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    About

    We create chemistry for a sustainable future. In line with our corporate purpose, around 112,000 employees contribute to the success of our customers in nearly all sectors and almost every country in the world. Our broad portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. In 2015, BASF posted sales of €70 billion and income from operations before special items of app...
    We create chemistry for a sustainable future. In line with our corporate purpose, around 112,000 employees contribute to the success of our customers in nearly all sectors and almost every country in the world. Our broad portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. In 2015, BASF posted sales of €70 billion and income from operations before special items of approximately €6.7 billion. We combine economic success with environmental protection and social responsibility. Through research and innovation, we support our customers in nearly every industry.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4867

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

    The year 2024 was marked by some landmark drug approvals in the areas of schizophrenia, metabolic dysfunction-associated steatohepatitis (MASH), chronic obstructive pulmonary disease (COPD) and Alzheimer’s disease. The incoming Trump administration, monkeypox outbreak and drug price negotiations in the US also created big news. Here is PharmaCompass’ compilation of the top 10 news from Phispers of 2024. I. BMS’ US$ 14 bn Karuna bet pays off with landmark FDA approval for schizophrenia med Cobenfy The US Food and Drug Administration’s groundbreaking approval of Bristol Myers Squibb’s Cobenfy to treat schizophrenia has made it to our number one spot. BMS had acquired Cobenfy through its US$ 14 billion purchase of Karuna Therapeutics, announced in December 2023. Cobenfy is the first-ever antipsychotic that targets cholinergic receptors. Cobenfy’s new approach has experts excited. Its peak sales are expected to come in at US$ 7.5 billion a year. While BMS’ Karuna buyout paid off, AbbVie’s US$ 8.7 billion acquisition of Cerevel Therapeutics was dampened when their lead candidate and schizophrenia drug emraclidine failed to meet phase 2 endpoints in two pivotal trials. II. 2024’s biggest deal, US$ 16.5 bn Catalent buyout by Novo’s parent, cleared after intense scrutiny  On number two spot is Novo Nordisk Foundation’s acquistion of Catalent via its investment arm Novo Holdings for US$ 16.5 billion, announced in February 2024. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Easily the biggest biopharma acquisition of last year, the deal  faced criticism from lawmakers and consumer groups for its potential anti-competitive effects, particularly in the glucagon-like peptide-1 (GLP-1) drug market. Its main competitor Eli Lilly called for scrutiny by competition regulators. However, in December, both the EU regulator and the US Federal Trade Commission gave it the greenlight. III. Madrigal’s Rezdiffra becomes first FDA-approved drug for liver disease MASH For quite some time, the drug development field for the liver condition MASH had been a graveyard for failed programs. In 2024, the field celebrated a hurrah moment when Madrigal’s oral drug Rezdiffra became the first treatment in the US for adults with this common fatty liver disease. The approval has opened a multi-billion dollar opportunity for Madrigal with the American Liver Foundation CEO Lorraine Stiehl calling it a “game-changing” moment. IV. COPD patients get two new treatments — Verona’s Ohtuvayre and Sanofi-Regeneron’s Dupixent The COPD landscape saw remarkable advances in 2024. FDA approved Verona Pharma’s Ohtuvayre, which brings the first new mechanism of action in over two decades for the treatment of COPD. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management. Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Over 390 million people are living with COPD worldwide. V. Novartis inks 20 deals in 2024, promises over US$ 25 billion in biobucks, lays bets on radiopharmas Novartis has been investing in early-stage science, buying out companies in the sub-US$ 5 billion range. The Swiss drugmaker Novartis inked over 20 deals in 2024, paying over US$ 5.5 billion upfront and promising over US$ 25 billion in biobucks. The company has particularly focused on radiopharmaceuticals and molecular glue degraders. It acquired Mariana Oncology to strengthen its radioligand therapy (RLT) pipeline, and also inked RLT deals with PeptiDream and Ratio Therapeutics. VI. Despite political pressure, FDA rejects first MDMA-assisted therapy to treat PTSD; Lykos faces expanded probe In August, FDA declined to approve an MDMA-assisted therapy from Lykos Therapeutics to treat post-traumatic stress disorder (PTSD). In the lead-up to the FDA decision, 80 members of Congress from both sides of the aisle had urged US President Joe Biden and the FDA to consider further studies on the therapy. Not satisfied with just declining Lykos’ MDMA-assisted therapy for PTSD, FDA had expanded its investigation into the clinical trials that tested it. Lykos CEO Amy Emerson stepped down after reducing its workforce by 75 percent. Additionally, its founder Rick Doblin exited its board. VII. Alzheimer’s gets two new treatments as FDA approves Lilly’s Kisunla, Alpha Cognition’s Zunveyl FDA finally approved Eli Lilly’s Alzheimer’s drug Kisunla in July, after delaying action on it in March. This approval, along with that of Biogen and Eisai’s Leqembi in 2023, mark successes in treating the mind-wasting disease after three decades of failed efforts. FDA also approved Alpha Cognition’s Zunveyl to treat mild-to-moderate Alzheimer’s disease. Zunveyl is a prodrug of Alzheimer’s medication galantamine, and is to be taken orally twice a day. Alpha said Zunveyl is designed to address the tolerability issues with galantamine. VIII. IRA price talks conclude; Stelara, Enbrel, Eliquis to bring 51.4% of Medicare savings After filing futile lawsuits questioning the constitutional validity of the Medicare drug price negotiations under the Inflation Reduction Act (IRA), all drug companies came to the bargaining table. In August, the Biden-Harris Administration announced it had reached agreements for lower prices for all 10 drugs selected for negotiations under the IRA. The new prices come into effect from January 1, 2026. A Brookings Institution report said that just three drugs will account for over half of the expected US$ 6 billion savings in 2026. J&J’s Stelara (US$ 1.4 billion), Amgen’s Enbrel (US$ 1.1 billion), and BMS’ Eliquis (US$ 856 million) are expected to account for US$ 3.28 billion or 51.4 percent of Medicare savings. IX. Trump’s picks for new administration send shockwaves across markets, stocks of vaccine makers tumble  Donald Trump’s picks for his new administration not only created big news, but also impacted the stock markets. His selection of Robert F. Kennedy Jr., an anti-vaccine activist, to lead the Department of Health and Human Services (HHS), sent shares of several vaccine manufacturers plummeting. In the US, stocks of Pfizer, Moderna, and Novavax dipped. In Europe, stocks of BioNTech, GSK, and Bavarian Nordic tumbled. Trump has nominated Mehmet Oz, a celebrity TV host, to run the Centers for Medicare and Medicaid Services (CMS), which oversees health insurance. X. New mpox outbreak in Africa sparks global response; FDA approves Emergent’s vaccine to treat mpox In August, a new mpox virus clade put Africa in the throes of an mpox outbreak. The WHO declared it a public health emergency of international concern. Emergent BioSolutions said it will donate 50,000 doses of its smallpox vaccine ACAM2000. Multiple countries responded with donations of Bavarian Nordic’s Jynneos, the only widely-approved mpox vaccine at the time. In early September, the FDA approved Emergent’s ACAM2000 as the second mpox vaccine.
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    Impressions: 1919

