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    Company profile for Boehringer Ingelheim GmbH

    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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

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    HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Aspen API. More than just an API™

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    FAMAR CDMO- From early development to commercial manufacturing.

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    About

    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept "Lead & Learn", this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim....
    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept "Lead & Learn", this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date.

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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: 1642

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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: 1601

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    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: 6685

    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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    ERS Data: Nerandomilast Lowers Death Risk in IPF, PPF
    ERS Data: Nerandomilast Lowers Death Risk in IPF, PPF

    30 Sep 2025

    // PHARMAWEB

    https://www.pharmiweb.com/press-release/2025-09-30/pooled-data-presented-at-ers-nerandomilast-monotherapy-linked-to-nominally-significant-reduction-in-risk-of-death-in-ipf-and-ppf

    PHARMAWEB
    30 Sep 2025
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    Boehringer Ingelheim Launches DTC Platform For Treatment Access
    Boehringer Ingelheim Launches DTC Platform For Treatment Access

    29 Sep 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/09/29/3157692/0/en/Boehringer-Ingelheim-launches-new-direct-to-consumer-platform-to-expand-patient-access-to-important-treatments.html

    GLOBENEWSWIRE
    29 Sep 2025
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    Novartis, Boehringer Debut DTC Programs With Reduced Drug Prices
    Novartis, Boehringer Debut DTC Programs With Reduced Drug Prices

    29 Sep 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/marketing/novartis-boehringer-dtc-platforms-slash-prices-cosentyx-spiriva-respimat

    FIERCE PHARMA
    29 Sep 2025
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    Numab Achieves Milestone in Collaboration with Boehringer
    Numab Achieves Milestone in Collaboration with Boehringer

    25 Sep 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/09/25/3156195/0/en/Numab-Therapeutics-Achieves-Milestone-in-Collaboration-with-Boehringer-Ingelheim.html

    GLOBENEWSWIRE
    25 Sep 2025
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    Palatin Gets €5.5M Milestone In Retinal Deal With Boehringer
    Palatin Gets €5.5M Milestone In Retinal Deal With Boehringer

    22 Sep 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/palatin-earns-5-5-million-6-5-million-milestone-payment-in-retinal-disease-collaboration-with-boehringer-ingelheim-302562035.html

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    22 Sep 2025
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    FDA Issues Over 100 Warnings in Ad Crackdown
    FDA Issues Over 100 Warnings in Ad Crackdown

    16 Sep 2025

    // RAPS

    https://www.raps.org/news-and-articles/news-articles/2025/9/fda-posts-more-than-100-warning-and-untitled-lette

    RAPS
    16 Sep 2025
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    ALL APIs

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    01

    Epinastine Hydrochloride

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

    The MedTech Conference
    Not Confirmed
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    Epinastine Hydrochloride

    Germany

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

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    The MedTech 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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15003

    Submission : 2000-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-311 - Rev 01

    Issue Date : 2021-03-17

    Type : Chemical

    Substance Number : 2411

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 224MF10100

    Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein

    Initial Date of Registration : 2012-05-23

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Co., Ltd.

    Registration Date : 2013-01-09

    Registration Number : 20130109-194-I-63-01

    Manufacturer Name : Boehringer Ingelheim GmbH & Co.KG

    Manufacturer Address : Binger Strasse 173 55216 Ingelheim am Rhein, Germany

     VMF Others AUDIT
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    Place

    02

    Repaglinide

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

    The MedTech Conference
    Not Confirmed
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    Repaglinide

    Germany

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

    arrow
    The MedTech 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.
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19620

    Submission : 2006-07-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-123 - Rev 00

    Issue Date : 2012-09-25

    Type : Chemical

    Substance Number : 2135

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10144

    Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein

    Initial Date of Registration : 2009-07-09

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Novo Nordisk Pharmaceuticals Co., Ltd.

