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    Company profile for Emcure Pharmaceuticals

    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    About

    Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products. Its core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercializes across geographies. Emcure has launched 6 biosimilars in the Domestic Market & RoW markets &...
    Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products. Its core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercializes across geographies. Emcure has launched 6 biosimilars in the Domestic Market & RoW markets & Its subsidiary - Gennova is leading the creation of India’s first indigenous mRNA vaccine to combat COVID- 19 which is currently under trial.

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    CONTACT DETAILS

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    Emcure Pharmaceuticalsindia-flag Flag
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    M.I.D.C., Hinjawadi, Pune- 411 057
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey? Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands? At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaQuality, Reliability, TrustQuality, Reliability, Trust

    Quality, Reliability, Trust
    Quality, Reliability, Trust

    reelQuality, Reliability, Trust

    This PharmaReel highlights Rochem’s capabilities in sourcing and supplying Generic APIs and Excipients, driven by Quality, Reliability, and Trust through fully cGMP-compliant operations. With over 30 years of experience and 16 offices worldwide, Rochem continues to develop partnerships across the US, China, Europe, and South America.

    Impressions: 2824

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

    During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired  Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord).  Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation. 
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    Impressions: 7131

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-veranova-carbogen-lead-adc-investments-axplora-polfa-tarchomin-famar-expand-european-footprint

    #PharmaFlow by PHARMACOMPASS
    10 Jul 2025
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    NEWS #PharmaBuzz

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    KPRDO Notes Emcure’s Reply on Stockist Appointment
    KPRDO Notes Emcure’s Reply on Stockist Appointment

    17 Jul 2025

    // PHARMABIZ

    https://www.pharmabiz.com/NewsDetails.aspx?aid=179189&sid=1

    PHARMABIZ
    17 Jul 2025
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    Emcure, Sanofi ink Deal for Oral Anti-diabetic Products in India
    Emcure, Sanofi ink Deal for Oral Anti-diabetic Products in India

    17 Jul 2025

    // PRESS RELEASE

    https://www.emcure.com/wp-content/uploads/2025/07/Emcure-Sanofi-OAD-July-2025.pdf

    PRESS RELEASE
    17 Jul 2025
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    Emcure Rises as USFDA Issues Form 483 With Zero Observations
    Emcure Rises as USFDA Issues Form 483 With Zero Observations

    10 Jul 2025

    // BUSINESS STD

    https://www.business-standard.com/markets/news/emcure-pharma-rises-usfda-issues-form-483-with-zero-observations-pharma-stock-pharma-sector-bse-sensex-indian-stock-markets-125071000370_1.html

    BUSINESS STD
    10 Jul 2025
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    Emcure to acquire remaining stake in Zuventus Healthcare
    Emcure to acquire remaining stake in Zuventus Healthcare

    23 Jun 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/emcure-to-acquire-remaining-stake-in-zuventus-healthcare-17299

    INDPHARMAPOST
    23 Jun 2025
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    KPRDO Questions Emcure’s Stockist Pick for Special Sales
    KPRDO Questions Emcure’s Stockist Pick for Special Sales

    16 Jun 2025

    // PHARMABIZ

    https://www.pharmabiz.com/NewsDetails.aspx?aid=178489&sid=1

    PHARMABIZ
    16 Jun 2025
    Share Share
    Emcutix, Canada-based Mantra Pharma launch Ureaderm
    Emcutix, Canada-based Mantra Pharma launch Ureaderm

    14 May 2025

    // EXPRESS PHARMA

    https://www.expresspharma.in/emcutix-canada-based-mantra-pharma-launch-ureaderm/

    EXPRESS PHARMA
    14 May 2025
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    ALL APIs

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

    01

    Pentamidine Isethionate

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

    AGGSpend
    Not Confirmed
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    Pentamidine Isethionate

    India

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

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    AGGSpend
    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 : Reviewed

    Rev. Date : 2019-07-21

    Pay. Date : 2019-06-12

    DMF Number : 33938

    Submission : 2019-06-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-169 - Rev 01

    Issue Date : 2025-02-12

    Type : Chemical

    Substance Number : 1137

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-12-30

    Valid Till : 2025-12-30

    Written Confirmation Number : WC-0547

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-930

    Start Marketing Date : 2022-02-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (15kg/15kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    02

    Acetazolamide

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

    AGGSpend
    Not Confirmed
    arrow

    Acetazolamide

    India

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

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    AGGSpend
    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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-06

    DMF Number : 20299

    Submission : 2007-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-203 - Rev 02

