Minakem is manufacturing small molecules APIs including corticosteroids
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01 1Minakem (formerly Delmar Chemicals)
02 1FARMAK, a.s
03 2Dr. Reddy's Laboratories
04 1Gonane Pharma
05 1Jai Radhe Sales
06 1Faran Shimi Pharmaceutical
07 1HRV Global Life Sciences
08 1Tenatra Chemie
09 1Atman Pharma Private Limited
10 1Abbott Laboratories
11 1Alembic Pharmaceuticals Limited
12 1Aspire Lifesciences Pvt Ltd
13 1Atom Pharma
14 1Bazayan & Co
15 2CHEMO
16 1Cilag AG
17 1DEAFARMA
18 1Divis Laboratories
19 1Emcure Pharmaceuticals
20 2Lunan Pharmaceutical
21 2MSN Laboratories
22 1Maprimed
23 1Nishchem International Pvt. Ltd
24 1Nosch Labs Pvt
25 1Quimica Sintetica
26 1Recordati
27 1Sanpra Synthesis
28 1Saurav Chemicals
29 1Shamrock Medicaments
30 1Symed Labs
31 1UQUIFA
32 1Vasista
33 2Vasudha Pharma Chem
34 3Blank
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01 1Argentina
02 1Canada
03 2China
04 1Czech Republic
05 24India
06 1Iran
07 2Italy
08 4Spain
09 1Switzerland
10 1U.S.A
11 3Blank
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01 11Active
02 7Inactive
03 23Blank
01 5Valid
02 1Withdrawn by Holder
03 35Blank
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01 41Blank
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01 1WC-0021
02 1WC-0021n
03 1WC-0027
04 1WC-0034
05 2WC-0070
06 1WC-0072
07 1WC-0171
08 1WC-0226
09 1WC-390A4
10 31Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12558
Submission : 1997-06-17
Status : Active
Type : II
NDC Package Code : 63278-1056
Start Marketing Date : 2000-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-04
DMF Number : 14603
Submission : 1999-11-23
Status : Active
Type : II
Certificate Number : R1-CEP 2008-069 - Rev 05
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 1755
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-11-30
Written Confirmation Number : WC-390A4
Address of the Firm :
NDC Package Code : 55111-014
Start Marketing Date : 1999-11-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2018-08-13
Registration Number : 20050831-61-C-189-04(8)
Manufacturer Name : Dr. Reddy's Laboratories Ltd.
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Village, Jinnaram Mandal, Sangareddy District, Telangana, 502325, India
Available Reg Filing : CN, BR, RU |
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
NDC Package Code : 55111-014
Start Marketing Date : 1999-11-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2018-08-13
Registration Number : 20050831-61-C-189-04(8)
Manufacturer Name : Dr. Reddy's Laboratories Ltd.
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Village, Jinnaram Mandal, Sangareddy District, Telangana, 502325, India
Available Reg Filing : CN, BR, RU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2013-03-04
DMF Number : 26870
Submission : 2013-02-07
Status : Active
Type : II
Certificate Number : R1-CEP 2015-046 - Rev 00
Issue Date : 2021-06-04
Type : Chemical
Substance Number : 1755
Status : Valid
Date of Issue : 2022-11-28
Valid Till : 2025-09-08
Written Confirmation Number : WC-0072
Address of the Firm :
NDC Package Code : 66022-0117
Start Marketing Date : 1992-11-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2021-05-14
Registration Number : 20200227-61-C-384-14(1)
Manufacturer Name : Symed Labs Limited(Unit II) @Symed Labs Limited(Unit VI)
Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri District-500 055 Telangana State India@Sy. No. 744, 745, 750, 751, 752 & 753, Mandollagudem Village Choutuppal Mandal, Yadadri District, Telangana, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-15
Pay. Date : 2018-11-14
DMF Number : 29015
Submission : 2015-01-14
Status : Active
Type : II
Certificate Number : R1-CEP 2014-369 - Rev 01
Issue Date : 2023-03-03
Type : Chemical
Substance Number : 1755
Status : Valid
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
NDC Package Code : 66577-016
Start Marketing Date : 1997-05-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-26
Pay. Date : 2012-12-04
DMF Number : 21693
Submission : 2008-05-28
Status : Active
Type : II
Certificate Number : R1-CEP 2008-144 - Rev 03
Issue Date : 2019-06-24
Type : Chemical
Substance Number : 1755
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0010
Start Marketing Date : 2010-03-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2019-07-11
Registration Number : 20190711-61-C-379-13
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-08
Pay. Date : 2012-11-21
DMF Number : 20728
Submission : 2007-07-26
Status : Active
Type : II
Certificate Number : R1-CEP 2007-214 - Rev 01
Issue Date : 2020-10-01
Type : Chemical
Substance Number : 1755
Status : Valid
NDC Package Code : 12711-5990
Start Marketing Date : 2010-07-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-10
Pay. Date : 2015-09-29
DMF Number : 29840
Submission : 2015-09-30
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-20
Pay. Date : 2017-01-23
DMF Number : 11980
Submission : 1996-05-24
Status : Active
Type : II
NDC Package Code : 53069-0620
Start Marketing Date : 2017-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2019-05-13
Registration Number : 20071204-61-C-230-06(6)
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : 28805, C/ Dulcinea s/n, Alcala de Henares, Madrid, Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22413
Submission : 2009-01-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-26
Pay. Date : 2022-09-28
DMF Number : 37481
Submission : 2022-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11736
Submission : 1995-11-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14340
Submission : 1999-08-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14209
Submission : 1999-06-17
Status : Inactive
Type : II
Certificate Number : R0-CEP 2015-190 - Rev 02
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 1755
Status : Withdrawn by Holder
Registrant Name : Samjin Pharmaceutical Co., Ltd.
Registration Date : 2016-08-09
Registration Number : 20050831-61-C-187-03(9)
Manufacturer Name : Union Quimico Farmaceutica SA
Manufacturer Address : Poli Industrial El Pla Av. Puigcerda, 9 C-17, km 17.4 08185 Llica de Vall (Barcelona) Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11507
Submission : 1995-05-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11799
Submission : 1996-01-04
Status : Inactive
Type : II
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
NDC Package Code : 66577-016
Start Marketing Date : 1997-05-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027
Address of the Firm :
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0171
Address of the Firm :
NDC Package Code : 43235-0001
Start Marketing Date : 2017-07-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Dongkwang Pharmaceutical Co., Ltd.
Registration Date : 2018-06-21
Registration Number : 20170926-61-C-362-12(1)
Manufacturer Name : Saurav Chemicals Limited
Manufacturer Address : Village Bhagwanpura, Tehsil Derabassi, District Sahibzada Ajit Singh Nagar, Punjab, India
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm :
NDC Package Code : 14501-0010
Start Marketing Date : 2010-03-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2019-07-11
Registration Number : 20190711-61-C-379-13
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40790
Submission : 2024-11-13
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10372
Submission : 1993-11-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12782
Submission : 1997-12-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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