PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
02 1Aurobindo Pharma Limited
03 1CTX Lifesciences
04 1Cambrex Corporation
05 1Emcure Pharmaceuticals
06 1Glenmark Life Sciences
07 1Hainan Poly Pharm
08 1Piramal Pharma Solutions
09 1Taro Pharmaceutical Industries
10 1Unichem Laboratories Limited
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 7617
Submission : 1988-08-02
Status :
Type : II
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.
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.
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.
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