    Issue Date : 2025-02-26

    Type : Chemical

    Substance Number : 454

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-801

    Start Marketing Date : 2008-06-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (15kg/15kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
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    #PipelineProspector

    Market
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    03

    Bendamustine Hydrochloride

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

    AGGSpend
    Not Confirmed
    arrow

    Bendamustine Hydrochloride

    India

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

    arrow
    AGGSpend
    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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-19

    Pay. Date : 2013-09-18

    DMF Number : 25807

    Submission : 2012-03-31

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 302MF10138

    Registrant's Address : Emcure House, T-184, M. I. D. C. ,Bhosari,Pune,Maharashtra,India

    Initial Date of Registration : 2020-11-26

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-834

    Start Marketing Date : 2023-09-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    04

    Carmustine

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

    AGGSpend
    Not Confirmed
    arrow

    Carmustine

    India

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

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    AGGSpend
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-11-10

    Pay. Date : 2016-10-17

    DMF Number : 22905

    Submission : 2009-06-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-192 - Rev 02

    Issue Date : 2023-04-26

    Type : Chemical

    Substance Number : 1187

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-823

    Start Marketing Date : 2013-04-04

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (130g/130g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Fingolimod Hydrochloride

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

    AGGSpend
    Not Confirmed
    arrow

    Fingolimod Hydrochloride

    India

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

    arrow
    AGGSpend
    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
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-07

    Pay. Date : 2014-06-23

    DMF Number : 28235

    Submission : 2014-06-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-413 - Rev 00

    Issue Date : 2024-04-22

    Type : Chemical

    Substance Number : 2988

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-902

    Start Marketing Date : 2023-12-22

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
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    06

    Flecainide

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

    AGGSpend
    Not Confirmed
    arrow

    Flecainide

    India

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

    arrow
    AGGSpend
    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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-04

    Pay. Date : 2014-02-05

    DMF Number : 27859

    Submission : 2014-01-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-155 - Rev 05

    Issue Date : 2025-03-06

    Type : Chemical

    Substance Number : 1324

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-897

    Start Marketing Date : 2021-07-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (5kg/5kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Leflunomide

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

    AGGSpend
    Not Confirmed
    arrow

    Leflunomide

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-07-24

    Pay. Date : 2025-07-18

    DMF Number : 16124

    Submission : 2002-09-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-269 - Rev 02

    Issue Date : 2024-09-11

    Type : Chemical

    Substance Number : 2330

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-911

    Start Marketing Date : 2015-10-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Mycophenolate Mofetil

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

    AGGSpend
    Not Confirmed
    arrow

    Mycophenolate Mofetil

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25744

    Submission : 2012-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-089 - Rev 02

    Issue Date : 2023-04-21

    Type : Chemical

    Substance Number : 1700

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-876

    Start Marketing Date : 2023-09-14

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (6kg/6kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2023-04-14

    Registration Number : 20230414-209-J-1477

    Manufacturer Name : Emcure Pharmaceuticals Limited

    Manufacturer Address : Plot No. D-24 & D-24/1, Kurkumbh MIDC, Tal. Daund, Pune-413802, Maharashtra State India

     VMF Others AUDIT
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    Market
    Place

    09

    Propofol

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

    AGGSpend
    Not Confirmed
    arrow

    Propofol

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-10

    Pay. Date : 2014-01-22

    DMF Number : 27390

    Submission : 2013-08-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-066 - Rev 00

    Issue Date : 2024-07-12

    Type : Chemical

    Substance Number : 1558

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Market
    Place

    10

    Rizatriptan Benzoate

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

    AGGSpend
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    India

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

    arrow
    AGGSpend
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-04

    DMF Number : 25764

    Submission : 2012-03-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-095 - Rev 01

    Issue Date : 2024-01-29

    Type : Chemical

    Substance Number : 2585

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14593-872

    Start Marketing Date : 2021-07-22

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (15kg/15kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

    read-more
    read-more

    01

    4'-acetyloxy 2, 4-difluorobiphenyl

    India
    AGGSpend
    Not Confirmed
    arrow

    02

    Acamprosate Calcium Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    03

    Acetazolamide Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    04

    Adenosine Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    05

    Aminocaproic Acid Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    06

    Amiodarone Hydrochloride Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    07

    Anastrozole Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    08

    Argatroban Usp

    India
    AGGSpend
    Not Confirmed
    arrow

    09

    Arsenic Trioxide

    India
    AGGSpend
    Not Confirmed
    arrow

    10

    Atazanavir Sulfate Usp

    India
    AGGSpend
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    FDA Orange Book

    read-more
    read-more

    01

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow
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    RLD :

    TE Code :

    ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE

    Emcure Pharmaceuticals

    Dosage Form : TABLET

    Proprietary Name : ABACAVIR || DOLUTEGRAVIR...

