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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]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    12 Mar 2025
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    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    Artificial intelligence (AI) is emerging as a transformative force in drug discovery and development. The global AI in drug discovery market was valued at US$ 1.99 billion in 2024 and is estimated to reach US$ 2.65 billion in 2025. Going forward, the market is expected to grow at an impressive compounded annual growth rate (CAGR) of 29.6 percent, to reach a market size of US$ 35.42 billion by 2034, says a report by Polaris Market Research. This growth expectation mirrors the eagerness within the biopharma industry to leverage AI in order to overcome the traditional barriers of lengthy timelines, exorbitant costs, and high failure rates. This eagerness is also being manifested in deal making — Big Pharma has been busy forging alliances with AI-driven drug discovery companies. Over the last two years, almost every big drugmaker, including Novo Nordisk, Merck, BMS, Pfizer, AstraZeneca, Otsuka Pharmaceutical, Novartis and Sanofi, has signed deals with various AI drug discovery companies. PharmaCompass' compilation shows there are scores of molecules discovered by AI currently in discovery and developmental phases, demonstrating the technology's growing impact on pharmaceutical pipelines.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available) Novo, Lilly, BMS invest in AI partnerships; Recursion, Exscientia merge to create AI powerhouse With the transformative potential of AI becoming increasingly evident, we witnessed a slew of deals in the biopharma industry over the last six months. A significant deal in the AI drug discovery space was the merger of two leaders — Recursion and Exscientia — that took place in November last year. Exscientia is now a wholly-owned subsidiary of Recursion. The merger has created a global technology-enabled drug discovery leader with end-to-end capabilities. The merged entity has over 10 clinical and preclinical programs, and around 10 advanced discovery programs in the pipeline.  Apart from this merger, several large drugmakers have struck deals with AI drug discovery firms since September last year. For instance, in January this year, Valo Health and Novo Nordisk expanded their collaboration to discover and develop novel treatments for cardiometabolic diseases. This deal, valued at up to US$ 4.8 billion, aims to harness the power of AI and extensive human datasets. Building on their initial 2023 partnership, it will enable the development of up to 20 drug programs.  Similarly, Pfizer, which is already big on AI, extended its AI drug discovery pact with PostEra and also partnered IgnitionAI to enhance drug discovery — all within the last six months. And Novartis struck a drug discovery deal with Generate BioMedicines in September. Insilico Medicine has been actively forging partnerships. In January, Insilico entered a second exclusive global license agreement with Menarini Group for an AI-discovered preclinical asset targeting high unmet needs in oncology. Insilico also has a tie-up with Sanofi, dating back to 2022. In December 2024, AI Proteins announced a research collaboration and option agreement with BMS to design and optimize mini-proteins for therapeutic use. And in September, Eli Lilly joined hands with Genetic Leap to accelerate the development of genetic medicines. Lilly will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against selected targets.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  AI leads to faster target identification; Insilico, BenevolentAI’s candidates in trials Computational biology, and especially AI, has fundamentally changed the drug discovery paradigm. The traditional method of drug discovery used to take 13 to 15 years, costing an average of US$ 2.5 billion in investment before a drug got approved and launched in the market. Additionally, less than 10 percent of candidates in phase 1 clinical trials used to end up getting approved by the US Food and Drug Administration (FDA). All that has begun to change. According to Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, since 2016, FDA has received approximately 300 submissions that reference AI use as of May 2024. These submissions range from drug development, drug discovery, clinical research, clinical trials as well as post-market safety surveillance and manufacturing. Though we are yet to witness an AI-generated candidate translate into an approved therapy, target identification in drug discovery is visibly becoming a lot faster. This is the process that identifies specific molecules or pathways in the human body that are linked to a disease. The best example of dramatic acceleration of timelines is Insilico Medicine’s development of INS018_055, a candidate for idiopathic pulmonary fibrosis that entered phase 2 trials in June 2023. Using their AI platform PandaOmics, researchers at Insilico compressed target identification from years to just 18 months. Similarly, BenevolentAI successfully employed their AI platform to identify a new target for ulcerative colitis, leading to the development of BEN-8744, a candidate that has been in phase 1a clinical trials since August 2023.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Oncology leads AI drug discovery market; Recursion shows how to repurpose drugs using AI The integration of AI in oncology research has been impactful, accounting for the largest revenue share (about 22.4 percent) in the AI drug discovery market in 2023. AI technologies have accelerated the discovery and development of new cancer treatments, bolstered personalized medicine approaches, and improved clinical trial designs in the arena of this complex disease.  Another promising application is drug repurposing, where AI can identify new therapeutic applications for existing drugs. Recursion Pharmaceuticals’ REC-2282 exemplifies this approach. This therapy is currently in phase 2/3 studies for neurofibromatosis type 2 (a genetic condition that causes tumors to grow along nerves). By repurposing compounds already vetted for safety, this strategy can bypass early-stage failures, reducing both time and cost compared to developing entirely new molecules. However, the use of AI in drug discovery is not without challenges. Exscientia’s EXS-21546, designed to treat solid tumors, entered phase 1/2 trials in 2020 but was discontinued in 2023 after modeling suggested that achieving a suitable therapeutic index would be difficult. Though this is a clinical failure, it highlights AI’s value in identifying potential failures earlier on in the development process, saving resources that would have otherwise been spent on later-stage trials.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Our view The Covid-19 pandemic was a time when humanity felt the urgent need to speed up the process of drug discovery, testing and approvals. It also hastened the process of integrating AI into pharmaceutical research, leading to the launch of Covid vaccines in record time. Today, there is no looking back — AI is bringing about a paradigm shift in how drugs are discovered. With increasing reliance on AI, there is hope that drug discovery will be more accurate, efficient and less time and cost consuming.
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    Impressions: 535

