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    Company profile for Alembic Pharmaceuticals Limited

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    EVENTS

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    About

    Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.

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    CONTACT DETAILS

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    Alembic Pharmaceuticals Limitedindia-flag Flag
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    India
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    Alembic Road, Vadodara - 390 003, Gujarat
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    http://www.alembic-india.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “We bridge the gap between chemistry and performance to deliver precise, optimized micronization for complex APIs.”

    mic“We bridge the gap between chemistry and performance to deliver precise, optimized micronization for complex APIs.”

    This week, SpeakPharma interviews Stefano Martinoli, Chief Executive Officer of Munit SA, a Swiss company that specializes in micronization of active pharmaceutical ingredients (APIs) and other pharmaceutical compounds. Stefano Martinoli discusses Munit’s 60-year legacy, how micronization of APIs has improved therapeutic effects of drugs, and how the group is today a partner in drug development for its more than 150 global customers. He says innovation is a mindset at Munit, which is rooted in adaptability, foresight, and a deep culture of problem-solving. Could you share Munit SA’s journey over the past 60 years and explain how you’ve built such a strong global presence with over 150 customers? Munit’s story is one of innovation and vision. Our entrepreneurial journey began in 1918, rooted in powder handling and particle size engineering. The real breakthrough came in the 1960s, when my father pioneered the Spiral Jet Mill technology. In 1962, at the age of 24, he designed the first Spiral Jet Mill, placing us at the forefront of a field that would later revolutionize pharmaceuticals. Initially, this technology served the fine chemical industry, but in the early 1970s my father foresaw its immense potential for healthcare. He realized that micronization, or the mechanical reduction of particle size of APIs, could directly improve patients’ lives by enhancing APIs’ solubility. Better solubility means faster therapeutic effects and fewer side effects, which are critical advances for patient well-being. Founded in 1978, Microchem pioneered contract micronization in Italy before expanding into Switzerland to better serve global markets. In the late 1990s, we were the first in our field to introduce glove-box isolators for highly potent APIs, setting new safety standards. Today, under the Munit umbrella, Jetpharma (Switzerland) and Microchem (Italy) operate together, offering clients dual-site reliability that reduces supply chain risks and ensures business continuity. Over the decades, this vision has guided us to become more than just a service provider: we are partners in drug development. What sets us apart is our dual expertise, both in the technology itself and in the science of micronization. We don’t just operate equipment; we adapt it to the unique properties of each API, customizing processes and technological solutions to achieve the highest-quality outcomes. Today, with more than 150 global customers and six decades of proven excellence, Munit is recognized as a pioneer and a leader in pharmaceutical micronization. Our best-in-class processes, unmatched flexibility, and unrivaled expertise make us the go-to partner for companies that demand innovation, reliability, and speed in bringing their therapies to market. HIGHLIGHTS// Story of innovation/micronization and better solubility/faster therapeutic effects/fewer side effects/advancement in patient wellbeing/partners in drug development How does Munit foster innovation in micronization and particle engineering to stay ahead of evolving pharmaceutical needs? For Munit, innovation goes far beyond simply maintaining technological leadership — it’s about anticipating what’s next and shaping solutions that meet tomorrow’s pharmaceutical needs. Innovation, to us, is not just about machines or methods; it’s a mindset rooted in adaptability, foresight, and a deep culture of problem-solving. The pharmaceutical environment is constantly evolving: increasing molecular complexity, stricter regulations, and ever-higher patient expectations. To stay ahead, we focus on three pillars, responsiveness, vision, and precision. We respond rapidly to