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    Company profile for Calyx Chemicals & Pharmaceuticals

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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    Inke S.A: APIs manufacturing plant.

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    Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    EVENTS

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    About

    CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been successfully inspected and approved by major regulatory authorities, including the USFDA, EDQM, WHO-Geneva, and other international agencies. The company has been a pioneer and industry leader in the manufacturing of APIs, particularly in the therapeut...
    CALYX is a manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, with its manufacturing facility located in Tarapur, Maharashtra (India). The site has been successfully inspected and approved by major regulatory authorities, including the USFDA, EDQM, WHO-Geneva, and other international agencies. The company has been a pioneer and industry leader in the manufacturing of APIs, particularly in the therapeutic areas of Anti-Tuberculosis, Anti-Malarial, and Macrolide segments, catering to the treatment of acute diseases.

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    India
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    Unit no.110, Marwah's Complex,Krishnalal Marwah Marg,Off. Saki Vihar Road, And...
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    enquiries@pharmacompass.com
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    mic“We are building capabilities to stay ahead of the curve, and align with future needs of global healthcare”

    This week, SpeakPharma interviews Girish Chovatia, Chairman and Managing Director of Ami Lifesciences. Since its inception in 2006, Ami Lifesciences has emerged as one of the fastest-growing API manufacturers from India, delivering high-quality active pharmaceutical ingredients (APIs) to global partners across more than 60 countries. With a portfolio of 80+ APIs and strong regulatory accreditations, including those from the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines & HealthCare (EDQM), and the Pharmaceuticals and Medical Devices Agency (PMDA), the company has built a reputation for innovation, reliability, and customer-centricity.Ami Lifesciences’ ability to combine chemistry expertise with forward-looking strategies such as backward integration, custom synthesis, and a growing focus on platform technologies for next-generation therapeutics sets it apart. The company’s state-of-the-art infrastructure, emphasis on regulatory compliance, and quality culture built from the development stage enable it to serve as a trusted partner to leading pharmaceutical companies worldwide.In this interview, Chovatia shares key milestones in Ami Lifesciences’ growth journey, its approach to sustainability and innovation, and vision for expanding into new therapeutic areas and technologies to strengthen their global presence.Ami Lifesciences has grown rapidly since it began API operations in 2006. What have been the key strategic decisions or turning points that have fueled this growth?When we started API operations in 2006, we knew we were entering a highly competitive, globalized market. The key turning points in our journey were rooted in making bold but carefully thought-out strategic decisions. The first was building a quality-first culture from day one. We invested early in strong regulatory systems, which allowed us to secure approvals from agencies like FDA, EDQM and, PMDA, opening global markets.Another major factor was our focus on complex chemistry and high-barrier molecules. Instead of competing only in crowded, generic APIs, we decided to differentiate ourselves by developing technically challenging products where our chemistry expertise could shine.We also expanded our global footprint quickly, entering over 60 countries with a diverse product portfolio. Partnerships with leading pharmaceutical companies gave us both credibility and growth momentum. Each milestone—from our first CEP approval to our first FDA clearance—strengthened our foundation.Most importantly, we built a team that believes in long-term value creation, not shortcuts. That culture of quality, innovation, and customer trust continues to fuel our growth.HIGHLIGHTS// Building quality-first culture/focus on complex chemistry/expanding global footprint/belief in long-term value creationWith 80 APIs and a presence in more than 60 countries, how does Ami Lifesciences ensure regulatory compliance and maintain quality standards across such a diverse global footprint?For us, regulatory compliance is not just a requirement—it is the backbone of our credibility. We’ve built a quality culture that starts from the development stage itself. Our dedicated DQA (Development Quality Assurance) and DRA (Development Regulatory Affairs) teams are involved right from early R&D, ensuring that every molecule is designed with regulatory expectations in mind.All our facilities operate under stringent cGMP (current good manufacturing practices) conditions and are routinely audited by leading authorities, including the FDA, EDQM, PMDA, and multiple global partners. We have built robust systems for documentation, training, and monitoring that keep compliance non-negotiable.Equally important is the mindset—we train our teams to think “compliance-first” in every activity, big or small. Whether it’s a lab scientist, a production engineer, or a QA associate, everyone knows that quality and compliance are paramount.This integration of systems, people and, culture ensures that no matter which market we serve—be it the US, Europe, Japan, or emerging economies—our partners receive products of consistently high standards.HIGHLIGHTS// Compliance backbone of credibility/stringent cGMP conditions/‘compliance-first mindset’/consistency in high standardsHow does Ami Lifesciences’ backward integration across key molecules strengthen cost competitiveness and supply chain assurance for its global clients?Backward integration has been a conscious strategy for us. In today’s environment, customers not only seek high-quality APIs but also security of supply and cost competitiveness. By investing in in-house development and manufacture of key intermediates, we reduce