    https://www.pharmacompass.com/radio-compass-blog/ai-drug-discovery-market-to-grow-30-cagr-to-reach-us-35-bn-by-2034-novo-lilly-bms-forge-deals

    #PharmaFlow by PHARMACOMPASS
    13 Mar 2025
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    NEWS #PharmaBuzz

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    Boehringer wins jury verdict in Zantac retrial in Illinois
    Boehringer wins jury verdict in Zantac retrial in Illinois

    26 Feb 2025

    // ENDPTS

    https://endpts.com/boehringer-ingelheim-wins-jury-verdict-in-zantac-retrial-in-illinois/

    ENDPTS
    26 Feb 2025
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    CDR-Life Hits Fifth Milestone With Boehringer In Geographic Atrophy
    CDR-Life Hits Fifth Milestone With Boehringer In Geographic Atrophy

    25 Feb 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250225492391/en

    BUSINESSWIRE
    25 Feb 2025
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    Boehringer Ingelheim launches new trivalent poultry vaccine
    Boehringer Ingelheim launches new trivalent poultry vaccine

    24 Feb 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/02/24/3030917/0/en/Boehringer-Ingelheim-launches-new-trivalent-poultry-vaccine-includes-protection-against-H5-avian-influenza.html

    GLOBENEWSWIRE
    24 Feb 2025
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    OXB’s Lentiviral Tech Supports Boehringer’s Ph 1/2 CF Gene Therapy Trial
    OXB’s Lentiviral Tech Supports Boehringer’s Ph 1/2 CF Gene Therapy Trial

    20 Feb 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/02/20/3029669/0/en/OXB-s-lentiviral-vector-manufacturing-technology-to-support-Boehringer-Ingelheim-s-newly-initiated-Phase-I-II-trial-of-first-in-class-gene-therapy-for-cystic-fibrosis.html

    GLOBENEWSWIRE
    20 Feb 2025
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    Boehringer, Partner Begin Clinical Trial For Inhaled CF Gene Therapy
    Boehringer, Partner Begin Clinical Trial For Inhaled CF Gene Therapy

