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List of Korea Drug Master Files (KDMF) for Amlodipine Besylate Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Pharmapia Co., Ltd.
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Chong Kun Dang Co., Ltd.
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2017-04-17
20120120-130-H-183-36(5)
Hetero Drugs Limited
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2014-03-06
20120120-130-H-183-36(1)
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2019-10-17
20120120-130-H-183-36(6)
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2016-04-19
20120120-130-H-183-36(4)
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Hanmi Pharmaceutical Co., Ltd.
2016-02-25
20120120-130-H-183-36(3)
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Celltrion Pharmaceutical Co., Ltd.
2015-04-15
20120120-130-H-183-36(2)
Hetero Drugs Limited.
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Novartis Korea Co., Ltd.
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Foosung Bio Co., Ltd.
2023-09-08
20120120-130-H-183-36(8)
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Korea Biochem Pharmaceutical Co., Ltd.
2014-07-21
20140721-130-H-264-44
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    Unichem Laboratories Ltd.
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    • TABLET;ORAL - EQ 10MG BASE
    • TABLET;ORAL - EQ 2.5MG BASE
    • TABLET;ORAL - EQ 5MG BASE
    • CAPSULE;ORAL - EQ 10MG BASE;20MG
    • CAPSULE;ORAL - EQ 10MG BASE;40MG
    • CAPSULE;ORAL - EQ 2.5MG BASE;10MG
    • CAPSULE;ORAL - EQ 5MG BASE;10MG
    • CAPSULE;ORAL - EQ 5MG BASE;20MG
    • CAPSULE;ORAL - EQ 5MG BASE;40MG
    • TABLET;ORAL - EQ 10MG BASE;14MG
    • TABLET;ORAL - EQ 2.5MG BASE;3.5MG
    • TABLET;ORAL - EQ 5MG BASE;7MG
    • TABLET;ORAL - EQ 10MG BASE;200MG
    • TABLET;ORAL - EQ 2.5MG BASE;200MG
    • TABLET;ORAL - EQ 5MG BASE;200MG
    • TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE
    • TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE
    • TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE
    • TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE
    • TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
    • TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE
    • TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
    • TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
    • TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE
    • TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE
    • TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE
    • TABLET;ORAL - EQ 10MG BASE;160MG
    • TABLET;ORAL - EQ 10MG BASE;320MG
    • TABLET;ORAL - EQ 5MG BASE;160MG
    • TABLET;ORAL - EQ 5MG BASE;320MG
    • TABLET;ORAL - EQ 10MG BASE;20MG
    • TABLET;ORAL - EQ 10MG BASE;40MG
    • TABLET;ORAL - EQ 5MG BASE;20MG
    • TABLET;ORAL - EQ 5MG BASE;40MG
    • TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG
    • TABLET;ORAL - EQ 10MG BASE;25MG;160MG
    • TABLET;ORAL - EQ 10MG BASE;25MG;320MG
    • TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG
    • TABLET;ORAL - EQ 5MG BASE;25MG;160MG
    • TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Looking for 111470-99-6 / Amlodipine Besylate API manufacturers, exporters & distributors?

    Amlodipine Besylate manufacturers, exporters & distributors 1

    73

    PharmaCompass offers a list of Amlodipine Besylate 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 Amlodipine Besylate manufacturer or Amlodipine Besylate supplier for your needs.

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

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

    API | Excipient name

    Amlodipine Besylate

    Synonyms

    111470-99-6, Amlodipine besilate, Amlodipine benzenesulfonate, Antacal, Monopina, Istin

    Cas Number

    111470-99-6

    Unique Ingredient Identifier (UNII)

    864V2Q084H

    About Amlodipine Besylate

    A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.

    Amlodipine Besylate Manufacturers

    A Amlodipine Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Besylate, including repackagers and relabelers. The FDA regulates Amlodipine Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine Besylate 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 Amlodipine Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Amlodipine Besylate Suppliers

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

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

    Amlodipine Besylate KDMF

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

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

    After submitting a Amlodipine Besylate 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 Amlodipine Besylate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Amlodipine Besylate suppliers with KDMF on PharmaCompass.

    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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