    Dosage Strength : 50MG

    Approval Date :

    Application Number : 212181

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    02

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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    RLD :

    TE Code :

    ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE

    Emcure Pharmaceuticals

    Dosage Form : TABLET

    Proprietary Name : ABACAVIR || DOLUTEGRAVIR...

    Dosage Strength : 300MG

    Approval Date :

    Application Number : 212181

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    03

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ABACAVIR || DOLUTEGR...

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE

    Emcure Pharmaceuticals

    Dosage Form : TABLET

    Proprietary Name : ABACAVIR || DOLUTEGRAVIR...

    Dosage Strength : 600MG

    Approval Date :

    Application Number : 212181

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

    Product
    Web Link

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    Market
    Place

    04

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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    RLD :

    TE Code :

    ATAZANAVIR SULFATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ATAZANAVIR SULFATE

    Dosage Strength : 100MG

    Approval Date :

    Application Number : 78785

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    05

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
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    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    ATAZANAVIR SULFATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ATAZANAVIR SULFATE

    Dosage Strength : 150MG

    Approval Date :

    Application Number : 78785

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    06

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    ATAZANAVIR SULFATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ATAZANAVIR SULFATE

    Dosage Strength : 200MG

    Approval Date :

    Application Number : 78785

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    07

    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
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    Brand Name : ATAZANAVIR SULFATE

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    ATAZANAVIR SULFATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ATAZANAVIR SULFATE

    Dosage Strength : 300MG

    Approval Date :

    Application Number : 200196

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    08

    Brand Name : ATAZANAVIR SULFATE; ...

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : ATAZANAVIR SULFATE; ...

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    ATAZANAVIR SULFATE; RITONAVIR

    Emcure Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : ATAZANAVIR SULFATE; RITO...

    Dosage Strength : 300MG; 100MG

    Approval Date :

    Application Number : 205508

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    09

    Brand Name : BENZONATATE

    India
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : BENZONATATE

    India
    AGGSpend
    Not Confirmed
    arrow
    • fda
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    RLD : No

    TE Code : AA

    BENZONATATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BENZONATATE

    Dosage Strength : 100MG

    Approval Date : 2007-07-30

    Application Number : 40682

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    blank

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    Market
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    10

    Brand Name : BENZONATATE

    India
    AGGSpend
    Not Confirmed
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    Brand Name : BENZONATATE

    India
    AGGSpend
    Not Confirmed
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    RLD : No

    TE Code : AA

    BENZONATATE

    Emcure Pharmaceuticals

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BENZONATATE

    Dosage Strength : 200MG

    Approval Date : 2007-07-30

    Application Number : 40682

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

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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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    Europe

    read-more
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    01

    Brand Name : ENTOCIR

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : ENTOCIR

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Budesonide

    Tillomed Laboratories Ltd

    Dosage Form : Modified Release Hard Capsules

    Dosage Strength : 3 mg

    Packaging : 50 UNITS 3 MG - OR...

    Brand Name : ENTOCIR

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    02

    Brand Name : CINACALCET TILLOMED

    United Kingdom
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : CINACALCET TILLOMED

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Tillomed Laboratories Ltd

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 30 mg

    Packaging : 28 UNITS 30 MG - O...

    Brand Name : CINACALCET TILLOMED

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
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    03

    Brand Name : CINACALCET TILLOMED

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : CINACALCET TILLOMED

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Tillomed Laboratories Ltd

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 60 mg

    Packaging : 28 UNITS 60 MG - O...

    Brand Name : CINACALCET TILLOMED

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    04

    Brand Name : CINACALCET TILLOMED

    United Kingdom
    AGGSpend
    Not Confirmed
    arrow

    Brand Name : CINACALCET TILLOMED

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Italy

    Cinacalcet

    Tillomed Laboratories Ltd

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 90 mg

    Packaging : 28 UNITS 90 MG - O...

    Brand Name : CINACALCET TILLOMED

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    05

    Brand Name : GABANEX

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : GABANEX

    United Kingdom
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    AGGSpend
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Gabapentin

    Tillomed Laboratories Ltd

    Dosage Form : Capsule Rigide

    Dosage Strength : 100 mg

    Packaging : 50 UNITS 100 MG - ...

    Brand Name : GABANEX

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    06

    Brand Name : MYCOPHENOLATE MOFETI...

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : MYCOPHENOLATE MOFETI...

    United Kingdom
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    AGGSpend
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Mycophenolate mofetil

    Tillomed Laboratories Ltd

    Dosage Form : Hard Capsules

    Dosage Strength : 250 mg

    Packaging : 100 UNITS 250 MG -...