    20 Feb 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/02/20/3029558/0/en/Boehringer-Ingelheim-and-partners-start-clinical-development-of-a-first-in-class-inhaled-gene-therapy-for-people-with-cystic-fibrosis.html

    GLOBENEWSWIRE
    20 Feb 2025
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    Boehringer Ingelheim Welcomes Brian As US Pharma President
    Boehringer Ingelheim Welcomes Brian As US Pharma President

    20 Feb 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/boehringer-ingelheim-pharmaceuticals-inc-welcomes-brian-hilberdink-as-president-us-human-pharma-302380906.html

    PR NEWSWIRE
    20 Feb 2025
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    ALL APIs

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    01

    Epinastine Hydrochloride

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

    European Pharma Congress
    Not Confirmed
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    Epinastine Hydrochloride

    Germany

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

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    European Pharma Congress
    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 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

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    02

    Ipratropium Bromide

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

    European Pharma Congress
    Not Confirmed
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    Ipratropium Bromide

    Germany

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14259

    Submission : 1999-06-25

    Status : Active

    Type : II

     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 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

     VMF Others AUDIT
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    03

    Repaglinide

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

    European Pharma Congress
    Not Confirmed
    arrow

    Repaglinide

    Germany

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 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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    04

    Ambroxol Hydrochloride

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

    European Pharma Congress
    Not Confirmed
    arrow

    Ambroxol Hydrochloride

    Italy

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

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    European Pharma Congress
    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

     VMF Others AUDIT
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    05

    Digoxin

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

    European Pharma Congress
    Not Confirmed
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    Digoxin

    Germany

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
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    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6926

    Submission : 1987-04-06

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2000-147 - Rev 04

    Issue Date : 2015-09-25

    Type : Chemical

    Substance Number : 79

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 218MF10484

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

    Initial Date of Registration : 2006-05-15

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    06

    Epinephrine

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

    European Pharma Congress
    Not Confirmed
    arrow

    Epinephrine

    Germany

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

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    European Pharma Congress
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5822

    Submission : 1985-05-29

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2009-274 - Rev 00

    Issue Date : 2016-03-17

    Type : Chemical

    Substance Number : 2303

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 218MF10483

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

    Initial Date of Registration : 2006-05-15

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    Ketoprofen

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

    European Pharma Congress
    Not Confirmed
    arrow

    Ketoprofen

    Italy

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

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    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18148

    Submission : 2005-02-21

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2002-010 - Rev 02

    Issue Date : 2010-07-08

    Type : Chemical

    Substance Number : 922

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 218MF10395

    Registrant's Address : S. S. 11 Padana Superior N. 8 24040 Fornovo S. Giovanni BG Italy

    Initial Date of Registration : 2006-03-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    Pramipexole Dihydrochloride

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

    European Pharma Congress
    Not Confirmed
    arrow

    Pramipexole Dihydrochloride

    Germany

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

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    European Pharma Congress
    Not Confirmed
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    USDMF arrow-down
    ✖

    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 : R0-CEP 2019-186 - Rev 00

    Issue Date : 2020-04-02

    Type : Chemical

    Substance Number : 2416

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea 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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    09

    Salbutamol Sulphate

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

    European Pharma Congress
    Not Confirmed
    arrow

    Salbutamol Sulphate

    Germany

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

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    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    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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    10

    Scopolamine Hydrobromide

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

    European Pharma Congress
    Not Confirmed
    arrow

    Scopolamine Hydrobromide

    Germany

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

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    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3622

    Submission : 1979-08-23

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2000-064 - Rev 01

    Issue Date : 2008-09-09

    Type : Chemical

    Substance Number : 106

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 221MF10105

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

    Initial Date of Registration : 2009-05-27

    Latest Date of Registration :

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

    Drugs in Development

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    OXB’s Technology to Support Boehringer’s Gene Therapy for Cystic Fibrosis

    Details:

    BI 3720931 is a first-in-class, inhaled lentiviral vector-based gene therapy designed to insert a functional copy of the CFTR gene in the DNA of airway epithelial cells for treating cystic fibrosis.


