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01 1Breathgreen Pharmaceuticals
02 1Cipla
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01 2ENSIFENTRINE
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01 1India
02 1U.S.A
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01 2Active
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01 2Blank
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 : 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, Price,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.
PharmaCompass also assists you with knowing the Ensifentrine API Price utilized in the formulation of products. Ensifentrine API Price is not always fixed or binding as the Ensifentrine Price is obtained through a variety of data sources. The Ensifentrine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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, COA and API Price 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, COA and API Price 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.
We have 2 companies offering Ensifentrine
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