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Zhejiang Hengkang Amiodarone Hydrochloride Zhejiang Hengkang Amiodarone Hydrochloride

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List of Drug Master Files (DMF) of Amiodarone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 PMC Isochem (1)

02 Aurobindo Pharma Limited (1)

03 CTX Lifesciences (1)

04 Cambrex Corporation (1)

05 Emcure Pharmaceuticals (1)

06 Glenmark Life Sciences (1)

07 Hainan Poly Pharm (1)

08 Piramal Pharma Solutions (1)

09 Taro Pharmaceutical Industries (1)

10 Unichem Laboratories Limited (1)

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01 AMIODARONE HCL (1)

02 AMIODARONE HCL USP (1)

03 AMIODARONE HYDROCHLORIDE (3)

04 AMIODARONE HYDROCHLORIDE USP (5)

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01 China (1)

02 France (1)

03 India (5)

04 U.S.A (3)

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01 Active (9)

02 Inactive (1)

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01 Complete (6)

02 Blank (4)

URL Supplier Web Content
17217
Inactive
2004-03-05
N/A
II
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3505
Active
1979-04-11
Complete
2016-07-15
2016-06-17
II
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URL Supplier Web Content
25892
Active
2012-04-09
Complete
2016-05-24
2015-09-11
II
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URL Supplier Web Content
38160
Active
2023-05-11
N/A
II
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URL Supplier Web Content
16787
Active
2003-08-27
Complete
2019-03-28
2019-03-25
II
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URL Supplier Web Content
36163
Active
2021-09-07
Complete
2021-10-20
2021-09-07
II
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21694
Active
2008-06-12
Complete
2013-09-21
2013-09-10
II
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URL Supplier Web Content
NA Not Available For Sales
15794
Active
2001-12-27
N/A
II
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URL Supplier Web Content
33688
Active
2019-03-22
N/A
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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 USDMF

A Amiodarone DMF (Drug Master File) is a document detailing the whole manufacturing process of Amiodarone active pharmaceutical ingredient (API) in detail. Different forms of Amiodarone DMFs exist exist since differing nations have different regulations, such as Amiodarone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Amiodarone DMF submitted to regulatory agencies in the US is known as a USDMF. Amiodarone USDMF includes data on Amiodarone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amiodarone USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

Amiodarone Manufacturers | Traders | Suppliers

Amiodarone Manufacturers, Traders, Suppliers 1
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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