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    About

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across...
    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph

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    Pfizer IncUnited_States_of_America Flag
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend  of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

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    https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases

    #SpeakPharma With Inke
    28 Oct 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    Impressions: 2489

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
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    NEWS #PharmaBuzz

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    Pfizer Reports Strong Q3 2024 Results and Raises Guidance
    Pfizer Reports Strong Q3 2024 Results and Raises Guidance

    29 Oct 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241029363831/en

    BUSINESSWIRE
    29 Oct 2024
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    Pfizer CEO Defends Turnaround Strategy Amid Activist Pressure
    Pfizer CEO Defends Turnaround Strategy Amid Activist Pressure

    29 Oct 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-raises-profit-forecast-after-beating-third-quarter-estimates-2024-10-29/

    REUTERS
    29 Oct 2024
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    Pfizer cranks up revenue outlook amid Paxlovid sales bump
    Pfizer cranks up revenue outlook amid Paxlovid sales bump

    29 Oct 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/pfizers-paxlovid-sales-lift-revenue-bump-profit-outlook-15b-amid-criticism-activist-investor

    FIERCE PHARMA
    29 Oct 2024
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    Pfizer lets its RSV pipeline dry up in crowded space
    Pfizer lets its RSV pipeline dry up in crowded space

    29 Oct 2024

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/pfizers-rsv-pipeline-runs-dry-work-halted-flu-combo-vaccine

    FIERCE BIOTECH
    29 Oct 2024
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    Analysts Rally Around Pfizer CEO Amid Starboard Challenge
    Analysts Rally Around Pfizer CEO Amid Starboard Challenge

    25 Oct 2024

    // BIOSPACE

    https://www.biospace.com/business/analysts-rally-around-pfizer-ceo-amid-starboard-challenge

    BIOSPACE
    25 Oct 2024
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    In boon for Pfizer and Merck, CDC panel backs expanded use of vaccines
    In boon for Pfizer and Merck, CDC panel backs expanded use of vaccines

    24 Oct 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/cdc-immunization-committee-votes-widen-recommendation-pneumococcal-vaccines-pfizer-merck

    FIERCE PHARMA
    24 Oct 2024
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    ALL APIs

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

    01

    Betamethyl Epoxide

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Betamethyl Epoxide

    U.S.A

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

    arrow
    SupplySide West 2024
    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 : 11848

    Submission : 1996-02-08

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2001-070 - Rev 00

    Issue Date : 2002-03-04

    Type : TSE

    Substance Number :

    Status : Expired

     JDMF arrow-down
    ✖

    Registration Number : 222MF10213

    Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

    Initial Date of Registration : 2010-08-05

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Epoprostenol Sodium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Epoprostenol Sodium

    U.S.A

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

    arrow
    SupplySide West 2024
    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 : 6065

    Submission : 1985-10-16

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10929

    Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

    Initial Date of Registration : 2006-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0009-5164

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    03

    Methylprednisolone

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Methylprednisolone

    U.S.A

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

    arrow
    SupplySide West 2024
    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 : 4796

    Submission : 1983-01-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-058 - Rev 03

    Issue Date : 2024-03-07

    Type : Chemical

    Substance Number : 561

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0009-0038

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    04

    Prednisolone

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Prednisolone

    U.S.A

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

    arrow
    SupplySide West 2024
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 1432

    Submission : 1969-09-18

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2001-018 - Rev 00

    Issue Date : 2001-10-24

    Type : TSE

    Substance Number :

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 227MF10238

    Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

    Initial Date of Registration : 2015-09-29

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    05

    Atorvastatin

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Atorvastatin

    U.S.A

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

    arrow
    SupplySide West 2024
    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22417

    Submission : 2009-01-29

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 301MF10022

    Registrant's Address : Little Island, Co. Cork, T45 F627, Ireland

    Initial Date of Registration : 2019-06-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 61947-0002

    Start Marketing Date : 2011-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : HKINNOEN Co., Ltd.

    Registration Date : 2019-09-24

    Registration Number : 20110110-132-H-57-04(1)

    Manufacturer Name : Upjohn Manufacturing Ireland Unlimited Company

    Manufacturer Address : Little Island, Co, Cork, T45 F627, Ireland

     VMF Others AUDIT
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    06

    Dexamethasone

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Dexamethasone

    U.S.A

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

    arrow
    SupplySide West 2024
    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 Inactive-api
    ✖

    Certificate Number : R0-CEP 2001-046 - Rev 00

    Issue Date : 2002-01-28

    Type : TSE

    Substance Number :

    Status : Expired

     JDMF arrow-down
    ✖

    Registration Number : 221MF10091

    Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

    Initial Date of Registration : 2009-05-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0009-5010

    Start Marketing Date : 2016-05-18

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2022-11-02

    Registration Number : 20220422-209-J-1258(1)

    Manufacturer Name : Pharmacia & Upjohn Company LLC

    Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

     VMF Others AUDIT
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    07

    Estradiol Cypionate

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

    SupplySide West 2024
    Not Confirmed
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    Estradiol Cypionate

    U.S.A

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

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    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5047

    Submission : 1983-07-25

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2000-394 - Rev 00

    Issue Date : 2001-11-05

    Type : TSE

    Substance Number :

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Estramustine Phosphate Sodium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Estramustine Phosphate Sodium

    U.S.A

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

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    SupplySide West 2024
    Not Confirmed
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 6258

    Submission : 1986-03-27

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2000-408 - Rev 00

    Issue Date : 2001-11-16

    Type : TSE

    Substance Number :

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Methylprednisolone Acetate

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Methylprednisolone Acetate

    U.S.A

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

    arrow
    SupplySide West 2024
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4813

    Submission : 1983-01-06

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2000-363 - Rev 00

    Issue Date : 2001-10-24

    Type : TSE

    Substance Number : 933

    Status : Withdrawn by Holder

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 0009-0026

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Paclitaxel

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Paclitaxel

    U.S.A

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

    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15079

    Submission : 2000-10-06

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 221MF10272

    Registrant's Address : 4876 Sterling Drive Boulder, CO 80301, USA

    Initial Date of Registration : 2009-12-09

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-68-A-132-02

    Manufacturer Name : Corden Pharma Boulder, Inc.

    Manufacturer Address : 4876 Sterling Drive, Boulder, Colorado (CO) 80301, USA

     VMF Others AUDIT
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    Excipients

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    Inspections and registrations

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    FDA

    read-more
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    01

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2016-07-14

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2016-07-14

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    02

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2015-05-27

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : Official Action Indicated

    Inspection End Date : 2015-05-27

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    03

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2015-05-27

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Official Action Indicated

    Inspection End Date : 2015-05-27

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    04

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-28

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-28

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    05

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-28

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-28

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    06

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2013-02-07

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : Official Action Indicated

    Inspection End Date : 2013-02-07

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    07

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2013-02-07

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Official Action Indicated

    Inspection End Date : 2013-02-07

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    08

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-13

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-13

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    09

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-13

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-07-13

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    10

    FDA Audited

    USA
    AusBiotech 2024
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    AusBiotech 2024
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-20

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2009-07-20

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    ABOUT THIS PAGE

    Contact Pfizer Inc and get a quotation

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    Find a price of Betamethyl Epoxide bulk with DMF, JDMF offered by Pfizer Inc

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