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    List of Drug Master Files (KDMF) for Rosuvastatin Calcium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Rosuvastatin Calcium

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    01 Centrient Pharmaceuticals India Private Limited (2)

    02 Ajinomoto Omnichem N.V. (1)

    03 Amoli Organics Private Limited (1)

    04 Asia Chemical Industries Ltd. Teva-Tech site (1)

    05 Biocon Limited (18)

    06 CTX Life Sciences Pvt. Ltd (1)

    07 CTX Life Sciences Pvt. Ltd. (2)

    08 Cadchem Laboratories Limited (1)

    09 ENGCHEM Life Science Co., Ltd. (1)

    10 HLGnomics Co., Ltd. (1)

    11 Hanmi Fine Chemical Co., Ltd. (1)

    12 Ildong Pharmaceutical Co., Ltd. (1)

    13 Inist ST Co., Ltd. (1)

    14 Jeil Pharmaceutical Co., Ltd. @MFC Co., Ltd. (1)

    15 Korea Biochem Pharmaceutical Co., Ltd. (1)

    16 Kyungbo Pharmaceutical Co., Ltd. (1)

    17 Lee Pharma Limited (1)

    18 Lek Pharmaceuticals d.d. (1)

    19 Lonza AG (1)

    20 Lupine Limited (1)

    21 MFC Co., Ltd. (1)

    22 MSN Laboratories Private Limited (17)

    23 Melody Healthcare PVT. LTD (1)

    24 Melody Healthcare Pvt. Ltd (9)

    25 Nantong Chanyoo Pharmatech Co., Ltd. Ltd (2)

    26 PT Kimia Farma Sungwun Pharmacopia@Zhejiang LEPU Pharmaceutical Co., Ltd. (1)

    27 Redox Bio Co., Ltd. (1)

    28 Ruyuan HEC Pharm Co., Ltd. (2)

    29 Ruyuan Hec Pharma Co., Ltd (1)

    30 Ruyuan Hec Pharma Co.,Ltd. (2)

    31 ST Pharm Co., Ltd. (1)

    32 Samjin Pharmaceutical Co., Ltd. (2)

    33 Shaoxing Jingxin Pharmaceutical Co., Ltd. (2)

    34 Teva API India Private Limited (1)

    35 Yuhan Chemical Co., Ltd. (1)

    36 Zhejiang Jiangbei Pharmaceutical Co., Ltd. (2)

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    01 Ace Biopharm Co., Ltd. (1)

