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