    https://www.pharmacompass.com/radio-compass-blog/fda-s-landmark-approvals-of-bms-schizo-med-madrigal-s-mash-drug-us-16-5-bn-catalent-buyout-make-it-to-top-10-news-of-2024

    #Phispers by PHARMACOMPASS
    02 Jan 2025
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    NEWS #PharmaBuzz

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    BASF Sells Food & Health Performance Ingredients to Louis Dreyfus
    BASF Sells Food & Health Performance Ingredients to Louis Dreyfus

    24 Dec 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/basf-sells-food-and-health-performance-ingredients-business-to-louis-dreyfus-company-16572

    INDPHARMAPOST
    24 Dec 2024
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    BASF Introduces Pepsensyal Peptide For Slow-Aging Skin Care
    BASF Introduces Pepsensyal Peptide For Slow-Aging Skin Care

    23 Oct 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/basf-introduces-pepsensyal-peptide-for-slow-aging-skin-care-solutions/

    EXPRESSPHARMA
    23 Oct 2024
    Share Share
    BASF to prepare agricultural business for IPO, Bloomberg reports
    BASF to prepare agricultural business for IPO, Bloomberg reports

    18 Sep 2024

    // REUTERS

    https://www.reuters.com/markets/europe/basf-expected-announce-listing-plans-agri-chemicals-division-reports-bloomberg-2024-09-18/

    REUTERS
    18 Sep 2024
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    German chemical sector employers, union agree 6.85% pay hike over 20 months
    German chemical sector employers, union agree 6.85% pay hike over 20 months

    27 Jun 2024

    // REUTERS

    https://www.reuters.com/markets/commodities/german-chemical-sector-employers-union-agree-685-pay-hike-over-20-months-2024-06-27/

    REUTERS
    27 Jun 2024
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    Signet, BASF organize Formulator’s Forum: Exchange Excipients Innovation in Hyd
    Signet, BASF organize Formulator’s Forum: Exchange Excipients Innovation in Hyd

    08 Apr 2024

    // PHARMABIZ

    https://www.pharmabiz.com/NewsDetails.aspx?aid=168392&sid=2

    PHARMABIZ
    08 Apr 2024
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    Launch of cooperation with BASF Pharma Solutions ZoomLab™
    Launch of cooperation with BASF Pharma Solutions ZoomLab™

    02 Feb 2023

    // PRESS RELEASE

    https://www.midas-pharma.com/en/latest-activities/cooperation-with-basf-zoomlab/

    PRESS RELEASE
    02 Feb 2023
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    ALL APIs

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    01

    Ibuprofen

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Ibuprofen

    Germany

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • EDQM
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-05

    Pay. Date : 2013-01-24

    DMF Number : 8709

    Submission : 1990-09-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-087 - Rev 03

    Issue Date : 2018-12-07

    Type : Chemical

    Substance Number : 721

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10984

    Registrant's Address : 100 Park Avenue, Florham Park, New Jersey, 07932, United States of America

    Initial Date of Registration : 2005-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 10117-0926

    Start Marketing Date : 2010-06-08

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Parmarine Co., Ltd.

    Registration Date : 2024-12-23

    Registration Number : 20220725-209-J-1335(1)

    Manufacturer Name : BASF Corporation

    Manufacturer Address : Highway 77 South, Bishop, Texas 78343 (5738 County Road 4, Bishop, Texas 78343), USA

     VMF Others AUDIT
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    02

    Povidone-Iodine

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Povidone-Iodine

    Germany

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3017

    Submission : 1977-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-179 - Rev 00

    Issue Date : 2015-10-21

    Type : Chemical

    Substance Number : 1142

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10985

    Registrant's Address : 100 Park Avenue, Florham Park, New Jersey, 07932, United States of America

    Initial Date of Registration : 2005-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 70177-0002

    Start Marketing Date : 2010-01-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Riboflavin

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Riboflavin

    Germany

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4407

    Submission : 1981-11-25

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-069 - Rev 00

    Issue Date : 2017-11-07

    Type : Chemical

    Substance Number : 292

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10235

    Registrant's Address : 14-16F KCCI Bldg. , 39, Sejongdaero, Jung-gu, Seoul, Republic of Korea

    Initial Date of Registration : 2016-12-26

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Icosapent Ethyl

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Icosapent Ethyl

    Germany

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-02

    Pay. Date : 2020-10-20

    DMF Number : 23911

    Submission : 2010-07-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 223MF10118

    Registrant's Address : 4th and 5th Floors, 2 Stockport Exchange, Railway Road, Stockport, SK1 3GG, UK

    Initial Date of Registration : 2011-07-25

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    05

    Levomenthol

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Levomenthol

    Germany

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-08-26

    Pay. Date : 2020-06-08

    DMF Number : 26711

    Submission : 2012-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-390 - Rev 01

    Issue Date : 2021-06-16

    Type : Chemical

    Substance Number : 619

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48041-0001

    Start Marketing Date : 2014-07-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Omega-3-Acid Ethyl Esters 90

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Omega-3-Acid Ethyl Esters 90

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-298 - Rev 04

    Issue Date : 2024-08-21

    Type : Chemical

    Substance Number : 1352

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10051

    Registrant's Address : Lilleakerveien 2B, NO-0283 Oslo, Norway P. O. Box 420, NO-1327 Lysaker, Norway

    Initial Date of Registration : 2011-04-12

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : BASF Korea Ltd.

