Bora CDMO Bora CDMO

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    Find PharmaFlow Article for Metoprolol Succinate

    Client Email Product

    Metoprolol Succinate

    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

    53
    US DMFs Filed

    US DMFs Filed

    34
    CEP/COS Certifications

    CEP/COS Certifications

    15
    JDMFs Filed

    JDMFs Filed

    0

    Other Certificates

    Other Certificates

    15
    Other Suppliers

    Other Suppliers

    26
    API REF. PRICE (USD / KG)
    55

    API Market Place

    7
    INTERMEDIATES
    5
    DOSSIERS // FDF
    USA (Orange Book)

    USA (Orange Book)

    91
    Europe

    Europe

    29
    Canada

    Canada

    0

    Australia

    Australia

    27
    South Africa

    South Africa

    0

    Uploaded Dossiers

    Uploaded Dossiers

    23
    GLOBAL SALES (USD Million)

    U.S. Medicaid

    5,424.00

    Annual Reports

    0

    FDF Market Place

    1
    EXCIPIENTS
    288
    PATENTS & EXCLUSIVITIES

    USFDA Orange Book Patents

    8

    USFDA Exclusivities

    0

    DIGITAL CONTENT

    Blog #PharmaFlow

    2

    News

    31
    REF STANDARD

    EDQM

    2

    USP

    1

    JP

    0

    Other Listed Suppliers

    1
    SERVICES

    0

    left grey arrow
    right gray arrow
    • TABLET, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 100MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 200MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 25MG TARTRATE
    • CAPSULE, EXTENDED RELEASE;ORAL - EQ 50MG TARTRATE
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    BlogBlog
    Full View ScreenFull Screen View
    Emcure’s Import Alert: Is there a way of knowing who will be next?

    Emcure’s Import Alert: Is there a way of knowing who will be next?

    The U.S. FDA banned drug imports from the finished dosage form operations of Emcure Pharmaceuticals Ltd over concerns related to their manufacturing practices. As our previous analysis, four months ago, “Quality Alerts at Lupin, Hospira, Emcure and Union Quimico Farmaceutica”, had anticipated the problems at Emcure, we were not at all surprised.Now that Emcure, a top 20 drug maker in India, joins the growing ranks of companies with compliance concerns, are there others who are likely to get cited next?  “Recalling” Emcure Emcure has been involved in multiple product recalls in recent times and while no warning letters have been posted yet, the reason for the product recalls were always, compliance concerns at Emcure. In February 2015, aseptic and GMP practices at Emcure’s operations had impacted product sterility and Emcure’s customer, Sagent Pharmaceuticals had to recall their Atracurium Besylate injections. At the same time, lack of assurance of product sterility was the reason cited by Heritage Pharmaceuticals (Emcure’s subsidiary in the U.S.) when they recalled their batches of Colistimethate & Rifampin injections. Last year, Teva was forced to recall almost 40,000 bottles of products manufactured at Emcure because "laboratory testing was not followed in accordance with GMP requirements."  A ban on $500 million Emcure will impact U.S. pharmaceuticals  Emcure's plant in Hinjawadi in Pune, India has three finished dosage form facilities which, in our assessment, are covered by the import alert. Emcure’s strength has been on producing injectable products and now it joins a growing list of sterile manufacturing plants where compliance is a concern. Concerns at sterile manufacturing operations of Hospira, Hikma Portugal, Bedford (which is now owned by Hikma) and others will make the import ban on Emcure have a significant impact on the US pharmaceutical market. It is hence not surprising that eight injectable products, made at Emcure, have been exempted from the import ban, a position usually taken by the FDA to prevent drug shortages. Privately held Emcure, with almost $500 million in sales and which counts private equity players like Bain Capital among its main investors, clearly has a tough road ahead.   Regulatory overhaul in IndiaIn order to revive the brand image of the pharmaceutical industry in India, the government is planning to take several measures, which includes the overhauling of CDSCO, the regulatory body for drug quality standards in India.With the Indian regulator planning to undertake a massive drug inspection exercise, there are chances that now, Indian companies will encounter many more domestic compliance challenges as well.  Warning Bells from the U.S.Last week, the FDA published the list of companies who have not paid their GDUFA facility fees. The GDUFA facility fee is paid annually by generic companies to continue to do business in the United States. Maybe it is time to wonder, why some companies are not paying the FDA? Especially since some on the list have made recent headlines due to problems in international regulatory inspections…While PharmaCompass covered the compliance issues at Polydrug Laboratories (India) & IDT Biologika (Germany) recently, there are others whose regulatory concerns are also available for review in the public domain.  Fleming Laboratories and Smruthi Organics, have been on the FDA Import Alert list for quite some time now and Sharon Bio-medicine was issued a non-compliance report by the EDQM in 2013. Additional warnings from across the borderWhile not on the GDUFA payment defaulter list, data integrity concerns at Chinese API manufacturer, Zhejiang Hisun have already made Health Canada issue a notice to voluntarily quarantine drugs, made or tested with API from Hisun. Health Canada’s decision was based on a “trusted regulatory partner” so it would not be surprising if we see similar action from other agencies.  Signs of European trouble In Europe, the EDQM has recently suspended some CEPs of European manufacturers like Polpharma (metoprolol tartrate & metoprolol succinate) and Synteco S.p.A (articaine hydrochloride & ropivacaine hydrochloride). A CEP suspension does not always result in a non-compliance report, however, there is a high degree of correlation between the two activities.   Our viewWhile compliance issues at some of the companies mentioned above have not yet made headlines, at PharmaCompass, we strive to collate the latest industry developments to provide actionable intelligence so that we can continue to be your “trusted information partner”.  After all, like Health Canada, using real-time information and taking a proactive approach towards compliance, will always ensure the health of patients and in turn generate better business. 

    Impressions: 4533

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/emcure-s-import-alert-is-there-a-way-of-knowing-who-will-be-next

    #Phispers by PHARMACOMPASS
    16 Jul 2015
    Share Share
    Dr. Reddy’s expansion plans for API production

    Dr. Reddy’s expansion plans for API production

    Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were   Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores  *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.   Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin  375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I  Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl  533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride  500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin  0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

    Impressions: 3087

    subscribeSubscribe
    ExcelExcel Download

    https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production

    #Phispers by PHARMACOMPASS
    03 Apr 2015
    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
    euroapi-m-2024-04-29

    Access Virtual Booth

    Contact Supplier

    View Presentation

    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

    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