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    Company profile for Merck & Co

    Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    xyz-pharma-m-2025-06-09

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    About

    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the compa...
    Our goal is to lead the way to a healthier future. But we also care about how we get there together. As a company whose products touch the lives and well being of people around the world, we hold ourselves to a high standard. And we expect others to hold us to that same high standard. We believe in operating openly, honestly and with the highest degree of ethics and integrity. This includes: making sure that the company complies with all applicable laws and regulations globally.

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    Merck & CoUnited_States_of_America Flag
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    U.S.A
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    One Merck Drive, P.O. Box 100 Whitehouse Station, NJ 08889-0100
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    +1 732 422 7800
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

    micAlchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

    With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

    Impressions: 1152

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    https://www.pharmacompass.com/speak-pharma/alchem-nicselect-grants-customers-royalty-free-access-to-t-max-tech-for-3-in-1-vape-satisfaction-in-flavour-restricted-markets

    Radio Compass
    06 May 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaProviding RSMs & API to Global Pharma CompaniesProviding RSMs & API to Global Pharma Companies

    Providing RSMs & API to Global Pharma Companies
    Providing RSMs & API to Global Pharma Companies

    reelProviding RSMs & API to Global Pharma Companies

    This PharmaReel showcases Allsino Pharmaceutical, a company that provides GMP-certified RSMs and APIs to global pharma companies, specializing in peptides, oligonucleotides, and small molecule CDMO services. Allsino has a presence in the US, EU, China and Japan.

    Impressions: 5

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

    The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits. 
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    Impressions: 1667

    https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-announces-restructuring-post-iff-pharma-buyout-who-fda-advance-regulatory-frameworks

    #PharmaFlow by PHARMACOMPASS
    29 May 2025
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    NEWS #PharmaBuzz

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    US FDA Approves Merck's RSV Antibody for Infants
    US FDA Approves Merck's RSV Antibody for Infants

    10 Jun 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-mercks-rsv-antibody-infants-2025-06-09/

    REUTERS
    10 Jun 2025
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    FDA limits Merck's Keytruda, BMS' Opdivo in Stomach Cancer
    FDA limits Merck's Keytruda, BMS' Opdivo in Stomach Cancer

    10 Jun 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/fda-limits-merck-keytruda-bristol-myers-opdivo-stomach-cancer

    FIERCE PHARMA
    10 Jun 2025
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    Merck's Cholesterol Drug Meets Main Goal in Two Studies
    Merck's Cholesterol Drug Meets Main Goal in Two Studies

    09 Jun 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-cholesterol-drug-meets-main-goal-late-stage-studies-2025-06-09/

    REUTERS
    09 Jun 2025
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    Merck made $3B offer for MoonLake & could revive interest
    Merck made $3B offer for MoonLake & could revive interest

    04 Jun 2025

    // FINANCIALTIMES

    https://www.ft.com/content/5899ea69-e5fe-49f1-8ada-79f26c9254d8

    FINANCIALTIMES
    04 Jun 2025
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    Merck to Join 46th Annual Goldman Sachs Healthcare Conference
    Merck to Join 46th Annual Goldman Sachs Healthcare Conference

    04 Jun 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250604404414/en/Merck-to-Participate-in-the-46th-Annual-Goldman-Sachs-Global-Healthcare-Conference

    BUSINESSWIRE
    04 Jun 2025
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    Arcus Kidney Cancer Drug Casdatifan Advances to Challenge Welireg
    Arcus Kidney Cancer Drug Casdatifan Advances to Challenge Welireg

    03 Jun 2025

    // BIOSPACE

    https://www.biospace.com/drug-development/arcus-kidney-cancer-drug-casdatifan-advances-to-challenge-mercks-welireg

    BIOSPACE
    03 Jun 2025
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Betamethasone

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Betamethasone

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12937

    Submission : 1998-04-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2017-092 - Rev 00

    Issue Date : 2022-12-12

    Type : Chemical

    Substance Number : 312

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Product
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    #PipelineProspector