    Lead Product(s): BI 3720931

    Therapeutic Area: Genetic Disease Brand Name: BI 3720931

    Study Phase: Phase I/ Phase IIProduct Type: Cell and Gene therapy

    Sponsor: OXB

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 20, 2025

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    01

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
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    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed
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    Lead Product(s) : BI 3720931

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : OXB

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    OXB’s Technology to Support Boehringer’s Gene Therapy for Cystic Fibrosis

    Details : BI 3720931 is a first-in-class, inhaled lentiviral vector-based gene therapy designed to insert a functional copy of the CFTR gene in the DNA of airway epithelial cells for treating cystic fibrosis.

    Product Name : BI 3720931

    Product Type : Cell and Gene therapy

    Upfront Cash : Inapplicable

    February 20, 2025

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    Zongertinib Receives Priority Review for HER2 (ERBB2)-mutant Advanced NSCLC

    Details:

    BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.


    Lead Product(s): Zongertinib

    Therapeutic Area: Oncology Brand Name: BI 1810631

    Study Phase: Phase IProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 19, 2025

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    02

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed
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    Lead Product(s) : Zongertinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zongertinib Receives Priority Review for HER2 (ERBB2)-mutant Advanced NSCLC

    Details : BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.

    Product Name : BI 1810631

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 19, 2025

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    Boehringer’s Nerandomilast Hits Primary Endpoint in Phase III FIBRONEER-ILD

    Details:

    BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF.


    Lead Product(s): Nerandomilast

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: BI 1015550

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 10, 2025

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    03

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed
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    Lead Product(s) : Nerandomilast

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Boehringer’s Nerandomilast Hits Primary Endpoint in Phase III FIBRONEER-ILD

    Details : BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for IPF.

    Product Name : BI 1015550

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 10, 2025

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    Boehringer Widens Fibrosis Drug's Potential After 2nd Ph. 3 Win

    Details:

    BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for progressive pulmonary fibrosis.


    Lead Product(s): Nerandomilast

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: BI 1015550

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 10, 2025

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    04

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Nerandomilast

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Boehringer Widens Fibrosis Drug's Potential After 2nd Ph. 3 Win

    Details : BI 1015550 (nerandomilast) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for progressive pulmonary fibrosis.

    Product Name : BI 1015550

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 10, 2025

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    Boehringer Provides Update on Iclepertin Phase III Program in Schizophrenia

    Details:

    BI 425809(iclepertin), an investigational oral inhibitor of glycine transporter 1 (GlyT1), studied as a potential treatment for cognitive impairment in adults with schizophrenia.


    Lead Product(s): Iclepertin

    Therapeutic Area: Neurology Brand Name: BI 425809

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 16, 2025

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    05

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed
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    Lead Product(s) : Iclepertin

    Therapeutic Area : Neurology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Boehringer Provides Update on Iclepertin Phase III Program in Schizophrenia

    Details : BI 425809(iclepertin), an investigational oral inhibitor of glycine transporter 1 (GlyT1), studied as a potential treatment for cognitive impairment in adults with schizophrenia.

    Product Name : BI 425809

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 16, 2025

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    Boehringer's Schizophrenia Drug Fails Trio of Phase 3 Trials

    Details:

    BI 425809 (iclepertin) is a glycine transporter 1 (GlyT1) inhibitor, small molecule drug candidate, which is being evaluated for the treatment of patients with schizophrenia.


    Lead Product(s): Iclepertin

    Therapeutic Area: Psychiatry/Psychology Brand Name: BI 425809

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 16, 2025

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    06

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Iclepertin

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Boehringer's Schizophrenia Drug Fails Trio of Phase 3 Trials

    Details : BI 425809 (iclepertin) is a glycine transporter 1 (GlyT1) inhibitor, small molecule drug candidate, which is being evaluated for the treatment of patients with schizophrenia.

