01 1Aurobindo Pharma Limited
02 2MSN Laboratories
01 1NALOXEGOL OXALATE
02 1NALOXEGOL OXALATE (PREMIX)
03 1NALOXEGOL OXALATE PREMIX
01 3India
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-29
Pay. Date : 2018-11-30
DMF Number : 33405
Submission : 2018-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-16
Pay. Date : 2018-04-04
DMF Number : 32562
Submission : 2018-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-19
Pay. Date : 2018-04-04
DMF Number : 32535
Submission : 2018-03-03
Status : Active
Type : II
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PharmaCompass offers a list of Naloxegol Oxalate 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 Naloxegol Oxalate manufacturer or Naloxegol Oxalate supplier for your needs.
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PharmaCompass also assists you with knowing the Naloxegol Oxalate API Price utilized in the formulation of products. Naloxegol Oxalate API Price is not always fixed or binding as the Naloxegol Oxalate Price is obtained through a variety of data sources. The Naloxegol Oxalate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MOVANTIK manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MOVANTIK, including repackagers and relabelers. The FDA regulates MOVANTIK manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MOVANTIK API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A MOVANTIK supplier is an individual or a company that provides MOVANTIK active pharmaceutical ingredient (API) or MOVANTIK finished formulations upon request. The MOVANTIK suppliers may include MOVANTIK API manufacturers, exporters, distributors and traders.
click here to find a list of MOVANTIK suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MOVANTIK DMF (Drug Master File) is a document detailing the whole manufacturing process of MOVANTIK active pharmaceutical ingredient (API) in detail. Different forms of MOVANTIK DMFs exist exist since differing nations have different regulations, such as MOVANTIK USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MOVANTIK DMF submitted to regulatory agencies in the US is known as a USDMF. MOVANTIK USDMF includes data on MOVANTIK's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MOVANTIK USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MOVANTIK suppliers with USDMF on PharmaCompass.
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