01 1Aurobindo Pharma Limited
02 1Hetero Drugs
03 2MSN Laboratories
01 4India
01 3Active
02 1Blank
01 4Blank
01 4Blank
01 1WC-0383
02 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-19
Pay. Date : 2018-04-04
DMF Number : 32535
Submission : 2018-03-03
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383
Address of the Firm :
NDC Package Code : 69766-046
Start Marketing Date : 2018-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-16
Pay. Date : 2018-04-04
DMF Number : 32562
Submission : 2018-03-21
Status : Active
Type : II
NDC Package Code : 69766-046
Start Marketing Date : 2018-03-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-29
Pay. Date : 2018-11-30
DMF Number : 33405
Submission : 2018-12-01
Status : Active
Type : II
NDC Package Code : 59651-274
Start Marketing Date : 2024-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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.
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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.
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