    Market
    Place

    02

    Betamethasone

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Betamethasone

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-214 - Rev 00

    Issue Date : 2020-01-27

    Type : Chemical

    Substance Number : 312

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Betamethasone

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Betamethasone

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10129

    Registrant's Address : 50 Tuas West Drive Singapore 638408

    Initial Date of Registration : 2012-07-19

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    04

    Betamethasone Dipropionate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Betamethasone Dipropionate

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10865

    Registrant's Address : 50 Tuas West Drive Singapore 638408

    Initial Date of Registration : 2006-11-06

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Betamethasone Valerate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Betamethasone Valerate

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10825

    Registrant's Address : 50 Tuas West Drive Singapore 638408

    Initial Date of Registration : 2006-10-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
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    #PipelineProspector

    Market
    Place

    06

    Ivermectin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Ivermectin

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-146 - Rev 01

    Issue Date : 2008-11-27

    Type : Chemical

    Substance Number : 1336

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Inactive-api
    ✖

    VMF Number : 5476

    Submission : 1993-10-22

    Status : Inactive

    Type : II

     Others AUDIT
    blank

    Product
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    #PipelineProspector

    Market
    Place

    07

    Loratadine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Loratadine

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-218 - Rev 00

    Issue Date : 2013-12-19

    Type : Chemical

    Substance Number : 2124

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Korea MSD Co., Ltd.

    Registration Date : 2009-09-24

    Registration Number : 20090924-6-C-263-06

    Manufacturer Name : Schering-Plough (Avondale) Co

    Manufacturer Address : Rathdrum Co. Wicklow

     VMF Others AUDIT
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    Market
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    08

    Mometasone Furoate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Mometasone Furoate

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10890

    Registrant's Address : 50 Tuas West Drive Singapore 638408

    Initial Date of Registration : 2006-11-10

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Montelukast Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Montelukast Sodium

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10593

    Registrant's Address : Ballydine, Kilsheelan, Clonmel, Co. Tipperary, Ireland

    Initial Date of Registration : 2005-09-14

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    10

    Sitagliptin Phosphate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    FCE Pharma
    Not Confirmed
    arrow

    Sitagliptin Phosphate

    Singapore

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    FCE Pharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10105

    Registrant's Address : 50 Tuas West Drive Singapore 638408

    Initial Date of Registration : 2023-08-30

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
    blank

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    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    FDF Dossiers

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    01

    Brand Name : Vaxneuvance

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Vaxneuvance

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    15-valent Pneumococcal Polysaccharide Crm Conjugat...

    Merck & Co

    Dosage Form : Inj Susp

    Brand Name : Vaxneuvance

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    Approval Date :

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    Registration Country : Switzerland

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    Brand Name : Vaxneuvance

    U.S.A
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    Brand Name : Vaxneuvance

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    15-valent Pneumococcal Polysaccharide Crm Conjugat...

    Merck & Co

    Dosage Form : Inj Susp

    Brand Name : Vaxneuvance

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    Registration Country : Switzerland

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    03

    Brand Name : Campral

    U.S.A
    FCE Pharma
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    Brand Name : Campral

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Film-Coated Tablets

    Brand Name : Campral

    Dosage Strength : 300mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    Brand Name : Campral

    U.S.A
    FCE Pharma
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Filmtablet

    Brand Name : Campral

    Dosage Strength : 300mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    05

    Brand Name : DRIXORAL PLUS

    U.S.A
    FCE Pharma
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    Brand Name : DRIXORAL PLUS

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

    Merck & Co

    Dosage Form : TABLET, EXTENDED RELEASE...

