Minakem is manufacturing small molecules APIs including corticosteroids
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01 1Minakem (formerly Delmar Chemicals)
02 2Sanofi
03 1LGM Pharma
04 1Nuray Chemicals Private Limited
05 1Rochem International Inc
06 2ACS DOBFAR SPA
07 1American Chemical Products
08 2Chongqing Carelife Pharmaceutical
09 1Fuan Pharmaceutical
10 1Galenova
11 1Hangzhou Think Chemical Co.Ltd
12 1Hangzhou Zhongmei Huadong Pharmaceutical
13 1Hanways Chempharm
14 1Hebei AiYoung Pharmaceutical Technology
15 1Hengdian Group
16 1Hubei Yitai Pharmaceutical Co. , Ltd.
17 1Letco Medical
18 1Medisca
19 1Parth Antibiotics
20 1Pcca
21 2Pfizer Inc
22 1Suzhou no. 4 Pharmaceutical Factory
23 1Tecoland Corporation
24 1Trifarma
25 2UQUIFA
26 1Unipex
27 1Xenex Labs
28 1Xinyu Pharmaceutical
29 1Zhejiang Candorly Pharmaceutical
30 2Zhejiang Hisoar Pharmaceutical
31 2Zhejiang Tiantai Pharmaceutical
32 1Zhejiang Wepon Pharmaceutical
33 1Zydus Lifesciences
34 1Blank
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01 3Canada
02 17China
03 3France
04 3India
05 3Italy
06 2Spain
07 8U.S.A
08 1United Kingdom
09 1Blank
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01 11Active
02 7Inactive
03 23Blank
01 1Expired
02 8Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 2Withdrawn by Holder
05 29Blank
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01 1218MF10538
02 1223MF10058
03 1226MF10069
04 1226MF10130
05 1229MF10180
06 1303MF10045
07 35Blank
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01 1WC-0084
02 40Blank
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01 120210209-210-J-618
02 40Blank
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01 138779-0006
02 239635-0001
03 146204-0120
04 149711-0116
05 151927-0273
06 152946-0603
07 158598-0003
08 162991-3171
09 165841-180
10 167321-302
11 168981-026
12 179572-007
13 28Blank
01 41Blank
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 : 13705
Submission : 1998-09-01
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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 : 13725
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-11-30
Pay. Date : 2016-08-02
DMF Number : 17422
Submission : 2004-05-09
Status : Active
Type : II
Certificate Number : CEP 2003-060 - Rev 07
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 996
Status : Valid
NDC Package Code : 39635-0001
Start Marketing Date : 2024-11-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-16
Pay. Date : 2024-11-12
DMF Number : 24358
Submission : 2010-11-08
Status : Active
Type : II
Certificate Number : CEP 2011-019 - Rev 02
Issue Date : 2024-11-27
Type : Chemical
Substance Number : 996
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32255
Submission : 2017-11-28
Status : Active
Type : II
Certificate Number : CEP 2022-145 - Rev 00
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 996
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-12
Pay. Date : 2013-01-23
DMF Number : 14412
Submission : 1999-09-23
Status : Active
Type : II
Certificate Number : R1-CEP 2000-097 - Rev 05
Issue Date : 2023-06-09
Type : Chemical
Substance Number : 996
Status : Valid
Registration Number : 226MF10069
Registrant's Address : Mallorca, 262, 3rd floor 08008 Barcelona Spain
Initial Date of Registration : 2014-03-11
Latest Date of Registration :
NDC Package Code : 49711-0116
Start Marketing Date : 2009-10-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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