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 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.
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