    Registration Date : 2012-12-27

    Registration Number : No. 6246-1-ND

    Manufacturer Name : BASF Pharma (Callanish) Ltd

    Manufacturer Address : Breasclete, Callanish, Isle of Lewis, HS2 9ED, Scotland

     VMF Others AUDIT
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    07

    Vitamin E

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Vitamin E

    Germany

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5826

    Submission : 1985-05-06

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-039 - Rev 02

    Issue Date : 2023-06-30

    Type : Chemical

    Substance Number : 692

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    08

    Vitamin E Acetate

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Vitamin E Acetate

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5818

    Submission : 1985-05-06

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10983

    Registrant's Address : Carl-Bosch-Strasse 38,67056 Ludwigshafen, Federal Republic of Germany

    Initial Date of Registration : 2005-11-21

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Market
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    09

    Azelaic Acid

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Azelaic Acid

    Germany

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11615

    Submission : 1995-08-04

    Status : Active

    Type : II

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

    NDC Package Code : 48041-4700

    Start Marketing Date : 2013-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    10

    Octocrylene

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Octocrylene

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12600

    Submission : 1997-07-17

    Status : Active

    Type : II

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

    read-more
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    01

    5-ethenyl-pyrrolidin-2-one

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    02

    7,-8-didehydro-retinoic Acid

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    9-z-isotretinoin

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Acetaminophen

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Acetohexamide

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Acitretin

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Allopurinol

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Amsacrine

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Ascorbic Acid

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Beta-carotene (25mg.) Soft Gelatin C...

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    CEP/COS

    read-more
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    01

    Acitretin

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Acitretin

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    BASF

    Certificate Numbers : R1-CEP 2007-201 - Rev 00

    Status : Withdrawn by Holder

    Issue Date : 2013-11-15

    Type : Chemical

    Substance Number : 1385

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    02

    all-rac-alpha-Tocopherol

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    all-rac-alpha-Tocopheryl acetate

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Ascorbic acid

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Ascorbic acid

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    BASF

    Certificate Numbers : R2-CEP 1994-001 - Rev 01

    Status : Withdrawn by EDQM F...

    Issue Date : 2006-05-13

    Type : Chemical

    Substance Number : 253

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    Market
    Place

    05

    Ascorbic acid

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    Calcium ascorbate dihydrate

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    Calcium Pantothenate

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Copovidone, Nominal K-value 28

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Dexpanthenol

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Ibuprofen

    CEP/COS

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    FDA Orange Book

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    Europe

    read-more
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    01

    Brand Name : Omacor

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Brand Name : Omacor

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Omega-3 acid ethyl esters 90

    BASF

    Dosage Form : Kapsel, myk

    Dosage Strength : 1000 mg

    Packaging : Boks av plast 9...

    Brand Name : Omacor

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Excipients

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    All Excipients

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    01

    Crospovidone

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

    Duphat
    Not Confirmed
    arrow

    Crospovidone

    Germany

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

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    Duphat
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2855

    Submission : 1977-02-08

    Status : Active

    Type : IV

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-076 - Rev 01

    Issue Date : 2015-06-26

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Povidone

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

    Duphat
    Not Confirmed
    arrow

    Povidone

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32695

    Submission : 2018-03-27

    Status : Active

    Type : IV

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-077 - Rev 02

    Issue Date : 2017-01-30

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    Povidone API

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

    Duphat
    Not Confirmed
    arrow

    Povidone API

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22604

    Submission : 2009-01-19

    Status : Active

    Type : IV

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-106 - Rev 03

    Issue Date : 2020-09-08

    Type :

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Cocoyl Caprylocaprate

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

    Duphat
    Not Confirmed
    arrow

    Cocoyl Caprylocaprate

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16496

    Submission : 2003-03-25

    Status : Active

    Type : IV

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

    05

    Isopropyl Myristate

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

    Duphat
    Not Confirmed
    arrow

    Isopropyl Myristate

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16498

    Submission : 2003-03-25

    Status : Active

    Type : IV

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

    06

    Medium Chain Triglycerides Excipien...

