Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
01 1Minakem
02 1ChemWerth Inc
03 1Minakem (formerly Delmar Chemicals)
04 1Transo-Pharm USA LLC
05 1LGM Pharma
06 1Shanghai Minbiotech
07 1Zeon Pharma Industries India Pvt Ltd
08 1ALP Pharm
09 2Cipla
10 1Eriochem S.A.
11 1Exopharm
12 1Guangzhou Hanfang Pharma. Co. Ltd
13 2Hansoh Pharma
14 1Hubei Honch Pharmaceutical
15 2Pierre Fabre
16 1Qilu Pharmaceutical
17 2Synbias Pharma Limited Liability Company
18 1Tecoland Corporation
19 1Zhejiang Hisun Pharmaceutical
20 1Blank
01 1Argentina
02 1Australia
03 1Canada
04 8China
05 3France
06 3India
07 4U.S.A
08 2Ukraine
09 1Blank
01 4Active
02 12Inactive
03 8Blank
01 1Expired
02 4Valid
03 3Withdrawn by Holder
04 16Blank
01 1218MF10576
02 1226MF10027
03 1303MF10150
04 1303MF10173
05 20Blank
01 1WC-0113
02 1WC-0138
03 22Blank
Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-23
Pay. Date : 2016-03-23
DMF Number : 14619
Submission : 1999-12-13
Status : Active
Type : II
Certificate Number : R1-CEP 2011-342 - Rev 00
Issue Date : 2018-08-06
Type : Chemical
Substance Number : 2107
Status : Valid
Registration Number : 303MF10150
Registrant's Address : Rue Fonds Jean Pa(^)ques, 8 1435 Mont-Saint-Guibert Belgium
Initial Date of Registration : 2021-09-17
Latest Date of Registration : --
NDC Package Code : 69910-0004
Start Marketing Date : 2015-06-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9477
Submission : 1991-11-25
Status : Active
Type : II
Certificate Number : R1-CEP 2004-297 - Rev 05
Issue Date : 2020-02-25
Type : Chemical
Substance Number : 2107
Status : Valid
Registration Number : 218MF10576
Registrant's Address : 16 rue Jean Rostand ZI de Clergous 81600 GAILLAC FRANCE
Initial Date of Registration : 2006-06-15
Latest Date of Registration : --
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-57-A-111-01
Manufacturer Name : Pierre Fabre Medicine
Manufacturer Address : Zone Industrielle des Clergous, 16 rue Jean Rostand - 81600 Gaillac, France
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9973
Submission : 1992-11-23
Status : Inactive
Type : II
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-57-A-111-01
Manufacturer Name : Pierre Fabre Medicine
Manufacturer Address : Zone Industrielle des Clergous, 16 rue Jean Rostand - 81600 Gaillac, France
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25783
Submission : 2012-02-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2016-009 - Rev 01
Issue Date : 2018-06-29
Type : Chemical
Substance Number : 2107
Status : Expired
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