Minakem is manufacturing small molecules APIs including corticosteroids
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 1Beijing Mesochem Technology
09 2Chongqing Carelife Pharmaceutical
10 1Fuan Pharmaceutical
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 1Parth Antibiotics
18 2Pfizer Inc
19 1Suzhou no. 4 Pharmaceutical Factory
20 1Tecoland Corporation
21 1Trifarma
22 2UQUIFA
23 1Unipex
24 1Xinyu Pharmaceutical
25 1Zhejiang Candorly Pharmaceutical
26 2Zhejiang Hisoar Pharmaceutical
27 1Zhejiang Tiantai Pharmaceutical
28 1Zhejiang Wepon Pharmaceutical
29 1Zydus Lifesciences
01 1Canada
02 17China
03 3France
04 3India
05 3Italy
06 2Spain
07 6U.S.A
01 11Active
02 8Inactive
03 16Blank
01 1Expired
02 8Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 2Withdrawn by Holder
05 23Blank
01 1218MF10538
02 1223MF10058
03 1226MF10069
04 1226MF10130
05 1229MF10180
06 1303MF10045
07 29Blank
01 1WC-0084
02 34Blank
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 : 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 : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 2014-03-18
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 : 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
NDC Package Code : 69132-003
Start Marketing Date : 2017-09-28
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 : 18533
Submission : 2005-07-22
Status : Inactive
Type : II
Certificate Number : R0-CEP 2003-177 - Rev 01
Issue Date : 2010-01-14
Type : Chemical
Substance Number : 996
Status : Expired
NDC Package Code : 49711-0116
Start Marketing Date : 2009-10-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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