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Zhejiang Hengkang Amiodarone Hydrochloride Zhejiang Hengkang Amiodarone Hydrochloride

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

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01 Zhejiang Hengkang Pharmaceutical Co., Ltd. (1)

02 PMC ISOCHEM (1)

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01 Bahnsen Co., Ltd. (1)

02 Korea Chorus Co., Ltd. (1)

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01 Amiodarone hydrochloride (2)

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01 China (1)

02 France (1)

Bahnsen Co., Ltd.
2018-11-14
20181114-210-J-274
Zhejiang Hengkang Pharmac...
China
No.1 Longxiang Road, Hair...
Korea Chorus Co., Ltd.
2023-08-09
20230809-210-J-1536
PMC ISOCHEM
France
4 Avenue Philippe Lebon, ...

Looking for 19774-82-4 / Amiodarone API manufacturers, exporters & distributors?

Amiodarone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amiodarone

Synonyms

19774-82-4, Amiodarone hcl, Nexterone, Amiodar, Pacerone, Ritmocardyl

Cas Number

19774-82-4

Unique Ingredient Identifier (UNII)

976728SY6Z

About Amiodarone

An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.

Amiodarone Manufacturers

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

Amiodarone Suppliers

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

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

Amiodarone KDMF

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

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

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

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

Amiodarone Manufacturers | Traders | Suppliers

Amiodarone Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Amiodarone

Get in contact with the supplier of your choice:

  1. PMC Isochem
  2. Zhejiang Hengkang Pharmaceutical
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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