Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
01 1Minakem
02 1Vamsi Labs
03 1Coral Drugs Private Limited
04 2Axplora
05 1Minakem (formerly Delmar Chemicals)
06 1Transo-Pharm USA LLC
07 1LGM Pharma
08 2Aspen API
09 2Fermion Oy
10 1Metrochem API Private Limited
11 1Symbiotec Pharmalab
12 1DKSH
13 1Jai Radhe Sales
14 1Aarti Pharmalabs
15 1Cennet Biopharma
16 1Hubei Gedian Humanwell Pharmaceutical
17 1Nortec Quimica
18 1Octavius Pharma Pvt. Ltd
19 1Amphastar Pharmaceuticals
20 1Apotex Pharmachem
21 1Aspire Lifesciences Pvt Ltd
22 1AstraZeneca
23 1Atomgrid
24 1Aurisco Pharmaceutical
25 1Avik Pharmaceutical Limited
26 1Bajaj Healthcare
27 1Beijing Breathgreen Healthcare
28 2Breathgreen Pharmaceuticals
29 1CHEMO
30 2Cipla
31 2Curia
32 1DEAFARMA
33 1Guangzhou Tosun Pharmaceutical
34 1Henan Lihua Pharmaceutical
35 1Huvepharma Italia S.r.l
36 2Industriale Chimica
37 1Jayco Chemical Industries
38 1Micro Orgo Chem
39 1Murli Krishna Pharma
40 2NEWCHEM SPA
41 1SM BIOMED
42 1Sicor Societa Italiana Corticosteroidi Srl
43 1Sicor de Mexico
44 2Sterling Spa
45 1Sudarshan Pharma
46 1Sun Pharmaceutical Industries Limited
47 1Swati Spentose
48 1Symbiotica Specialty Ingredients
49 3Teva API
50 1Teva Pharmaceutical Industries
51 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
52 1Titan Laboratories
53 1Zhejiang Xianju Pharmaceutical Co. Ltd
54 1Zim Laboratories
01 1Brazil
02 2Canada
03 7China
04 2Finland
05 1France
06 2Germany
07 22India
08 4Israel
09 9Italy
10 2Malaysia
11 1Mexico
12 2Netherlands
13 1Spain
14 1Switzerland
15 7U.S.A
16 1United Kingdom
01 23Active
02 1Inactive
03 41Blank
01 1Expired
02 24Valid
03 40Blank
01 1219MF10041
02 1227MF10218
03 1228MF10196
04 1229MF10129
05 1301MF10045
06 1301MF10061
07 1305MF10040
08 58Blank
01 1HB230032
02 1WC-0009
03 1WC-0099
04 1WC-0144
05 1WC-0155
06 1WC-0168
07 1WC-0169
08 58Blank
Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-03
Pay. Date : 2017-02-10
DMF Number : 28441
Submission : 2014-06-20
Status : Active
Type : II
Certificate Number : R1-CEP 2010-190 - Rev 03
Issue Date : 2020-06-09
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 301MF10045
Registrant's Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Initial Date of Registration : 2019-08-20
Latest Date of Registration : --
NDC Package Code : 49927-0003
Start Marketing Date : 2006-02-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2023-07-19
Registration Number : 20221124-209-J-1409(A)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640, France
Available Reg Filing : CA, ID |
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0393
Start Marketing Date : 2021-01-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30534
Submission : 2017-02-02
Status : Active
Type : II
Certificate Number : R1-CEP 2016-020 - Rev 00
Issue Date : 2022-11-15
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
NDC Package Code : 49076-6111
Start Marketing Date : 2017-11-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-16
Pay. Date : 2013-05-03
DMF Number : 18910
Submission : 2005-10-26
Status : Active
Type : II
Certificate Number : R1-CEP 2000-051 - Rev 02
Issue Date : 2010-05-04
Type : Chemical
Substance Number : 1075
Status : Valid
NDC Package Code : 46439-8719
Start Marketing Date : 2005-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-06-01
Registration Number : 20200601-209-J-448
Manufacturer Name : Farmabios SpA@Microchem Srl
Manufacturer Address : 27027, via Pavia 1, GROPELLO CAIROLI-(PV), Italy@Via Turati, 2-29017 Fiorenzuola D'arda (PC), Italy
Available Reg Filing : SAU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10493
Submission : 1993-09-23
Status : Active
Type : II
Certificate Number : R0-CEP 2021-491 - Rev 01
Issue Date : 2023-02-10
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 305MF10040
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2023-03-29
Latest Date of Registration : --
NDC Package Code : 60870-0466
Start Marketing Date : 1993-09-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-11-24
Registration Number : 20221124-209-J-1410
Manufacturer Name : Aspen Oss BV@AstraZeneca AB
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands@Forskargatan 18, Sodertalje, 151 36, Sweden
Certificate Number : R0-CEP 2020-341 - Rev 00
Issue Date : 2022-02-22
Type : Chemical
Substance Number : 1075
Status : Valid
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