Aspen API. More than just an API.
01 1Aspen API
02 2Symbiotec Pharmalab
03 1Hubei Gedian Humanwell Pharmaceutical
04 1Sanofi
05 1LGM Pharma
06 1Dr. Reddy's Laboratories
07 1Gonane Pharma
08 1Jai Radhe Sales
09 1Pfizer CentreOne
10 13M Company
11 1AASraw Biochemical Technology Co., Ltd
12 1ASG Biochem
13 2Bayer AG
14 1Biovet AD
15 1Cipla
16 1Curia
17 1Fujifilm Diosynth Biotechnologies
18 1Indo Phyto Chemicals Private Ltd
19 3Ipca Laboratories
20 1Laboratorio Syntex S.A
21 1Lupin Ltd
22 1Nanjing Bold Chemical
23 1Productos Quimicos Naturales
24 1Qinhuangdao Zizhu Pharmaceutical
25 1SIGMA TAU
26 1Sun Pharmaceutical Industries Limited
27 1Swati Spentose
28 1VM Life Science
29 1Yicheng Goto Pharmaceuticals Co Ltd
30 1Zhejiang Xianju Pharmaceutical Co. Ltd
31 2Blank
01 1Argentina
02 1Bulgaria
03 6China
04 1France
05 2Germany
06 15India
07 1Mexico
08 1Netherlands
09 5U.S.A
10 1United Kingdom
11 2Blank
01 10Active
02 12Inactive
03 14Blank
01 8Valid
02 28Blank
01 36Blank
01 1WC-0161A2
02 1WC-0162
03 1WC-0168
04 1WC-0402
05 1WC-0402A2
06 1WC-0402A3
07 30Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 11826
Submission : 1996-01-03
Status : Active
Type : II
Certificate Number : R1-CEP 2000-037 - Rev 05
Issue Date : 2020-03-17
Type : Chemical
Substance Number : 1373
Status : Valid
NDC Package Code : 60870-0251
Start Marketing Date : 1980-04-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29869
Submission : 2015-09-30
Status : Active
Type : II
Certificate Number : R1-CEP 2015-314 - Rev 01
Issue Date : 2023-06-30
Type : Chemical
Substance Number : 1373
Status : Valid
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0009
Start Marketing Date : 2010-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-05
Pay. Date : 2023-05-26
DMF Number : 37074
Submission : 2022-09-07
Status : Active
Type : II
Certificate Number : CEP 2022-181 - Rev 01
Issue Date : 2024-07-23
Type : Chemical
Substance Number : 1373
Status : Valid
NDC Package Code : 70492-002
Start Marketing Date : 2018-08-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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 : 4512
Submission : 1982-04-23
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-08
Pay. Date : 2013-08-21
DMF Number : 23671
Submission : 2010-06-04
Status : Active
Type : II
NDC Package Code : 30007-837
Start Marketing Date : 2010-01-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 3190
Submission : 1978-04-28
Status : Active
Type : II
Certificate Number : R1-CEP 2000-307 - Rev 03
Issue Date : 2021-02-10
Type : Chemical
Substance Number : 1373
Status : Valid
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0009
Start Marketing Date : 2010-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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