Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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 3Fermion Oy
10 1Metrochem API Private Limited
11 1Symbiotec Pharmalab
12 1DKSH
13 1Jai Radhe Sales
14 1Aarti Pharmalabs
15 1Nortec Quimica
16 1Octavius Pharma Pvt. Ltd
17 3TAPI Technology & API Services
18 1Amphastar Pharmaceuticals
19 1Apotex Pharmachem
20 1Aspire Lifesciences Pvt Ltd
21 1AstraZeneca
22 1Atomgrid
23 1Aurisco Pharmaceutical
24 1Avik Pharmaceutical Limited
25 1Bajaj Healthcare
26 1Beijing Breathgreen Healthcare
27 2Breathgreen Pharmaceuticals
28 1CHEMO
29 2Cipla
30 2Curia
31 1DEAFARMA
32 1Guangzhou Tosun Pharmaceutical
33 1Henan Lihua Pharmaceutical
34 1Hubei Gedian Humanwell 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 1Shakti Lifescience
43 1Sicor Societa Italiana Corticosteroidi Srl
44 1Sicor de Mexico
45 2Sterling Spa
46 1Sudarshan Pharma
47 1Sun Pharmaceutical Industries Limited
48 1Swati Spentose
49 1Symbiotica Specialty Ingredients
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 3Finland
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 42Blank
01 1Expired
02 27Valid
03 38Blank
01 1219MF10041
02 1227MF10218
03 1228MF10196
04 1229MF10129
05 1301MF10045
06 1301MF10061
07 1305MF10040
08 59Blank
01 1HB230032
02 1WC-0009
03 1WC-0099
04 1WC-0144nA2
05 1WC-0155
06 1WC-0168
07 1WC-0169
08 59Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-03
Pay. Date : 2013-03-04
DMF Number : 20609
Submission : 2007-06-13
Status : Active
Type : II
Certificate Number : R1-CEP 2006-295 - Rev 04
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-0100
Start Marketing Date : 2001-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-29
Pay. Date : 2012-11-13
DMF Number : 10976
Submission : 1994-07-11
Status : Active
Type : II
Certificate Number : R0-CEP 2019-266 - Rev 00
Issue Date : 2022-03-09
Type : Chemical
Substance Number : 1075
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25615
Submission : 2011-12-20
Status : Active
Type : II
Certificate Number : R1-CEP 2005-174 - Rev 01
Issue Date : 2017-07-25
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 |
Certificate Number : R1-CEP 2016-043 - Rev 01
Issue Date : 2023-02-10
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 301MF10061
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2019-09-11
Latest Date of Registration : --
NDC Package Code : 60870-0466
Start Marketing Date : 1993-09-23
End Marketing Date : 2025-12-31
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 : CEP 2023-318 - Rev 00
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 1075
Status : Valid
Certificate Number : CEP 2023-192 - Rev 00
Issue Date : 2023-09-26
Type : Chemical
Substance Number : 1075
Status : Valid
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16932
Submission : 2003-10-28
Status : Active
Type : II
Certificate Number : R1-CEP 1997-067 - Rev 09
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 1075
Status : Valid
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 2014-051 - Rev 01
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 1075
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-03
Pay. Date : 2013-03-19
DMF Number : 22641
Submission : 2009-03-19
Status : Active
Type : II
Certificate Number : R1-CEP 2009-057 - Rev 00
Issue Date : 2015-10-07
Type : Chemical
Substance Number : 1075
Status : Valid
NDC Package Code : 64918-0204
Start Marketing Date : 2015-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : YuYu Pharmaceutical Co., Ltd.
Registration Date : 2022-08-09
Registration Number : 20220809-209-J-1324
Manufacturer Name : Sterling SpA@Microchem Srl
Manufacturer Address : Via della Carboneria 30(loc. Solomeo)-06073 Corciano Perugia, Italy@Via Turati, 2-29017 Fiorenzuola D'arda (PC), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-30
Pay. Date : 2018-07-17
DMF Number : 32195
Submission : 2017-10-25
Status : Active
Type : II
Certificate Number : R1-CEP 2000-038 - Rev 04
Issue Date : 2011-12-02
Type : Chemical
Substance Number : 1075
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-03
Pay. Date : 2013-09-27
DMF Number : 26445
Submission : 2013-09-30
Status : Active
Type : II
Certificate Number : CEP 2018-064 - Rev 01
Issue Date : 2024-08-14
Type : Chemical
Substance Number : 1075
Status : Valid
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38373
Submission : 2023-06-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39691
Submission : 2024-03-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-19
Pay. Date : 2013-09-03
DMF Number : 25319
Submission : 2011-08-22
Status : Active
Type : II
Certificate Number : R1-CEP 2009-185 - Rev 03
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 228MF10196
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2016-10-17
Latest Date of Registration : --
NDC Package Code : 24002-0001
Start Marketing Date : 2009-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-03-15
Registration Number : 20220315-209-J-1249
Manufacturer Name : Newchem SpA@MICROCHEM Srl
Manufacturer Address : Via Roveggia, 47-37136 Verona (VR), Italy@Via Turati, 2 – 29017 Fiorenzuola d'Arda (PC), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15877
Submission : 2002-04-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-152 - Rev 04
Issue Date : 2012-03-16
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 229MF10129
Registrant's Address : Via E. H. Grieg, 13,21047 Saronno (VARESE) ITALY
Initial Date of Registration : 2017-07-14
Latest Date of Registration : --
NDC Package Code : 63190-0060
Start Marketing Date : 2014-10-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Budesonide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Budesonide, including repackagers and relabelers. The FDA regulates Budesonide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Budesonide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Budesonide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Budesonide supplier is an individual or a company that provides Budesonide active pharmaceutical ingredient (API) or Budesonide finished formulations upon request. The Budesonide suppliers may include Budesonide API manufacturers, exporters, distributors and traders.
click here to find a list of Budesonide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 54 companies offering Budesonide
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?