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
A Naloxegol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxegol, including repackagers and relabelers. The FDA regulates Naloxegol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxegol 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 Naloxegol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxegol supplier is an individual or a company that provides Naloxegol active pharmaceutical ingredient (API) or Naloxegol finished formulations upon request. The Naloxegol suppliers may include Naloxegol API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxegol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naloxegol DMF (Drug Master File) is a document detailing the whole manufacturing process of Naloxegol active pharmaceutical ingredient (API) in detail. Different forms of Naloxegol DMFs exist exist since differing nations have different regulations, such as Naloxegol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naloxegol DMF submitted to regulatory agencies in the US is known as a USDMF. Naloxegol USDMF includes data on Naloxegol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naloxegol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naloxegol suppliers with USDMF on PharmaCompass.
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