Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Metrochem API Private Limited
03 1Shandong Loncom Pharmaceutical
04 1Aurobindo Pharma Limited
05 1CHEMO
06 1HONOUR LAB LTD
07 1Hetero Drugs
08 1Hikal
09 2MSN Laboratories
10 1Morepen Laboratories
01 1China
02 9India
03 1Spain
01 7Active
02 4Blank
01 11Blank
01 11Blank
01 11Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-29
Pay. Date : 2021-08-18
DMF Number : 35991
Submission : 2021-06-28
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-25
Pay. Date : 2021-09-14
DMF Number : 36283
Submission : 2021-09-30
Status : Active
Type : II
NDC Package Code : 69037-0068
Start Marketing Date : 2017-12-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35787
Submission : 2021-08-31
Status : Active
Type : II
NDC Package Code : 14501-0107
Start Marketing Date : 2021-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36939
Submission : 2022-03-31
Status : Active
Type : II
NDC Package Code : 14501-0107
Start Marketing Date : 2021-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-10
Pay. Date : 2021-08-02
DMF Number : 36152
Submission : 2021-08-05
Status : Active
Type : II
NDC Package Code : 59651-598
Start Marketing Date : 2023-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37359
Submission : 2022-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34850
Submission : 2020-05-01
Status : Active
Type : II
NDC Package Code : 66651-926
Start Marketing Date : 2019-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Ertugliflozin L-Pyroglutamic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ertugliflozin L-Pyroglutamic Acid, including repackagers and relabelers. The FDA regulates Ertugliflozin L-Pyroglutamic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ertugliflozin L-Pyroglutamic Acid 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 Ertugliflozin L-Pyroglutamic Acid supplier is an individual or a company that provides Ertugliflozin L-Pyroglutamic Acid active pharmaceutical ingredient (API) or Ertugliflozin L-Pyroglutamic Acid finished formulations upon request. The Ertugliflozin L-Pyroglutamic Acid suppliers may include Ertugliflozin L-Pyroglutamic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Ertugliflozin L-Pyroglutamic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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