new challenges, forecast future trends to prepare our partners for what’s coming, and align seamlessly with regulatory shifts. At the heart of our work is one simple mission: solving complex solubility challenges to enhance the bioavailability of APIs and ultimately improve patient outcomes. Positioned between API synthesis and final drug formulation, our role in the value chain is critical, ensuring that promising molecules become effective, reliable medicines. What makes Munit different is that we don’t just provide technology; we deliver confidence. With decades of proven expertise, we give pharmaceutical companies what they need most: a reliable, long-term partner who can guarantee performance, consistency, and speed in the most demanding projects. HIGHLIGHTS// Shaping solutions that meet tomorrow’s needs/innovation mindset/focus on responsiveness, vision, precision/reliable long-term partners How does Munit ensure high-performance service delivery to its pharmaceutical clients? At Munit, delivering high-performance service means going beyond technical proficiency — we ensure our clients achieve faster, safer, and more reliable results. Every project has its own challenges, and our strength lies in anticipating them and adapting with agility. This ability to align with client needs (whether in early-stage R&D or commercial-scale production) is what makes us a long-term partner in the pharmaceutical value chain. Our teams bring decades of experience and specialized expertise that translate into concrete benefits for our clients: faster project turnaround, consistent compliance with global regulatory standards, and reduced risks across the supply chain. By combining deep process knowledge with flexibility, we help pharmaceutical companies accelerate time-to-market while safeguarding quality and repeatability. As a family-owned business, our culture of trust and long-term commitment drives everything we do. This foundation allows us to guarantee continuity, responsiveness, and the reliability that global pharma companies require in their strategic partners. Simply put: with Munit, clients know their projects are in expert hands, from grams to tons, from R&D to commercialization. HIGHLIGHTS// Going beyond technical proficiency/experience, expertise translate into benefits for clients/accelerate time to market How does Munit leverage its advanced milling technologies to support customers in achieving optimal particle size and consistency, especially for complex APIs? Munit holds a unique position in the market because we know how to adapt, refine, and customize processes to the exact needs of each API. Decades of experience across hundreds of molecules have allowed us to fine-tune our technology and ensure optimal efficiency, reproducibility, and scalability for our clients. This expertise is especially critical when dealing with complex APIs. Pharmaceutical companies typically know the chemical properties of their compounds, but once those materials are transformed into powders, their physical behavior becomes a real challenge. That’s where Munit steps in. Our specialized know-how bridges this gap, ensuring particle size and consistency are precisely controlled, directly impacting solubility, bioavailability, and ultimately patient outcomes. By combining scientific insight, technical know-how, and a quality-by-design mindset, we give our clients confidence that every process is optimized for efficiency, reliability, and patient benefit. HIGHLIGHTS// Customize process to needs of each API/dealing with complex APIs/combining science with technical knowhow/quality-by-design mindset With operations in both Switzerland and Italy, how do Munit’s dual sites contribute to reducing supply chain risk, lead times, or overall costs for clients? Our dual sites in Switzerland and Italy give Munit a unique edge in supply chain resilience, flexibility, and cost efficiency. Recent investments — tripling Microchem’s footprint and expanding Jetpharma’s GMP warehouse capacity — enable us to handle growing demand while keeping lead times competitive. But infrastructure alone is not enough. By harmonizing quality systems, aligning operational standards, and driving a tailored digital transformation, we ensure that even the most complex APIs are managed with the highest reliability and efficiency. This integration across sites allows us to deliver the lean, responsive manufacturing that major pharma partners expect, while reducing risks and strengthening long-term partnerships. HIGHLIGHTS// Supply chain resilience comes from dual sites/managing complex APIs with reliability, efficiency/long-term partnerships