dependency on external vendors and volatile supply chains.This gives us multiple advantages. First, it brings down costs and improves pricing stability, making us a more competitive partner globally. Second, it gives us greater control over timelines—something our clients value tremendously, especially in regulated markets. And third, it ensures resilience; even during global disruptions. We can assure our partners of uninterrupted supply.In a market where reliability is as critical as cost, our backward integration strategy has become a cornerstone of trust and long-term partnerships.HIGHLIGHTS// Backward integration strategy/focus on in-house development/lower costs/control over timelines global footprint/resilience during disruptionsHow is Ami Lifesciences leveraging R&D capabilities and custom synthesis to drive innovation in various therapeutic areas? Our R&D strength has always been at the core of our differentiation. We have over 150 scientists dedicated to developing APIs across complex therapeutic areas such as cardiovascular, anti-diabetic, and central nervous system (CNS) disorders.What sets us apart is our ability to go beyond standard generics. We focus on process innovation—green chemistry, enzymatic applications, and continuous improvement—to make synthesis routes not only cost-effective but also environmentally responsible.Custom synthesis is another pillar. Many of our global partners approach us for tailor-made solutions—whether it’s a new intermediate, a complex chiral molecule, or a high-barrier API. Our flexible R&D infrastructure allows us to design and scale processes efficiently, from grams in the lab to multi-ton manufacturing.By marrying strong chemistry capabilities with customer collaboration, we’ve positioned ourselves as more than a manufacturer—we’re an innovation partner contributing to faster, safer, and more affordable therapies worldwide.HIGHLIGHTS// Strong R&D capabilities/complex therapeutic expertise/green chemistry/custom synthesis solutions/innovation partner for safer therapiesWhat are the next big milestones Ami Lifesciences is targeting in terms of product development and global expansion?Looking ahead, we see the future of Ami Lifesciences in both depth and diversification. On the product side, we are expanding into next-generation therapeutics—with focus areas including oncology APIs, ADC payloads and linkers, short peptides, and select biotechnology platforms. These are high-value, high-science areas where our chemistry expertise and process innovation can create significant impact.We are also investing in platform technologies that can be applied across multiple therapeutic areas, giving us a strategic edge in next-gen molecules.From a global perspective, our milestones include broadening our presence in regulated markets like the US, Europe, and Japan, while simultaneously strengthening our reach in fast-growing markets across Asia, LATAM, and Africa.Our guiding principle is to stay ahead of the curve—building a portfolio and capabilities that align with where global healthcare is heading, not just where it is today.HIGHLIGHTS// Expanding to new-gen therapeutics/investing in platform technologies/broadening presence in regulated markets/staying ahead of the curveCould you elaborate on Ami Lifesciences’ ESG initiatives and how they are integrated into your manufacturing and business strategy?Sustainability is no longer optional—it’s integral to how we do business. At Ami, we’ve made ESG a central pillar of our growth strategy.On the environmental front, we are pioneers in integrating green chemistry and enzymatic applications into our processes. By leveraging biocatalysis, we reduce reliance on harsh chemicals, improve atom economy, and minimize energy usage. Our plants are designed for solvent recovery, water recycling, and energy efficiency, with strong commitments to waste reduction and zero liquid discharge.Socially, we invest heavily in our people and communities. From training and development to ensuring a safe workplace, we believe our people are our greatest asset. Beyond our facilities, we engage in education, healthcare, and environmental initiatives that uplift surrounding communities.On governance, we run with transparency, accountability, and ethics at the forefront. Our systems ensure compliance not just with laws but with global best practices in corporate responsibility.This holistic ESG framework ensures that as we grow, we do so responsibly create value for customers, employees, communities, and the environment alike.HIGHLIGHTS// ESG central to growth strategy/energy and resource efficiency/waste reduction and zero liquid discharge/holistic responsible growthHow does Ami Lifesciences’ manufacturing infrastructure enhance scalability and quality for its clients?Our manufacturing infrastructure is built for both flexibility and scale. Our Karakhadi facility (in Gujarat) is approved by leading agencies such as FDA, EDQM, ANVISA (Brazilian Health Regulatory Agency), NMPA (National Medical Products Administration of China) and KMFDS (Korean Ministry of Food and Drug Safety). Our products are filed in many other regulatory agencies like PMDA of Japan, NMPA of China, Therapeutic Goods Administration of Australia and Health Canada; giving our partners complete confidence in compliance and quality.The facility has multi-purpose production blocks, allowing us to handle diverse chemistries and scale projects seamlessly—from grams in the lab to multi-ton commercial quantities. This scalability is a key advantage for customers looking for a partner that can support them across the product lifecycle.We further strengthen supply reliability through backward integration of intermediates, which secures both cost efficiency and supply assurance.What makes us unique is the way we integrate quality and sustainability into manufacturing. By embedding quality from the development stage and incorporating green chemistry and enzymatic processes, we ensure that our output is not only reliable and compliant but also environmentally responsible.This combination of regulatory strength, scalability, and sustainable practices makes Ami a trusted long-term partner for leading pharma companies worldwide.HIGHLIGHTS// Flexible, scalable manufacturing infrastructure/facility approved by leading regulators/multi-purpose production blocks/quality, sustainability integrated into manufacturing 