    02 Aging Life Science Co., Ltd. (1)

    03 Alvogen Korea Co., Ltd. (1)

    04 Anguk Pharmaceutical Co., Ltd. (2)

    05 AstraZeneca Korea Co., Ltd. (2)

    06 Bahnsen Co., Ltd. (2)

    07 Boryeong Co., Ltd. (1)

    08 Bukwang Pharmaceutical Co., Ltd. (1)

    09 CMG Pharmaceutical Co., Ltd. (2)

    10 Classia Co., Ltd. (1)

    11 Daebong LS Co., Ltd. (2)

    12 Daesin Pharmaceutical Co., Ltd. (1)

    13 Daewon Pharmaceutical Co., Ltd. (1)

    14 Daewoong Pharmaceutical Co., Ltd. (1)

    15 ENGCHEM Life Science Co., Ltd. (1)

    16 Ellison Pharmaceutical Co., Ltd. (1)

    17 Farmirae Co., Ltd. (1)

    18 Grace Farm (1)

    19 HLGnomics Co., Ltd. (1)

    20 Hanmi Fine Chemical Co., Ltd. (1)

    21 Hanmi Pharmaceutical Co., Ltd. (1)

    22 Hanyoung Farm Co., Ltd. (3)

    23 Huseed Co., Ltd. (2)

    24 Hwail Pharmaceutical Co., Ltd. (3)

    25 IMCD Korea Co., Ltd. (2)

    26 Ildong Pharmaceutical Co., Ltd. (1)

    27 Inist ST Co., Ltd. (1)

    28 JSP Co., Ltd. (1)

    29 Jeil Pharmaceutical Co., Ltd. (1)

    30 KR Farm Co., Ltd. (2)

    31 Kookjeon Pharmaceutical Co., Ltd. (2)

    32 Korea Biochem Pharmaceutical Co., Ltd. (1)

    33 Kyungbo Pharmaceutical Co., Ltd. (1)

    34 Kyungdong Pharmaceutical Co., Ltd. (1)

    35 Leesung International Co., Ltd. (2)

    36 MFC Co., Ltd. (1)

    37 Masung LS Co., Ltd. (1)

    38 Mpeak Korea Co., Ltd. (2)

    39 Myungmoon Pharmaceutical Co., Ltd. (1)

    40 Nensis Co., Ltd. (1)

    41 Otran Farm Korea Co., Ltd. (1)

    42 Pampia Co., Ltd. (1)

    43 Pharma Science Korea Co., Ltd. (1)

    44 Pharma Solution Co., Ltd. (1)

    45 Pharmapia Co., Ltd. (3)

    46 QI Trading Co., Ltd. (1)

    47 Redox Bio Co., Ltd. (1)

    48 SG Biochem Co., Ltd. (3)

    49 ST Pharm Co., Ltd. (1)

    50 Samil Pharmaceutical Co., Ltd. (1)

    51 Samjin Pharmaceutical Co., Ltd. (2)

    52 Samo Pharmaceutical Co., Ltd. (2)

    53 Sampoong Pharmachem Co., Ltd. (1)

    54 Sandoz Korea Co., Ltd. (1)

    55 Sangjin Trading Co., Ltd. (1)

    56 Seongui Bio Co., Ltd. (1)

    57 Seongwoon Pharmacopia Co., Ltd. (1)

    58 Sungjin Exim Co., Ltd. (2)

    59 Toru Co., Ltd. (3)

    60 Youngjin Pharmaceutical Co., Ltd. (1)

    61 Yuhan Chemical Co., Ltd. (1)

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    01 Rosuvastatin Calcium (78)

    02 Rosuvastatin calcium (micronized) (7)

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    01 China (11)

    02 India (52)

    03 Indonesia (1)

    04 Israel (2)

    05 Japan (1)

    06 Netherlands (2)

    07 Slovenia (1)

    08 South Korea (13)

    09 U.S.A (1)

    10 Blank (1)

    ListList of Suppliers
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    Centrient Pharmaceuticals

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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    Rosuvastatin Calcium

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    URL Supplier Web Content
    Daesin Pharmaceutical Co., Ltd.
    2020-12-17
    20200707-209-J-677(1)
    Centrient Pharmaceuticals...
    India
    Bhai Mohan Singh Nagar, T...
    Centrient Pharmaceuticals

    Iran Expo

    Not Confirmed

    envelop Contact Supplier

    Centrient Pharmaceuticals

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
    Contact Supplier Contact Supplier
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rosuvastatin Calcium

    PDF Supplier PDF
    URL Supplier Web Content
    Aging Life Science Co., Ltd.
    2020-07-07
    20200707-209-J-677
    Centrient Pharmaceuticals...
    India
    Bhai Mohan Singh Nagar, T...
    Centrient Pharmaceuticals

    Iran Expo

    Not Confirmed

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    Biocon

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    • FDA
    • EDQM
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
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    Flag India
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    Rosuvastatin Calcium

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    Ace Biopharm Co., Ltd.
    2023-11-22
    20200107-209-J-320(7)
    Biocon Limited
    India
    Plot No. 213 -215 and 216...
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    Cadchem Laboratories

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      Rosuvastatin Calcium

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      Pampia Co., Ltd.
      2023-04-07
      20230407-209-J-1470
      Cadchem Laboratories Limi...
      India
      Village Jaula Khurd, Tehs...
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      CTX Lifesciences

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      Rosuvastatin Calcium

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      Pharmapia Co., Ltd.
      2023-12-11
      20190115-209-J-121(2)
      CTX Life Sciences Pvt. Lt...
      India
      Block No. 251/P, 252/P, 2...
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      HEC Pharm

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      Rosuvastatin Calcium

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      KR Farm Co., Ltd.
      2023-07-11
      20191219-209-J-510(4)
      Ruyuan HEC Pharm Co., Ltd...
      China
      Xiaba Development Zone, R...
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      Melody Healthcare Pvt Ltd

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      • EDQM
      • WHO-GMP
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      Rosuvastatin calcium (micronized)

      PDF Supplier PDF
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      Huseed Co., Ltd.
      2023-02-22
      20210721-209-J-1074(3)
      Melody Healthcare Pvt. Lt...
      India
      Plot No. J-73, MIDC, Tara...
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      MSN Laboratories

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      Rosuvastatin Calcium

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      JSP Co., Ltd.
      2023-03-23
      20190220-209-J-215(13)
      MSN Laboratories Private ...
      India
      Sy. No. 317, 320, 321, 32...
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      PT Kimia Farma Sungwun Pharmacopia

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        Rosuvastatin Calcium

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        Seongwoon Pharmacopia Co., Ltd.
        2023-03-23
        20230323-209-J-1463
        PT Kimia Farma Sungwun Ph...
        Indonesia
        Delta Silicon 1 – Kawas...
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        Zhejiang Jingxin Pharmaceutical Co....

