PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
02 1Alivus Life Sciences
03 1Aurobindo Pharma Limited
04 1CTX Lifesciences
05 1Cambrex Corporation
06 1Emcure Pharmaceuticals
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
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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.
A Nexterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexterone, including repackagers and relabelers. The FDA regulates Nexterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexterone 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 Nexterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexterone supplier is an individual or a company that provides Nexterone active pharmaceutical ingredient (API) or Nexterone finished formulations upon request. The Nexterone suppliers may include Nexterone API manufacturers, exporters, distributors and traders.
click here to find a list of Nexterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexterone active pharmaceutical ingredient (API) in detail. Different forms of Nexterone DMFs exist exist since differing nations have different regulations, such as Nexterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexterone DMF submitted to regulatory agencies in the US is known as a USDMF. Nexterone USDMF includes data on Nexterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexterone suppliers with USDMF on PharmaCompass.
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