    Impressions: 85

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    https://www.pharmacompass.com/speak-pharma/we-are-building-capabilities-to-stay-ahead-of-the-curve-and-align-with-future-needs-of-global-healthcare

    PharmaCompass
    13 Oct 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaPartner in End-to-End API ManufacturingPartner in End-to-End API Manufacturing

    Partner in End-to-End API Manufacturing
    Partner in End-to-End API Manufacturing

    reelPartner in End-to-End API Manufacturing

    This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

    Impressions: 2174

    read-more

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards.  Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards.  Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.
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    Impressions: 6926

    https://www.pharmacompass.com/radio-compass-blog/global-api-micronization-market-set-to-surge-49-by-2030-led-by-specialized-industry-pioneers

    #Phispers by PHARMACOMPASS
    10 Sep 2025
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    NEWS #PharmaBuzz

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    Calyx and Invicro Rebrand as Perceptive
    Calyx and Invicro Rebrand as Perceptive

    01 Oct 2024

    // CONTRACT PHARMA

    https://www.contractpharma.com//contents/view_breaking-news/2024-10-01/calyx-and-invicro-rebrand-as-perceptive/?widget=listSection

    CONTRACT PHARMA
    01 Oct 2024
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    Calyx Selected as Approved Partner by ProTrials Research
    Calyx Selected as Approved Partner by ProTrials Research

    21 Mar 2022

    // CONTRACTPHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2022-03-21/calyx-selected-as-approved-partner-by-protrials-research/

    CONTRACTPHARMA
    21 Mar 2022
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    Calyx EDC Selected for RWE Data Collection in Lengthy, Late Phase Trial
    Calyx EDC Selected for RWE Data Collection in Lengthy, Late Phase Trial

    21 Feb 2022

    // PRNEWSWIRE

    https://www.prnewswire.com/news-releases/calyx-edc-selected-for-rwe-data-collection-in-lengthy-late-phase-trial-301485000.html

    PRNEWSWIRE
    21 Feb 2022
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    Calyx Extends Partnership with Leading CRO
    Calyx Extends Partnership with Leading CRO

    14 Dec 2021

    // CONTRACTPHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2021-12-14/calyx-extends-partnership-with-leading-cro/?widget=listSection

    CONTRACTPHARMA
    14 Dec 2021
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    Calyx Expands US Presence in Response to Growing Demand
    Calyx Expands US Presence in Response to Growing Demand

