01 1Breathgreen Pharmaceuticals
02 2Cipla
01 2ENSIFENTRINE
02 1ENSIFENTRINE (C)
01 1China
02 2India
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41421
Submission : 2025-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42916
Submission : 2025-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41432
Submission : 2025-03-25
Status : Active
Type : II
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PharmaCompass offers a list of Ensifentrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ensifentrine manufacturer or Ensifentrine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ensifentrine manufacturer or Ensifentrine supplier.
A Ensifentrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensifentrine, including repackagers and relabelers. The FDA regulates Ensifentrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensifentrine 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 Ensifentrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ensifentrine supplier is an individual or a company that provides Ensifentrine active pharmaceutical ingredient (API) or Ensifentrine finished formulations upon request. The Ensifentrine suppliers may include Ensifentrine API manufacturers, exporters, distributors and traders.
click here to find a list of Ensifentrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ensifentrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ensifentrine active pharmaceutical ingredient (API) in detail. Different forms of Ensifentrine DMFs exist exist since differing nations have different regulations, such as Ensifentrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ensifentrine DMF submitted to regulatory agencies in the US is known as a USDMF. Ensifentrine USDMF includes data on Ensifentrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ensifentrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ensifentrine suppliers with USDMF on PharmaCompass.
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