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

    Duphat
    Not Confirmed
    arrow

    Medium Chain Triglycerides Excipien...

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16495

    Submission : 2003-03-25

    Status : Active

    Type : IV

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

    07

    Methacrylic Acid - Ethyl Acrylate C...

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

    Duphat
    Not Confirmed
    arrow

    Methacrylic Acid - Ethyl Acrylate C...

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14823

    Submission : 2000-04-11

    Status : Active

    Type : IV

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

    08

    Octyldodecanol

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

    Duphat
    Not Confirmed
    arrow

    Octyldodecanol

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16494

    Submission : 2003-03-25

    Status : Active

    Type : IV

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

    09

    Oleyl Alcohol

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

    Duphat
    Not Confirmed
    arrow

    Oleyl Alcohol

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16497

    Submission : 2003-03-25

    Status : Active

    Type : IV

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

    10

    Polyvinyl Acetate

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

    Duphat
    Not Confirmed
    arrow

    Polyvinyl Acetate

    Germany

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

    arrow
    Duphat
    Not Confirmed
    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15055

    Submission : 2000-09-20

    Status : Active

    Type : IV

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

    read-more
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    01

    Crospovidone, Type A and B

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Crospovidone, Type A and B

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    BASF

    Certificate Numbers : R1-CEP 2007-076 - Rev 01

    Status : Valid

    Issue Date : 2015-06-26

    Type : Chemical

    Substance Number : 892

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    Excipients Web Link

    Market Place

    02

    Macrogol 15 hydroxystearate

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Macrogol 15 hydroxystearate

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    BASF

    Certificate Numbers : R1-CEP 2006-095 - Rev 01

    Status : Valid

    Issue Date : 2018-06-08

    Type : Chemical

    Substance Number : 2052

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    Market Place

    03

    Povidone, 'Nominal K-value 12' and 'nomi...

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Povidone, 'Nominal K-value 25' and 'nomi...

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Povidone, 'Nominal K-value 90'

    Germany
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Povidone, 'Nominal K-value 90'

    Germany
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
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    BASF

    Certificate Numbers : R1-CEP 2007-078 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2017-01-30

    Type : Chemical

    Substance Number : 685

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    Stearic Acid

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    01

    Brand Name : Kolliwax S

    Germany

    arrow
    Biotech Showcase
    Not Confirmed

    02

    Brand Name : Kolliwax S Fine

    Germany

    arrow
    Biotech Showcase
    Not Confirmed
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    Excipients By applications

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    Thickeners and Stabilizers

    read-more
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    01

    Brand Name : Kolliphor P188

    Germany

    arrow
    Duphat
    Not Confirmed

    02

    Brand Name : Kolliphor P338

    Germany

    arrow
    Duphat
    Not Confirmed

    03

    Brand Name : Kolliphor P407

    Germany

    arrow
    Duphat
    Not Confirmed

    04

    Brand Name : Kollisolv PEG 1000

    Germany

    arrow
    Duphat
    Not Confirmed

    05

    Brand Name : Kollisolv PEG 1450

    Germany

    arrow
    Duphat
    Not Confirmed

    06

    Brand Name : Kollisolv PEG 3350

    Germany

    arrow
    Duphat
    Not Confirmed

    07

    Brand Name : Kollisolv PEG 8000

    Germany

    arrow
    Duphat
    Not Confirmed

    08

    Brand Name : Kolliwax CA

    Germany

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    Duphat
    Not Confirmed

    09

    Brand Name : Kolliwax CSA 50

    Germany

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    Brand Name : Kolliwax CSA 70

    Germany

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    Brand Name : Kollicoat MAE 30 DP

    Germany

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    Brand Name : Kollicoat Smartseal 30 D

    Germany

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    Brand Name : Kollicoat SR 30 D

    Germany

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