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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33635
Submission : 2019-02-27
Status : Active
Type : II
Date of Issue : 2019-06-17
Valid Till : 2022-06-16
Written Confirmation Number : WC-0050
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 35690
Submission : 2021-02-27
Status : Active
Type : II
Date of Issue : 2021-12-24
Valid Till : 2022-06-16
Written Confirmation Number : WC-0050A4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-06-04
DMF Number : 27146
Submission : 2013-06-26
Status : Active
Type : II
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
NDC Package Code : 65015-830
Start Marketing Date : 2015-02-20
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-02
Pay. Date : 2020-11-02
DMF Number : 34165
Submission : 2020-11-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-05-09
DMF Number : 27083
Submission : 2013-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33486
Submission : 2019-07-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-21
Pay. Date : 2013-06-10
DMF Number : 27189
Submission : 2013-06-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-07-11
DMF Number : 27239
Submission : 2013-06-29
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0039
Start Marketing Date : 2013-06-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 29299
Submission : 2015-05-11
Status : Active
Type : II
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DMF Number : 30054
Submission : 2015-12-31
Status : Inactive
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Date of Issue : 2022-06-20
Valid Till : 2025-08-08
Written Confirmation Number : WC-0113
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GDUFA
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DMF Number : 27268
Submission : 2013-07-02
Status : Inactive
Type : II
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DMF Number : 27201
Submission : 2013-07-05
Status : Inactive
Type : II
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0097
Address of the Firm :
Date of Issue : 2021-12-24
Valid Till : 2022-08-15
Written Confirmation Number : WC-0022A3
Address of the Firm :
NDC Package Code : 50370-0039
Start Marketing Date : 2013-06-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-09-27
Valid Till : 2022-07-02
Written Confirmation Number : WC-0097A3
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A Saxagliptin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Saxagliptin Hydrochloride, including repackagers and relabelers. The FDA regulates Saxagliptin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Saxagliptin Hydrochloride 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 Saxagliptin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Saxagliptin Hydrochloride supplier is an individual or a company that provides Saxagliptin Hydrochloride active pharmaceutical ingredient (API) or Saxagliptin Hydrochloride finished formulations upon request. The Saxagliptin Hydrochloride suppliers may include Saxagliptin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Saxagliptin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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