    Impressions: 1547

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    https://www.pharmacompass.com/speak-pharma/we-bridge-the-gap-between-chemistry-and-performance-to-deliver-precise-optimized-micronization-for-complex-apis

    PharmaCompass
    01 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: 405

    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: 6621

    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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    Alembic Pharma Receives USFDA Approval For Generic Depression
    Alembic Pharma Receives USFDA Approval For Generic Depression

    25 Sep 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-usfda-nod-for-generic-drug-to-treat-depression-anxiety/articleshow/124110588.cms

    ECONOMICTIMES
    25 Sep 2025
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    Alembic Pharma Gets EIR for API-I & API-II Panelav Facilities
    Alembic Pharma Gets EIR for API-I & API-II Panelav Facilities

    14 Sep 2025

    // EXPRESS PHARMA

    https://www.expresspharma.in/alembic-pharma-gets-eir-for-its-api-i-api-ii-facility-located-at-panelav/#:~:text=Alembic%20Pharmaceuticals%20has%20received%20the,2025%20and%20May%2031%2C%202025.

    EXPRESS PHARMA
    14 Sep 2025
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    Alembic Receives FDA Final Approval for Phytonadione Injectable
    Alembic Receives FDA Final Approval for Phytonadione Injectable

    10 Sep 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/alembic-gets-fda-final-approval-for-phytonadione-injectable-emulsion-usp-1-mg05-ml-single-dose-prefilled-syringe-17763

    INDPHARMAPOST
    10 Sep 2025
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    Alembic`s Generics Phytonadione Receives Approval in US
    Alembic`s Generics Phytonadione Receives Approval in US

    08 Sep 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216444

    FDA
    08 Sep 2025
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    Alembic’s Generics Melphalan Gets Tentative Approval in US
    Alembic’s Generics Melphalan Gets Tentative Approval in US

    25 Aug 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212810

    FDA
    25 Aug 2025
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    Alembic Gets USFDA Approval for 10mg Macitentan Tablets
    Alembic Gets USFDA Approval for 10mg Macitentan Tablets

    19 Aug 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/alembic-receives-usfda-final-approval-for-macitentan-tablets-10-mg-17626

    INDPHARMAPOST
    19 Aug 2025
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Azithromycin Dihydrate

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

    World Dairy Expo
    Not Confirmed
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    Azithromycin Dihydrate

    India

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

    arrow
    World Dairy Expo
    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 : 2016-02-12

    Pay. Date : 2016-01-28

    DMF Number : 20754

    Submission : 2007-07-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-165 - Rev 04

    Issue Date : 2022-04-06

    Type : Chemical

    Substance Number : 1649

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10146

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2024-11-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 46708-866

    Start Marketing Date : 2011-01-03

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Fenofibrate

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

    World Dairy Expo
    Not Confirmed
    arrow

    Fenofibrate

    India

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

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    World Dairy Expo
    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 : 2013-01-11

    Pay. Date : 2012-12-05

    DMF Number : 16208

    Submission : 2002-10-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-017 - Rev 00

    Issue Date : 2021-11-19

    Type : Chemical

    Substance Number : 1322

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10151

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : 20240116-209-J-1595(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City: Panelav, Dist: Panchmahal, Gujarat State, 389 350, India

     VMF Others AUDIT
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    03

    Lamotrigine

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

    World Dairy Expo
    Not Confirmed
    arrow

    Lamotrigine

    India

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

    arrow
    World Dairy Expo
    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 : 2013-03-15

    Pay. Date : 2013-02-26

    DMF Number : 18732

    Submission : 2005-09-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-010 - Rev 05

    Issue Date : 2025-02-03

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10012

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2017-01-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0081

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Olmesartan Medoxomil

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

    World Dairy Expo
    Not Confirmed
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    Olmesartan Medoxomil

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-07

    Pay. Date : 2013-09-26

    DMF Number : 24671

    Submission : 2011-02-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-297 - Rev 01

    Issue Date : 2023-05-12

    Type : Chemical

    Substance Number : 2600

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10284

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2015-12-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0083

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2014-03-18

    Registration Number : Su4579-2-ND

    Manufacturer Name : Alembic Pharmaceuticals Limited@[Manufacturer of starting material (Trityl Olmesartan Medoxomil)] Zhejiang Huahai Pharmaceutical Co., Ltd.

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, India.@Chuannan, Duqiao, Linhai, Zhejiang, China

     VMF Others AUDIT
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    05

    Ropinirole Hydrochloride

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

    World Dairy Expo
    Not Confirmed
    arrow

    Ropinirole Hydrochloride

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19780

    Submission : 2006-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-227 - Rev 00

    Issue Date : 2023-08-09

    Type : Chemical

    Substance Number : 2604

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10173

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2016-08-29

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2023-10-25

    Registration Number : 20190104-209-J-175(1)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-I).

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India_x000D_

     VMF Others AUDIT
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    06

    Telmisartan

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

    World Dairy Expo
    Not Confirmed
    arrow

    Telmisartan

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-08

    Pay. Date : 2012-12-21

    DMF Number : 20285

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-217 - Rev 07

    Issue Date : 2022-05-16

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10053

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-02-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Leaders Bio Co., Ltd.

    Registration Date : 2019-05-15

    Registration Number : 20180814-209-J-191(3)

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-1)

    Manufacturer Address : AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India

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    07

    Vardenafil Hydrochloride

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

    World Dairy Expo
    Not Confirmed
    arrow

    Vardenafil Hydrochloride

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-20

    Pay. Date : 2014-12-24

    DMF Number : 28900

    Submission : 2014-12-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-095 - Rev 01

    Issue Date : 2023-06-26

    Type : Chemical

    Substance Number : 2782

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10002

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2019-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Mpeak Korea Co., Ltd.