    Brand Name : DRIXORAL PLUS

    Dosage Strength : 500MG;3MG;60MG

    Packaging :

    Approval Date : 1987-05-22

    Application Number : 19453

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Brand Name : Fosavance weekly tablets

    Dosage Strength : 70/5600

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Brand Name : Fosavance weekly tablets

    Dosage Strength : 70/2800

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Brand Name : Fosavance weekly tablets

    Dosage Strength : 70/5600

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Brand Name : Fosavance weekly tablets

    Dosage Strength : 70/2800

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    Brand Name : FOSAMAX

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : FOSAMAX

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    ALENDRONATE SODIUM

    Organon

    Dosage Form : TABLET;ORAL

    Brand Name : FOSAMAX

    Dosage Strength : EQ 5MG BASE **Federal ...

    Packaging :

    Approval Date : 1997-04-25

    Application Number : 20560

    Regulatory Info : DISCN

    Registration Country : USA

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    FDA Orange Book

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    Europe

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    01

    Brand Name : Vaxneuvance

    U.S.A
    FCE Pharma
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    Brand Name : Vaxneuvance

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    15-valent pneumococcal polysaccharide CRM conjugat...

    Merck & Co

    Dosage Form : Inj Susp

    Dosage Strength :

    Packaging :

    Brand Name : Vaxneuvance

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    02

    Brand Name : Vaxneuvance

    U.S.A
    FCE Pharma
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    Brand Name : Vaxneuvance

    U.S.A
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    FCE Pharma
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    Regulatory Info :

    Registration Country : Switzerland

    15-valent pneumococcal polysaccharide CRM conjugat...

    Merck & Co

    Dosage Form : Inj Susp

    Dosage Strength :

    Packaging :

    Brand Name : Vaxneuvance

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    03

    Brand Name : Campral

    U.S.A
    FCE Pharma
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    Brand Name : Campral

    U.S.A
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    FCE Pharma
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 300mg

    Packaging :

    Brand Name : Campral

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    Brand Name : Campral

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Campral

    U.S.A
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    FCE Pharma
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    Regulatory Info :

    Registration Country : Switzerland

    Acamprosatum

    Merck & Co

    Dosage Form : Filmtablet

    Dosage Strength : 300mg

    Packaging :

    Brand Name : Campral

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    05

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    FCE Pharma
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/2800

    Packaging :

    Brand Name : Fosavance weekly tablets

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    06

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/2800

    Packaging :

    Brand Name : Fosavance weekly tablets

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
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    Brand Name : Fosavance weekly tab...

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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/5600

    Packaging :

    Brand Name : Fosavance weekly tablets

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Brand Name : Fosavance weekly tab...

    U.S.A
    FCE Pharma
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    Brand Name : Fosavance weekly tab...

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum alendronicum; cholecalciferol (vitamin D3)

    Organon

    Dosage Form : Tabl

    Dosage Strength : 70/5600

    Packaging :

    Brand Name : Fosavance weekly tablets

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Brand Name : Famax

    U.S.A
    FCE Pharma
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    Brand Name : Famax

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Alendronate Sodium Trihydrate

    Merck & Co

    Dosage Form : Alendronic Acid 70Mg 4 Units' ...

    Dosage Strength : 4 CPR 70 mg

    Packaging :

    Brand Name : Famax

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    10

    Brand Name : Famax

    U.S.A
    FCE Pharma
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    Brand Name : Famax

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Alendronate Sodium Trihydrate

    Merck & Co

    Dosage Form : Alendronic Acid 10Mg 14 Joined...

    Dosage Strength : 14 CPR 10 mg

    Packaging :

    Brand Name : Famax

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Canada

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    01

    Brand Name : FOSAVANCE

    Canada
    FCE Pharma
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    Brand Name : FOSAVANCE

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE)

    ORGANON CANADA

    Dosage Form : TABLET

    Dosage Strength : 70MG

    Packaging :

    Brand Name : FOSAVANCE

    Approval Date :

    Application Number : 2276429

    Regulatory Info : Prescription

    Registration Country : Canada

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    02

    Brand Name : FOSAMAX

    Canada
    FCE Pharma
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    Brand Name : FOSAMAX

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    ALENDRONIC ACID (ALENDRONATE SODIUM)

    ORGANON CANADA

    Dosage Form : TABLET

    Dosage Strength : 70MG

    Packaging :

    Brand Name : FOSAMAX

    Approval Date :

    Application Number : 2245329

    Regulatory Info : Prescription

    Registration Country : Canada

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    03

    Brand Name : REGU-MATE SOLUTION 0...