    Product Name : BI 425809

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 16, 2025

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    Boehringer Ingelheim Acquires License for Novel Antibody Cancer Treatments

    Details:

    Under the expanded collaboration agreement, Boehringer Ingelheim will be responsible for the future development and commercialization of antibody products for the Cancer.


    Lead Product(s): Undisclosed

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: DiscoveryProduct Type: Antibody-drug Conjugate

    Recipient: Oxford Biotherapeutics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Expanded Collaboration January 09, 2025

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    07

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
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    Boehringer Ingelheim GmbH

    Germany
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    Lead Product(s) : Undisclosed

    Therapeutic Area : Oncology

    Highest Development Status : Discovery

    Recipient : Oxford Biotherapeutics

    Deal Size : Undisclosed

    Deal Type : Expanded Collaboration

    DEALS_DEV arrow-down

    Boehringer Ingelheim Acquires License for Novel Antibody Cancer Treatments

    Details : Under the expanded collaboration agreement, Boehringer Ingelheim will be responsible for the future development and commercialization of antibody products for the Cancer.

    Product Name : Undisclosed

    Product Type : Antibody-drug Conjugate

    Upfront Cash : Undisclosed

    January 09, 2025

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    Sutro, Boehringer Partner on Cell-Free Biopharma Manufacturing Scale-Up

    Details:

    The collaboration aims to commercial scale to manufacture Luvelta (luveltamab tazevibulin), Sutro’s Tubulin FRα-targeting ADC designed to treat a broad range of patients with ovarian cancer.


    Lead Product(s): Luveltamab Tazevibulin,Pegfilgrastim

    Therapeutic Area: Oncology Brand Name: Luvelta

    Study Phase: Phase II/ Phase IIIProduct Type: Antibody-drug Conjugate

    Recipient: Sutro Biopharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration January 07, 2025

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    08

    Boehringer Ingelheim GmbH

    Germany
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    Boehringer Ingelheim GmbH

    Germany
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    Lead Product(s) : Luveltamab Tazevibulin,Pegfilgrastim

    Therapeutic Area : Oncology

    Highest Development Status : Phase II/ Phase III

    Recipient : Sutro Biopharma

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Sutro, Boehringer Partner on Cell-Free Biopharma Manufacturing Scale-Up

    Details : The collaboration aims to commercial scale to manufacture Luvelta (luveltamab tazevibulin), Sutro’s Tubulin FRα-targeting ADC designed to treat a broad range of patients with ovarian cancer.

    Product Name : Luvelta

    Product Type : Antibody-drug Conjugate

    Upfront Cash : Undisclosed

    January 07, 2025

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    Malaysia Approves Spesolimab for Generalised Pustular Psoriasis Flares in Adults

    Details:

    Spevigo (spesolimab) is an IL-36 blocker, given by IV infusion, has been approved by CDSCO as the first treatment option for generalized pustular psoriasis flares in adults.


    Lead Product(s): Spesolimab

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 13, 2024

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    09

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
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    Germany
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    Lead Product(s) : Spesolimab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Malaysia Approves Spesolimab for Generalised Pustular Psoriasis Flares in Adults

    Details : Spevigo (spesolimab) is an IL-36 blocker, given by IV infusion, has been approved by CDSCO as the first treatment option for generalized pustular psoriasis flares in adults.

    Product Name : Undisclosed

    Product Type : Large molecule

    Upfront Cash : Not Applicable

    December 13, 2024

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    Torrent Pharma Inks Agreement with Boehringer Ingelheim to Acquire 3 Anti-Diabetes Brands

    Details:

    The acquisition strengthens Torrent’s existing diabetes portfolio by adding Cospiaq (empagliflozin), Cospiaq Met (empagliflozin & metformin) and Xilingio (empagliflozin & linagliptin) from Boehringer.


