are retained in the data history. The batch is rejected for rework or reprocessing. I believe the present atmosphere between the FDA and API manufacturers is at an all-time low. The industry feels the FDA inspectors are looking at mostly irrelevant data to prove that the factory operates fraudulently. Factories no longer welcome FDA inspections, out of fear of DI failure. Factories feel the FDA is using DI to point out fraud where there is none (excluding Hisun and Ranbaxy). In the past, we always welcomed FDA inspections as part of doing business. We need to get back to that time and place.  

    Impressions: 6143

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/data-integrity-has-no-relationship-with-product-quality

    #Phispers by PHARMACOMPASS
    07 Jul 2016
    Share Share
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty
    Rochem Clindamycin Phosphate

    Access Virtual Booth

    Contact Supplier

    View Presentation

    veranova-m-2024-04-22

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Post Enquiry
    POST ENQUIRY

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search