    Brand Name : MYCOPHENOLATE MOFETILE TILLOM...

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    07

    Brand Name : MYCOPHENOLATE MOFETI...

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : MYCOPHENOLATE MOFETI...

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Italy

    Mycophenolate mofetil

    Tillomed Laboratories Ltd

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 500 mg

    Packaging : 50 UNITS 500 MG - ...

    Brand Name : MYCOPHENOLATE MOFETILE TILLOM...

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    08

    Brand Name : POSACONAZOLE TILLOME...

    United Kingdom
    AGGSpend
    Not Confirmed
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    Brand Name : POSACONAZOLE TILLOME...

    United Kingdom
    arrow
    AGGSpend
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info :

    Registration Country : Italy

    Posaconazole

    Tillomed Laboratories Ltd

    Dosage Form : Oral Suspension

    Dosage Strength : 40 mg/ml

    Packaging : 105 ML 40 MG/ML - ...

    Brand Name : POSACONAZOLE TILLOMED

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Busulfan

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

    AGGSpend
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    Busulfan

    India

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25836

    Submission : 2012-04-01

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    FDA

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    01

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-08

    Emcure Pharmaceuticals

    City : Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-08

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    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-04-04

    Emcure Pharmaceuticals

    City : Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-04-04

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    FDA Audited

    USA
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    Not Confirmed
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    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-02-07

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-02-07

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    FDA Audited

    USA
    AGGSpend
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    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-04-26

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-04-26

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    05

    FDA Audited

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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-18

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-18

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    06

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-06-09

    Emcure Pharmaceuticals

    City : Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-06-09

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    07

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-11-22

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-11-22

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    08

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-11-10

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-11-10

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    09

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
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    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-08-19

    Emcure Pharmaceuticals

    City : Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-08-19

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    10

    FDA Audited

    USA
    AGGSpend
    Not Confirmed
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    FDA Audited

    USA
    arrow
    AGGSpend
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-02-19

    Emcure Pharmaceuticals

    City : Hinjwadi, Pune

    State :

    Country/Area : India

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-02-19

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    EDQM

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    01

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
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    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : UK MIA 4211...

    EudraGMDP Key : 36141

    Country : United Kingdom

    Issue Date : 2016-04-20

    Post Code : LU2 8DL

    NCA Ref : 12716989-EMC...

    City : LUTON

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    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
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    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : UK MIA 4211...

    EudraGMDP Key : 26394

    Country : United Kingdom

    Issue Date : 2014-05-28

    Post Code : HA7 1JS

    NCA Ref : 9152145-EMCU...

    City : STANMORE

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    03

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : IT/E/GMP/16...

    EudraGMDP Key : 30726

    Country : U.S.A

    Issue Date : 2013-11-14

    Post Code : 08816

    NCA Ref : 307261421315...

    City : East Brunswick

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    04

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : UK GMP 2155...

    EudraGMDP Key : 11837

    Country : India

    Issue Date :

    Post Code : IN 411 057

    NCA Ref : 21992- EMCUR...

    City : PUNE

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    05

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : UK GMP 2155...

    EudraGMDP Key : 11837

    Country : India

    Issue Date :

    Post Code : IN 411 057

    NCA Ref : 21992- EMCUR...

    City : PUNE

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    06

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
    arrow

    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : UK GMP 2155...

    EudraGMDP Key : 10405

    Country : India

    Issue Date :

    Post Code : IND-411 057

    NCA Ref : 2387410-EMCU...

    City : PUNE

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    07

    GMP Certified

    EU
    AGGSpend
    Not Confirmed
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    GMP Certified

    EU
    arrow
    AGGSpend
    Not Confirmed

    Emcure Pharmaceuticals

    Type : GMP Certificates

    Number : 420-0006/01...

    EudraGMDP Key : 9145

    Country : India

    Issue Date :

    Post Code : 411 057

    NCA Ref : 9.1451278507...

    City : PUNE

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    ABOUT THIS PAGE

    Contact Emcure Pharmaceuticals and get a quotation

    Emcure Pharmaceuticals is a supplier offers 139 products (APIs, Excipients or Intermediates).

    Find a price of Pentamidine Isethionate bulk with DMF, CEP, WC offered by Emcure Pharmaceuticals

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    Find a price of (S)- METHYL-3- (4-BIS(2-HYDROXYETHYL) AMINO) PHENYL) -2 - (TERT- BUTOXYCARBONYLAMINO) PROPANOATE bulk with DMF offered by Emcure Pharmaceuticals

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