    22 Jul 2021

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2021-07-22/calyx-expands-us-presence-in-response-to-growing-demand/?widget=listSection

    CONTRACT PHARMA
    22 Jul 2021
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    Calyx Expands US Presence in Response to Growing Demand
    Calyx Expands US Presence in Response to Growing Demand

    19 Jul 2021

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/calyx-expands-us-presence-in-response-to-growing-demand-301335698.html

    PR NEWSWIRE
    19 Jul 2021
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Erythromycin

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

    Aus. Peptide Conference
    Not Confirmed
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    Erythromycin

    India

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

    arrow
    Aus. Peptide Conference
    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 : 2016-11-10

    Pay. Date : 2016-09-27

    DMF Number : 20137

    Submission : 2006-12-14

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2012-284 - Rev 00

    Issue Date : 2020-04-02

    Type : Chemical

    Substance Number : 179

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-514

    Start Marketing Date : 2008-02-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Isoniazid

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Isoniazid

    India

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

    arrow
    Aus. Peptide Conference
    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 : 2015-10-14

    Pay. Date : 2015-09-30

    DMF Number : 21322

    Submission : 2008-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-108 - Rev 04

    Issue Date : 2024-08-02

    Type : Chemical

    Substance Number : 146

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-914

    Start Marketing Date : 2009-09-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Pyrazinamide

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Pyrazinamide

    India

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

    arrow
    Aus. Peptide Conference
    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 : 2015-10-30

    Pay. Date : 2015-10-15

    DMF Number : 15553

    Submission : 2001-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-036 - Rev 06

    Issue Date : 2025-05-14

    Type : Chemical

    Substance Number : 859

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-165

    Start Marketing Date : 2009-09-10

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2009-09-24

    Registration Number : 20090924-110-F-42-03

    Manufacturer Name : Calyx Chemicals & Pharmaceuticals Ltd

    Manufacturer Address : N 102, 90, 91 MIDC, TARAPUR,BOISAR PALGHAR 401506 MAHARASHTRA STATE, INDIA

     VMF Others AUDIT
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    04

    Zopiclone

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Zopiclone

    India

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

    arrow
    Aus. Peptide Conference
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15518

    Submission : 2001-06-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2001-203 - Rev 06

    Issue Date : 2024-05-30

    Type : Chemical

    Substance Number : 1060

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-265

    Start Marketing Date : 2009-09-10

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Fluocytosine

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Fluocytosine

    India

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

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    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23503

    Submission : 2010-01-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-019 - Rev 00

    Issue Date : 2023-07-05

    Type : Chemical

    Substance Number : 766

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66639-008

    Start Marketing Date : 2009-06-30

    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

    06

    Artemether

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Artemether

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23968

    Submission : 2010-07-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-118

    Start Marketing Date : 2015-01-12

    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

    07

    Lumefantrine

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Lumefantrine

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23966

    Submission : 2010-07-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-24

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0088

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66639-125

    Start Marketing Date : 2015-01-13

    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

    Cetirizine Dihydrochloride

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Cetirizine Dihydrochloride

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21396

    Submission : 2008-03-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66639-355

    Start Marketing Date : 2009-09-24

    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

    09

    Erythromycin Estolate

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Erythromycin Estolate

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20383

    Submission : 2007-03-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66639-555

    Start Marketing Date : 2015-01-09

    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

    10

    Erythromycin Stearate

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Erythromycin Stearate

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-28

    Pay. Date : 2016-10-14

    DMF Number : 22061

    Submission : 2008-10-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66639-003

    Start Marketing Date : 2009-09-02

    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

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    Contact Calyx Chemicals & Pharmaceuticals and get a quotation

    Calyx Chemicals & Pharmaceuticals is a supplier offers 46 products (APIs, Excipients or Intermediates).

    Find a price of Erythromycin bulk with DMF, CEP offered by Calyx Chemicals & Pharmaceuticals

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    Find a price of CAS 134931-01-4 bulk offered by Calyx Chemicals & Pharmaceuticals

    Find a price of CAS 76801-85-9 bulk offered by Calyx Chemicals & Pharmaceuticals

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