    U.S.A
    FCE Pharma
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    Brand Name : REGU-MATE SOLUTION 0...

    U.S.A
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    Regulatory Info : Prescription

    Registration Country : Canada

    ALTRENOGEST

    Merck & Co

    Dosage Form : SOLUTION

    Dosage Strength : 2.2MG/ML

    Packaging : 150 ML/1 L

    Brand Name : REGU-MATE SOLUTION 0.22%

    Approval Date :

    Application Number : 641987

    Regulatory Info : Prescription

    Registration Country : Canada

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    04

    Brand Name : PARACILLIN SP

    U.S.A
    FCE Pharma
    Not Confirmed
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    Brand Name : PARACILLIN SP

    U.S.A
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    Regulatory Info : Prescription

    Registration Country : Canada

    AMOXICILLIN TRIHYDRATE

    Merck & Co

    Dosage Form : POWDER FOR SOLUTION

    Dosage Strength : 800MG/G

    Packaging : 250G/1000G

    Brand Name : PARACILLIN SP

    Approval Date :

    Application Number : 2281376

    Regulatory Info : Prescription

    Registration Country : Canada

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    05

    Brand Name : COTAZYM ECS 20

    Canada
    FCE Pharma
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    Brand Name : COTAZYM ECS 20

    Canada
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    FCE Pharma
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    Regulatory Info : Prescription

    Registration Country : Canada

    AMYLASE

    ORGANON CANADA

    Dosage Form : CAPSULE (DELAYED RELEASE)

    Dosage Strength : 100000UNIT

    Packaging : 100/250

    Brand Name : COTAZYM ECS 20

    Approval Date :

    Application Number : 821373

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    Brand Name : COTAZYM ECS 8

    Canada
    FCE Pharma
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    Brand Name : COTAZYM ECS 8

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    AMYLASE

    ORGANON CANADA

    Dosage Form : CAPSULE (DELAYED RELEASE)

    Dosage Strength : 42000UNIT

    Packaging : 100/500

    Brand Name : COTAZYM ECS 8

    Approval Date :

    Application Number : 502790

    Regulatory Info : Prescription

    Registration Country : Canada

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    Brand Name : COTAZYM

    Canada
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    Brand Name : COTAZYM

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    AMYLASE

    ORGANON CANADA

    Dosage Form : CAPSULE (IMMEDIATE RELEASE)

    Dosage Strength : 40000UNIT

    Packaging : 100/1000

    Brand Name : COTAZYM

    Approval Date :

    Application Number : 263818

    Regulatory Info : Prescription

    Registration Country : Canada

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    08

    Brand Name : SAPHRIS

    Canada
    FCE Pharma
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    Brand Name : SAPHRIS

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    ASENAPINE (ASENAPINE MALEATE)

    ORGANON CANADA

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging : 20/60

    Brand Name : SAPHRIS

    Approval Date :

    Application Number : 2374803

    Regulatory Info : Prescription

    Registration Country : Canada

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    Brand Name : SAPHRIS

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    Regulatory Info : Prescription

    Registration Country : Canada

    ASENAPINE (ASENAPINE MALEATE)

    ORGANON CANADA

    Dosage Form : TABLET

    Dosage Strength : 10MG

    Packaging : 20/60

    Brand Name : SAPHRIS

    Approval Date :

    Application Number : 2374811

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    Registration Country : Canada

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    Brand Name : DIPROSONE

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    Regulatory Info : Prescription

    Registration Country : Canada

    BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

    ORGANON CANADA

    Dosage Form : CREAM

    Dosage Strength : 0.05%/W/W

    Packaging :

    Brand Name : DIPROSONE

    Approval Date :

    Application Number : 323071

    Regulatory Info : Prescription

    Registration Country : Canada

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