    Lead Product(s): Empagliflozin

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Torrent Pharmaceuticals Limited

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition December 04, 2024

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    10

    Boehringer Ingelheim GmbH

    Germany
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    Natural Products Expo
    Not Confirmed

    Boehringer Ingelheim GmbH

    Germany
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    Not Confirmed
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    Lead Product(s) : Empagliflozin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Torrent Pharmaceuticals Limited

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Torrent Pharma Inks Agreement with Boehringer Ingelheim to Acquire 3 Anti-Diabetes Brands

    Details : The acquisition strengthens Torrent’s existing diabetes portfolio by adding Cospiaq (empagliflozin), Cospiaq Met (empagliflozin & metformin) and Xilingio (empagliflozin & linagliptin) from Boehringer.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    December 04, 2024

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    FDF Dossiers

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    01

    Brand Name : ATRAVET 10 MG INJECT...

    Germany
    Bio-Europe Spring
    Not Confirmed
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    Brand Name : ATRAVET 10 MG INJECT...

    Germany
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    Bio-Europe Spring
    Not Confirmed
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    Regulatory Info :

    Registration Country : Canada

    ACEPROMAZINE MALEATE

    Boehringer Ingelheim GmbH

    Dosage Form : SOLUTION

    Brand Name : ATRAVET 10 MG INJECTABLE

    Dosage Strength : 10MG/ML

    Packaging : 50 ML

    Approval Date :

    Application Number : 53023

    Regulatory Info :

    Registration Country : Canada

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    02

    Brand Name : Zerinetta C.M.

    Germany
    Mental Health
    Not Confirmed
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    Brand Name : Zerinetta C.M.

    Germany
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    Mental Health
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Acetaminophen/Paracetamol; Chlorpheniramine

    Boehringer Ingelheim GmbH

    Dosage Form :

    Brand Name : Zerinetta C.M.

    Dosage Strength : 10 Supp 150 Mg + 1 Mg ...

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    Bio-Europe Spring
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    Bio-Europe Spring
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 300MG;30MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84656

    Regulatory Info : DISCN

    Registration Country : USA

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    04

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    Bio-Europe Spring
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    Bio-Europe Spring
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 300MG;60MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84667

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    DCAT Week
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    DCAT Week
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 500MG;30MG

    Packaging :

    Approval Date : 1989-04-25

    Application Number : 89512

    Regulatory Info : DISCN

    Registration Country : USA

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    06

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    NeuroForum
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    NeuroForum
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 300MG;15MG

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 84659

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    DCAT Week
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    DCAT Week
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 500MG;15MG

    Packaging :

    Approval Date : 1989-04-25

    Application Number : 89511

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
    NeuroForum
    Not Confirmed
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    Brand Name : ACETAMINOPHEN AND CO...

    U.S.A
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    NeuroForum
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; CODEINE PHOSPHATE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND CODEINE...

    Dosage Strength : 500MG;60MG

    Packaging :

    Approval Date : 1989-04-25

    Application Number : 89513

    Regulatory Info : DISCN

    Registration Country : USA

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    Market
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    09

    Brand Name : ROXICET 5/500

    U.S.A
    DCAT Week
    Not Confirmed
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    Brand Name : ROXICET 5/500

    U.S.A
    arrow
    DCAT Week
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    ROXANE

    Dosage Form : TABLET;ORAL

    Brand Name : ROXICET 5/500

    Dosage Strength : 500MG;5MG

    Packaging :

    Approval Date : 1989-01-12

    Application Number : 89775

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Brand Name : ROXILOX

    U.S.A
    Bio-Europe Spring
    Not Confirmed
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    Brand Name : ROXILOX

    U.S.A
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    Bio-Europe Spring
    Not Confirmed
    • fda
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    ROXANE

    Dosage Form : CAPSULE;ORAL

    Brand Name : ROXILOX

    Dosage Strength : 500MG;5MG

    Packaging :

    Approval Date : 1995-07-03

    Application Number : 40061

    Regulatory Info : DISCN

    Registration Country : USA

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    Europe

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    01

    Brand Name : Zerinetta C.M.