    Registration Date : 2018-02-22

    Registration Number : 20180222-211-J-181

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-III)

    Manufacturer Address : Plot No. 842-843, Taluka-Padra, City : Karakhadi - 391 450, District-Vadodara Gujarat State, India

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    08

    Venlafaxine Hydrochloride

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

    World Dairy Expo
    Not Confirmed
    arrow

    Venlafaxine Hydrochloride

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16551

    Submission : 2003-04-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-225 - Rev 05

    Issue Date : 2024-01-29

    Type : Chemical

    Substance Number : 2119

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10131

    Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India

    Initial Date of Registration : 2022-09-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Market
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    09

    Leflunomide

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

    World Dairy Expo
    Not Confirmed
    arrow

    Leflunomide

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16112

    Submission : 2002-08-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-172 - Rev 03

    Issue Date : 2025-06-30

    Type : Chemical

    Substance Number : 2330

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-08

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0081

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 46708-848

    Start Marketing Date : 2010-06-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Zmax Pharmachem Co., Ltd.

    Registration Date : 2022-04-25

    Registration Number : 20220425-209-J-1225

    Manufacturer Name : Alembic Pharmaceuticals Limited (API Division Panelav)

    Manufacturer Address : AT-Panelav, Tal-Halol, City. Panelav, Dist.-Panchmahal, Gujarat State, India

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    10

    Modafinil

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

    World Dairy Expo
    Not Confirmed
    arrow

    Modafinil

    India

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

    arrow
    World Dairy Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16477

    Submission : 2003-03-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-073 - Rev 00

    Issue Date : 2021-01-14

    Type : Chemical

    Substance Number : 2307

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-22

    Valid Till : 2028-08-21

    Written Confirmation Number : WC-0082

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    6-aminopenicillanic Acid

    India
    World Dairy Expo
    Not Confirmed
    arrow

    02

    Acalabrutinib

    India
    World Dairy Expo
    Not Confirmed
    arrow

    03

    Afatinib Dimaleate

    India
    World Dairy Expo
    Not Confirmed
    arrow

    04

    Alendronate Sodium Usp

    India
    World Dairy Expo
    Not Confirmed
    arrow

    05

    Alogliptin Benzoate

    India
    World Dairy Expo
    Not Confirmed
    arrow

    06

    Amantadine Hydrochloride Usp

    India
    World Dairy Expo
    Not Confirmed
    arrow

    07

    Apalutamide

    India
    World Dairy Expo
    Not Confirmed
    arrow

    08

    Apixaban

    India
    World Dairy Expo
    Not Confirmed
    arrow

    09

    Apremilast

    India
    World Dairy Expo
    Not Confirmed
    arrow

    10

    Apremilast (form-b)

    India
    World Dairy Expo
    Not Confirmed
    arrow
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    ABOUT THIS PAGE

    Contact Alembic Pharmaceuticals Limited and get a quotation

    Alembic Pharmaceuticals Limited is a supplier offers 235 products (APIs, Excipients or Intermediates).

    Find a price of Azithromycin Dihydrate bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Fenofibrate bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Lamotrigine bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Olmesartan Medoxomil bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Ropinirole Hydrochloride bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Telmisartan bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Vardenafil Hydrochloride bulk with DMF, CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Venlafaxine Hydrochloride bulk with CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Apixaban bulk with DMF, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Aripiprazole bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Bosutinib bulk with DMF, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Celecoxib bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Clonidine bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Deferasirox bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Donepezil bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Duloxetine Hydrochloride bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Erythromycin bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Febuxostat bulk with DMF, JDMF, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Fenofibrate bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Fingolimod Hydrochloride bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Fluoxetine Hydrochloride bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Fluphenazine bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Gefitinib bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Hydrochlorothiazide bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Irbesartan bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Leflunomide bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Linagliptin bulk with DMF, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Losartan Potassium bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Memantine Hydrochloride bulk with DMF, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Mexiletine bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Modafinil bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Nitrofurantoin bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Pirfenidone bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Pramipexole Dihydrochloride bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Roxithromycin bulk with CEP, JDMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Solifenacin Succinate bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Tadalafil bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Warfarin Sodium bulk with DMF, CEP, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Acalabrutinib bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Afatinib bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Alogliptin Benzoate bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Apalutamide bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Apremilast bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

    Find a price of Asenapine Maleate bulk with DMF, WC offered by Alembic Pharmaceuticals Limited

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    Find a price of Azithromycin bulk with CEP offered by Alembic Pharmaceuticals Limited

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    Find a price of CAS 284461-73-0 bulk with CEP offered by Alembic Pharmaceuticals Limited

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