Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 1Metrochem API Private Limited
02 1USV Private Limited
03 1TAPI Technology & API Services
04 1Aurobindo Pharma Limited
05 1Hetero Drugs
06 1Lupin Ltd
07 1MSN Laboratories
08 1Solara Active Pharma Sciences
09 1Teva Pharmaceutical Industries
10 1Zhejiang Ausun Pharmaceutical
01 1China
02 7India
03 2Israel
01 5Active
02 5Blank
01 10Blank
01 10Blank
01 1WC-0002A3
02 9Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37632
Submission : 2023-02-26
Status : Active
Type : II
NDC Package Code : 42765-051
Start Marketing Date : 2023-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-03
Valid Till : 2025-05-25
Written Confirmation Number : WC-0002A3
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-08
Pay. Date : 2022-02-25
DMF Number : 36827
Submission : 2022-02-25
Status : Active
Type : II
NDC Package Code : 59651-662
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-17
Pay. Date : 2021-12-15
DMF Number : 36618
Submission : 2022-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38135
Submission : 2023-03-25
Status : Active
Type : II
NDC Package Code : 14501-0115
Start Marketing Date : 2023-03-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-09
Pay. Date : 2022-05-26
DMF Number : 36729
Submission : 2022-03-31
Status : Active
Type : II
A Migalastat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Migalastat, including repackagers and relabelers. The FDA regulates Migalastat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Migalastat 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 Migalastat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Migalastat supplier is an individual or a company that provides Migalastat active pharmaceutical ingredient (API) or Migalastat finished formulations upon request. The Migalastat suppliers may include Migalastat API manufacturers, exporters, distributors and traders.
click here to find a list of Migalastat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 10 companies offering Migalastat
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