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Zerinetta C.M.

    Germany
    arrow
    Bacteriophage Summit
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Acetaminophen/Paracetamol; Chlorpheniramine

    Boehringer Ingelheim GmbH

    Dosage Form :

    Dosage Strength : 10 Supp 150 Mg + 1 Mg ...

    Packaging :

    Brand Name : Zerinetta C.M.

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Afatinib 20Mg 28 Combined Oral...

    Dosage Strength : 28 cpr riv 20 mg

    Packaging :

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
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    Regulatory Info :

    Registration Country : Italy

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Afatinib 30Mg 28 Combined Oral...

    Dosage Strength : 28 cpr riv 30 mg

    Packaging :

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
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    Regulatory Info :

    Registration Country : Italy

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Afatinib 40Mg 28 Combined Oral...

    Dosage Strength : 28 cpr riv 40 mg

    Packaging :

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
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    Regulatory Info :

    Registration Country : Italy

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Afatinib 50Mg 28 Combined Oral...

    Dosage Strength : 28 cpr riv 50 mg

    Packaging :

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    06

    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
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    Regulatory Info :

    Registration Country : Norway

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 20 mg

    Packaging : Blister, endose

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Bacteriophage Summit
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    Regulatory Info :

    Registration Country : Norway

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 30 mg

    Packaging : Blister, endose

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : Giotrif

    Germany
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    Regulatory Info :

    Registration Country : Norway

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 40 mg

    Packaging : Blister, endose

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Brand Name : Giotrif

    Germany
    Bacteriophage Summit
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    Brand Name : Giotrif

    Germany
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    Regulatory Info :

    Registration Country : Norway

    afatinib

    Boehringer Ingelheim GmbH

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 50 mg

    Packaging : Blister, endose

    Brand Name : Giotrif

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Brand Name : GIOTRIF

    Germany
    Bacteriophage Summit
    Not Confirmed
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    Brand Name : GIOTRIF

    Germany
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    Regulatory Info :

    Registration Country : Sweden

    afatinibdimaleat

    Boehringer Ingelheim GmbH

    Dosage Form : FILM COATED PILL

    Dosage Strength : 20 MG

    Packaging :

    Brand Name : GIOTRIF

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    FDA

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    FDA Audited

    USA
    Natural Products Expo
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-26

    Boehringer Ingelheim GmbH

    City : Malgrat de Mar

    State :

    Country/Area : ES

    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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    FDA Audited

    USA
    Natural Products Expo
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    FDA Audited

    USA
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    Natural Products Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-17

    Boehringer Ingelheim GmbH

    City : Vienna

    State :

    Country/Area : AT

    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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    FDA Audited

    USA
    Natural Products Expo
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    FDA Audited

    USA
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    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-09-25

    Boehringer Ingelheim GmbH

    City : Malgrat de Mar

    State :

    Country/Area : ES

    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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    FDA Audited

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    Natural Products Expo
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    FDA Audited

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    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

    Boehringer Ingelheim GmbH

    City : Saint Joseph

    State : MO

    Country/Area : US

    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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    FDA Audited

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    FDA Audited

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    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-14

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : US

    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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    FDA Audited

    USA
    Natural Products Expo
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    FDA Audited

    USA
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    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-06-26

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : US

    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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    FDA Audited

    USA
    Natural Products Expo
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    FDA Audited

    USA
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    Natural Products Expo
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-23

    Boehringer Ingelheim GmbH

    City : Ingelheim Am Rhein

    State :

    Country/Area : DE

    Zip :

    District : ORA

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2015-01-23

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    FDA Audited

    USA
    Natural Products Expo
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    Natural Products Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-11-11

    Boehringer Ingelheim GmbH

    City : Vienna

    State :

    Country/Area : AT

    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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    FDA Audited

    USA
    Natural Products Expo
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    FDA Audited

    USA
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    Natural Products Expo
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-26

    Boehringer Ingelheim GmbH

    City : Columbus

    State : OH

    Country/Area : US

    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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    FDA Audited

    USA
    Natural Products Expo
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    Natural Products Expo
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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-06-12

    Boehringer Ingelheim GmbH

    City : Saint Joseph

    State : MO

    Country/Area : US

    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 86 products (APIs, Excipients or Intermediates).