    Registration Date : 2021-10-28

    Registration Number : 20211028-209-J-1132

    Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co KG

    Manufacturer Address : Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

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    03

    Ambroxol Hydrochloride

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

    The MedTech Conference
    Not Confirmed
    arrow

    Ambroxol Hydrochloride

    Italy

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

    arrow
    The MedTech 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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-142 - Rev 03

    Issue Date : 2011-02-10

    Type : Chemical

    Substance Number : 1489

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10085

    Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni

    Initial Date of Registration : 2008-03-18

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Opella Healthcare Korea Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-45-B-117-04

    Manufacturer Name : Bidachem SpA

    Manufacturer Address : SS 11(Padana Superiore), 8 24040 Fornovo San Giovanni

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    04

    Ipratropium Bromide

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

    The MedTech Conference
    Not Confirmed
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    Ipratropium Bromide

    Germany

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

    arrow
    The MedTech 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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-005 - Rev 05

    Issue Date : 2015-10-08

    Type : Chemical

    Substance Number : 919

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10081

    Registrant's Address : Binger Strasse 173,55216 Ingelheim am Rhein

    Initial Date of Registration : 2008-03-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12714-049

    Start Marketing Date : 2011-05-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Co., Ltd.

    Registration Date : 2012-09-19

    Registration Number : 20120919-188-I-64-01

    Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.

    Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhein

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    05

    Pramipexole Dihydrochloride

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

    The MedTech Conference
    Not Confirmed
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    Pramipexole Dihydrochloride

    Germany

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

    arrow
    The MedTech 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
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21413

    Submission : 2008-03-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-171 - Rev 00

    Issue Date : 2019-01-24

    Type : Chemical

    Substance Number : 2416

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Co., Ltd.

    Registration Date : 2022-05-17

    Registration Number : 20220517-209-J-1298

    Manufacturer Name : Boehringer Ingelheim Pharma GmbH & Co. K.G.

    Manufacturer Address : Binger Strasse 173, 55216 Ingelheim am Rhien, Germany

     VMF Others AUDIT
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    06

    Salbutamol Sulphate

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

    The MedTech Conference
    Not Confirmed
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    Salbutamol Sulphate

    Germany

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

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    The MedTech Conference
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14258

    Submission : 1999-06-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1997-004 - Rev 05

    Issue Date : 2024-05-30

    Type : Chemical

    Substance Number : 687

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
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    07

    Sodium Picosulfate

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

    The MedTech Conference
    Not Confirmed
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    Sodium Picosulfate

    Italy

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

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    The MedTech Conference
    Not Confirmed
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-068 - Rev 00

    Issue Date : 2009-11-04

    Type : Chemical

    Substance Number : 1031

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10132

    Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni

    Initial Date of Registration : 2008-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    Crotamiton

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

    The MedTech Conference
    Not Confirmed
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    Crotamiton

    Italy

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

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    The MedTech Conference
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15285

    Submission : 2001-02-08

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 1999-131 - Rev 03

    Issue Date : 2012-05-11

    Type : Chemical

    Substance Number : 1194

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Dipyridamole

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

    The MedTech Conference
    Not Confirmed
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    Dipyridamole

    Germany

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

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    The MedTech Conference
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13870

    Submission : 1998-11-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Meloxicam

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

    The MedTech Conference
    Not Confirmed
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    Meloxicam

    Italy

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

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    The MedTech Conference
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13846

    Submission : 1998-10-29

    Status : Active

    Type : II

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

    NDC Package Code : 51869-0007

    Start Marketing Date : 2000-06-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Co., Ltd.

    Registration Date : 2012-11-14

    Registration Number : 20121114-148-I-85-06

    Manufacturer Name : Bidachem SpA

    Manufacturer Address : Strada Statale 11(Padana Superiore), N. 8, 24040 Fornovo San Giovanni (BG), Italy

     VMF Others AUDIT
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    LISTED APIs

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    Bromhexine HCl

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    Market
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    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals...
    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date.
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    01

    Bromhexine HCl

    Germany
    The MedTech Conference
    Not Confirmed
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    Bromhexine HCl

    Germany
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    The MedTech Conference
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    Boehringer Ingelheim GmbH

    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date.

    About the Company : The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our ...

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    Penethamate hydroiodide

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    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals...
    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date.
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    02

    Penethamate hydroiodide

    Germany
    Fall Technical Meeting
    Not Confirmed
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    Penethamate hydroiodide

    Germany
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    Fall Technical Meeting
    Not Confirmed
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    Boehringer Ingelheim GmbH

    The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our corporate culture concept 'Lead & Learn', this vision is the driver of our corporate culture. Improving the health and quality of life of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date.

