01 1MSN Laboratories
02 1Viatris
01 2BEDAQUILINE FUMARATE
01 1India
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33268
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35426
Submission : 2020-12-14
Status : Active
Type : II
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PharmaCompass offers a list of Bedaquiline 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 Bedaquiline manufacturer or Bedaquiline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bedaquiline manufacturer or Bedaquiline supplier.
PharmaCompass also assists you with knowing the Bedaquiline API Price utilized in the formulation of products. Bedaquiline API Price is not always fixed or binding as the Bedaquiline Price is obtained through a variety of data sources. The Bedaquiline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bedaquiline (fumarate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bedaquiline (fumarate), including repackagers and relabelers. The FDA regulates Bedaquiline (fumarate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bedaquiline (fumarate) 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 Bedaquiline (fumarate) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bedaquiline (fumarate) supplier is an individual or a company that provides Bedaquiline (fumarate) active pharmaceutical ingredient (API) or Bedaquiline (fumarate) finished formulations upon request. The Bedaquiline (fumarate) suppliers may include Bedaquiline (fumarate) API manufacturers, exporters, distributors and traders.
click here to find a list of Bedaquiline (fumarate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bedaquiline (fumarate) DMF (Drug Master File) is a document detailing the whole manufacturing process of Bedaquiline (fumarate) active pharmaceutical ingredient (API) in detail. Different forms of Bedaquiline (fumarate) DMFs exist exist since differing nations have different regulations, such as Bedaquiline (fumarate) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bedaquiline (fumarate) DMF submitted to regulatory agencies in the US is known as a USDMF. Bedaquiline (fumarate) USDMF includes data on Bedaquiline (fumarate)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bedaquiline (fumarate) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bedaquiline (fumarate) suppliers with USDMF on PharmaCompass.
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