    Find a price of Epinastine Hydrochloride bulk with DMF, CEP, JDMF offered by Boehringer Ingelheim GmbH

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    Find a price of Hyoscine Butyl Bromide bulk with CEP offered by Boehringer Ingelheim GmbH

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    Find a price of Clenbuterol Hydrochloride bulk with CEP offered by Boehringer Ingelheim GmbH

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    Find a price of Dihydroergotamine Mesylate bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Homatropine Methylbromide bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Methocarbamol bulk with DMF offered by Boehringer Ingelheim GmbH

    Find a price of Methylphenidate Hydrochloride bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Phenylephrine Hydrochloride bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Tramazoline Hydrochloride Monohydrate bulk with CEP offered by Boehringer Ingelheim GmbH

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    Find a price of Zolpidem Tartrate bulk offered by Boehringer Ingelheim GmbH

    Find a price of Medium / Medium Additives-P-Media bulk with JDMF offered by Boehringer Ingelheim GmbH

    Find a price of Beperuminogen per plasmid bulk with JDMF offered by Boehringer Ingelheim GmbH

    Find a price of Medium / Medium Additives / G-Medium bulk with JDMF offered by Boehringer Ingelheim GmbH

    Find a price of Medium / Medium Additives-I-Medium bulk with JDMF offered by Boehringer Ingelheim GmbH

    Find a price of Medium / Medium Additives ・ F-Media bulk with JDMF offered by Boehringer Ingelheim GmbH

    Find a price of Amphetamine bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Esmolol Hydrochloride bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Glycopyrronium Bromide bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Isoproterenol Hydrochloride bulk offered by Boehringer Ingelheim GmbH

    Find a price of L-Lactide bulk offered by Boehringer Ingelheim GmbH

    Find a price of Lanthanum Carbonate bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Methadol Hydrochloride bulk offered by Boehringer Ingelheim GmbH

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    Find a price of Theophylline bulk offered by Boehringer Ingelheim GmbH

    Find a price of Tiotropium Bromide bulk offered by Boehringer Ingelheim GmbH

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    Find a price of PRODUCTION AND DISTRIBUTION FACILITY IN DANBURY, CONNECTICUT bulk offered by Boehringer Ingelheim GmbH

    Find a price of NR-LU-10 MURINE MONOCLONAL ANTIBODY FAB FRAGMENT (NOFETUMOMAB) AND PHENTHIOATE LIGAND BULK MATERIAL FOR ONCOTRAC KIT (NEORX) bulk offered by Boehringer Ingelheim GmbH

    Find a price of COPOLYMERS OF TRIMETHYLENE CARBONATE WITHL- OR D,L-LACTIDE bulk offered by Boehringer Ingelheim GmbH

    Find a price of rTNF-alpha Drug Substance bulk offered by Boehringer Ingelheim GmbH

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    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN RIDGEFIELD, CONNECTICUT. bulk offered by Boehringer Ingelheim GmbH

    Find a price of PHYSOSTIGMINE SALICYLATE (SYNTHETIC bulk offered by Boehringer Ingelheim GmbH

    Find a price of INTERLEUKIN-12 BULK SUBSTANCE bulk offered by Boehringer Ingelheim GmbH

    Find a price of ESERETHOL bulk offered by Boehringer Ingelheim GmbH

    Find a price of POLY-(D,L-LACTIDE-CO-GLYCOLIDE) 50:50 bulk offered by Boehringer Ingelheim GmbH

    Find a price of Bromhexine Hydrochloride bulk offered by Boehringer Ingelheim GmbH

    Find a price of Penethamate Hydriodide bulk offered by Boehringer Ingelheim GmbH

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