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        • EDQM
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        Flag China
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        Rosuvastatin Calcium

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        KR Farm Co., Ltd.
        2023-05-17
        20221130-209-J-1235(1)
        Shaoxing Jingxin Pharmace...
        China
        No.31, Weisan Road, Hangz...
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        Looking for 147098-20-2 / Rosuvastatin Calcium API manufacturers, exporters & distributors?

        Rosuvastatin Calcium manufacturers, exporters & distributors 1

        11

        PharmaCompass offers a list of Rosuvastatin Calcium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier for your needs.

        Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rosuvastatin Calcium manufacturer or Rosuvastatin Calcium supplier.

        PharmaCompass also assists you with knowing the Rosuvastatin Calcium API Price utilized in the formulation of products. Rosuvastatin Calcium API Price is not always fixed or binding as the Rosuvastatin Calcium Price is obtained through a variety of data sources. The Rosuvastatin Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

        API | Excipient name

        Rosuvastatin Calcium

        Synonyms

        147098-20-2, Crestor, Rosuvastatin hemicalcium, Fortius, Rostar, Rosuvastatin calcium salt

        Cas Number

        147098-20-2

        Unique Ingredient Identifier (UNII)

        83MVU38M7Q

        About Rosuvastatin Calcium

        A HYDROXYMETHYLGLUTARYL-COA-REDUCTASE INHIBITOR, or statin, that reduces the plasma concentrations of LDL-CHOLESTEROL; APOLIPOPROTEIN B, and TRIGLYCERIDES while increasing HDL-CHOLESTEROL levels in patients with HYPERCHOLESTEROLEMIA and those at risk for CARDIOVASCULAR DISEASES.

        Rosuvastatin Calcium Manufacturers

        A Rosuvastatin Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosuvastatin Calcium, including repackagers and relabelers. The FDA regulates Rosuvastatin Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosuvastatin Calcium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

        click here to find a list of Rosuvastatin Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

        Rosuvastatin Calcium Suppliers

        A Rosuvastatin Calcium supplier is an individual or a company that provides Rosuvastatin Calcium active pharmaceutical ingredient (API) or Rosuvastatin Calcium finished formulations upon request. The Rosuvastatin Calcium suppliers may include Rosuvastatin Calcium API manufacturers, exporters, distributors and traders.

        click here to find a list of Rosuvastatin Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

        Rosuvastatin Calcium KDMF

        In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

        Pharmaceutical companies submit a Rosuvastatin Calcium Drug Master File in Korea (Rosuvastatin Calcium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rosuvastatin Calcium. The MFDS reviews the Rosuvastatin Calcium KDMF as part of the drug registration process and uses the information provided in the Rosuvastatin Calcium KDMF to evaluate the safety and efficacy of the drug.

        After submitting a Rosuvastatin Calcium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Rosuvastatin Calcium API can apply through the Korea Drug Master File (KDMF).

        click here to find a list of Rosuvastatin Calcium suppliers with KDMF on PharmaCompass.

        Rosuvastatin Calcium Manufacturers | Traders | Suppliers

        Rosuvastatin Calcium Manufacturers, Traders, Suppliers 1
        90

        We have 31 companies offering Rosuvastatin Calcium

        Get in contact with the supplier of your choice:

        1. Centrient Pharmaceuticals
        2. Ajinomoto Company
        3. Amoli Organics
        4. Assia Chemical Industries Ltd
        5. Biocon
        6. Cadchem Laboratories
        7. CTX Lifesciences
        8. Hanmi Pharmaceutical
        9. HEC Pharm
        10. HL Genomics
        11. Ildong Pharmaceutical
        12. Inist
        13. Jeil Pharmaceutical Co., Ltd
        14. Korea Biochem Pharm
        15. Kyongbo Pharmaceutical Co., Ltd
        16. Lee Pharma
        17. Lek Pharmaceuticals
        18. Lonza Inc & Lonza America Inc
        19. Lupin Ltd
        20. Melody Healthcare Pvt Ltd
        21. MFC
        22. MSN Laboratories
        23. Nantong Chanyoo Pharmatech
        24. PT Kimia Farma Sungwun Pharmacopia
        25. Redox Bio
        26. Samjin pharm Co. Ltd
        27. ST Pharma
        28. Teva API
        29. Yuhan Corporation
        30. Zhejiang Jiangbei Pharmaceutical Co., Ltd.
        31. Zhejiang Jingxin Pharmaceutical Co. ltd
        Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
        For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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