Aspen API. More than just an API.
01 1Aspen API
02 3Symbiotec Pharmalab
03 1Sanofi
04 1AASraw Biochemical Technology Co., Ltd
05 1ASG Biochem
06 1Bayer AG
07 1Biovet AD
08 1Nanjing Bold Chemical
09 1Pfizer Inc
10 1Steroid SpA
11 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
12 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Bulgaria
02 4China
03 1France
04 1Germany
05 4India
06 1Italy
07 1Netherlands
08 1U.S.A
01 4Active
02 4Inactive
03 6Blank
01 2Valid
02 12Blank
01 1304MF10082
02 13Blank
01 1WC-0161A2
02 2WC-0162A2
03 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3877
Submission : 1980-06-25
Status : Active
Type : II
NDC Package Code : 60870-0266
Start Marketing Date : 1980-04-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-26
Pay. Date : 2018-04-17
DMF Number : 26166
Submission : 2012-06-19
Status : Active
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0014
Start Marketing Date : 2010-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3781
Submission : 1980-04-15
Status : Inactive
Type : II
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0014
Start Marketing Date : 2010-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0014
Start Marketing Date : 2010-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32765
Submission : 2018-04-27
Status : Active
Type : II
Certificate Number : R1-CEP 2012-306 - Rev 00
Issue Date : 2019-03-15
Type : Chemical
Substance Number : 1048
Status : Valid
Registration Number : 304MF10082
Registrant's Address : Viale Spagna, 156 Cologno Monzese (MI) - ITALY
Initial Date of Registration : 2022-06-01
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-04
Pay. Date : 2015-08-26
DMF Number : 3391
Submission : 1978-10-31
Status : Active
Type : II
Certificate Number : R1-CEP 2001-155 - Rev 03
Issue Date : 2021-09-24
Type : Chemical
Substance Number : 1048
Status : Valid
NDC Package Code : 12866-1009
Start Marketing Date : 2017-05-12
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 : 23920
Submission : 2010-06-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27431
Submission : 2013-08-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4239
Submission : 1981-06-26
Status : Inactive
Type : II
A Testosterone Enanthate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone Enanthate, including repackagers and relabelers. The FDA regulates Testosterone Enanthate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone Enanthate 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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