01 1Aurobindo Pharma Limited
02 2Cambrex Corporation
03 1Hetero Drugs
04 2MSN Laboratories
01 4India
02 2U.S.A
01 3Active
02 3Blank
01 6Blank
01 6Blank
01 1WC-0383
02 5Blank
01 6Blank
01 259116-4290
02 159651-274
03 169766-046
04 169766-047
05 1Blank
01 6Blank
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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 : 69766-047
Start Marketing Date : 2018-03-21
End Marketing Date : 2025-12-31
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 : 2025-12-31
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
NDC Package Code : 59116-4290
Start Marketing Date : 2013-03-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59116-4290
Start Marketing Date : 2013-03-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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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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.
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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.
We have 4 companies offering Naloxegol
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