    About the Company : The Boehringer Ingelheim group of companies objectives and believes can be summed up in a single phrase: Value through Innovation, the central concept of our corporate vision. Together with our ...

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    01

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 300MG;30MG

    Approval Date : 1982-01-01

    Application Number : 84656

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 300MG;15MG

    Approval Date : 1982-01-01

    Application Number : 84659

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    • fda
    • EDQM
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 300MG;60MG

    Approval Date : 1982-01-01

    Application Number : 84667

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 500MG;15MG

    Approval Date : 1989-04-25

    Application Number : 89511

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 500MG;30MG

    Approval Date : 1989-04-25

    Application Number : 89512

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    06

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    The MedTech Conference
    Not Confirmed
    arrow
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND CODEIN...

    Dosage Strength : 500MG;60MG

    Approval Date : 1989-04-25

    Application Number : 89513

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    Brand Name : ROXILOX

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ROXILOX

    U.S.A
    The MedTech Conference
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    ROXANE

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : ROXILOX

    Dosage Strength : 500MG;5MG

    Approval Date : 1995-07-03

    Application Number : 40061

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    08

    Brand Name : ROXICET 5/500

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ROXICET 5/500

    U.S.A
    The MedTech Conference
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    ROXANE

    Dosage Form : TABLET; ORAL

    Proprietary Name : ROXICET 5/500

    Dosage Strength : 500MG;5MG

    Approval Date : 1989-01-12

    Application Number : 89775

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    Brand Name : ACETYLCYSTEINE

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETYLCYSTEINE

    U.S.A
    The MedTech Conference
    Not Confirmed
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    RLD : No

    TE Code :

    ACETYLCYSTEINE

    ROXANE

    Dosage Form : SOLUTION; INHALATION, ORAL

    Proprietary Name : ACETYLCYSTEINE

    Dosage Strength : 10%

    Approval Date : 1992-04-30

    Application Number : 72323

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    Brand Name : ACETYLCYSTEINE

    U.S.A
    The MedTech Conference
    Not Confirmed
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    Brand Name : ACETYLCYSTEINE

    U.S.A
    The MedTech Conference
    Not Confirmed
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    RLD : No

    TE Code :

    ACETYLCYSTEINE

    ROXANE

    Dosage Form : SOLUTION; INHALATION, ORAL

    Proprietary Name : ACETYLCYSTEINE

    Dosage Strength : 10%

    Approval Date : 1992-09-30

    Application Number : 72621

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-26

    Boehringer Ingelheim GmbH

    City : Malgrat de Mar

    State :

    Country/Area : Spain

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-26

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    02

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-17

    Boehringer Ingelheim GmbH

    City : Vienna

    State :

    Country/Area : Austria

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-17

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    03

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-25

    Boehringer Ingelheim GmbH

    City : Malgrat de Mar

    State :

    Country/Area : Spain

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-25

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    04

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : U.S.A

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

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    05

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

    Boehringer Ingelheim GmbH

    City : Saint Joseph

    State : MO

    Country/Area : U.S.A

    Zip : 64506-2002

    District : KAN

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

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    06

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-06-26

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : U.S.A

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-06-26

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    07

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-23

    Boehringer Ingelheim GmbH

    City : Ingelheim Am Rhein

    State :

    Country/Area : Germany

    Zip :

    District : ORA

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-23

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    08

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-11

    Boehringer Ingelheim GmbH

    City : Vienna

    State :

    Country/Area : Austria

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-11

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    09

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-26

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : U.S.A

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-26

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    10

    FDA Audited

    USA
    The MedTech Conference
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    The MedTech Conference
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-12

    Boehringer Ingelheim GmbH

    City : Saint Joseph

    State : MO

    Country/Area : U.S.A

    Zip : 64506-2002

    District : KAN

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-12

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    Contact Boehringer Ingelheim GmbH and get a quotation

    Boehringer Ingelheim GmbH is a supplier offers 48 products (APIs, Excipients or Intermediates).

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