Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.
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01 1Atman Pharmaceuticals
02 1Pharm-RX Chemical
03 2Granules India Limited
04 1Sanofi
05 1Transo-Pharm USA LLC
06 1LGM Pharma
07 1Transo-Pharm Handels GmbH
08 1Rochem International Inc
09 1DKSH
10 1Jai Radhe Sales
11 1Tenatra Chemie
12 2Synthokem Labs
13 1Chunghwa Chemical Synthesis & Biotech
14 1Biesterfeld AG
15 1Biesterfeld Spezialchemie GmbH
16 2Boehringer Ingelheim GmbH
17 1CHEMSPEC CHEMICALS PVT LTD
18 1CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORP
19 1Chemvin Pharma
20 1Delta Synthetic Co. Ltd
21 1Dr. Raju’s Pharma Solutions
22 1Gennex Laboratories
23 1Gurvey & Berry
24 1Harman Finochem
25 1IWAKI SEIYAKU
26 1LifeFirst Pharma
27 1NAM Group
28 1Ningbo Smart Pharmaceutical
29 1Omshri Labs
30 2PAN DRUGS LTD
31 1Remedy Labs
32 1Rhodia Opérations S.A.S. FR 93306 Aubervilliers
33 1Rumit Group of Companies
34 1S.S.Pharmachem
35 1Seven Star Pharmaceutical
36 1Smilax Laboratories Limited
37 1Stellar Chemical Laboratories PVT Limited
38 1Unilab Chemicals & Pharmaceuticals
39 1Yamamoto Corporation
40 1Yonezawa Hamari Chemicals\
41 1Zhejiang Haizhou Jianfeng
42 1Zhejiang Jianfeng Haizhou
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01 1Canada
02 4China
03 2France
04 5Germany
05 22India
06 3Japan
07 1Switzerland
08 3Taiwan
09 5U.S.A
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01 6Active
02 12Inactive
03 30Blank
01 1Expired
02 8Valid
03 1Withdrawn by Holder
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01 1217MF10558
02 1217MF10885
03 1218MF10772
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01 1WC-0020n
02 1WC-0028
03 1WC-0116
04 1WC-0358
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-19
Pay. Date : 2014-03-11
DMF Number : 14372
Submission : 1999-08-30
Status : Active
Type : II
Certificate Number : R0-CEP 2021-332 - Rev 00
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 615
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0028
Address of the Firm :
NDC Package Code : 62207-500
Start Marketing Date : 2017-08-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (95mg/100mg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India
Available Reg Filing : BR, ASMF |
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 : 4989
Submission : 1983-06-28
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-08
Pay. Date : 2013-09-12
DMF Number : 10413
Submission : 1993-08-13
Status : Active
Type : II
Certificate Number : R1-CEP 1999-088 - Rev 05
Issue Date : 2018-06-26
Type : Chemical
Substance Number : 615
Status : Valid
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0020n
Address of the Firm :
NDC Package Code : 58343-0130
Start Marketing Date : 2013-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14234
Submission : 1999-06-24
Status : Inactive
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status : Active
Type : II
Certificate Number : R1-CEP 2009-201 - Rev 03
Issue Date : 2018-11-27
Type : Chemical
Substance Number : 615
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0116
Address of the Firm :
NDC Package Code : 62207-500
Start Marketing Date : 2017-08-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (95mg/100mg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India
Available Reg Filing : BR, ASMF |
Certificate Number : CEP 2019-065 - Rev 01
Issue Date : 2025-01-15
Type : Chemical
Substance Number : 615
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-14
Written Confirmation Number : WC-0358
Address of the Firm :
NDC Package Code : 58343-0130
Start Marketing Date : 2013-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16122
Submission : 2002-09-04
Status : Active
Type : II
Certificate Number : R1-CEP 2008-275 - Rev 04
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 615
Status : Valid
NDC Package Code : 66652-2101
Start Marketing Date : 2011-04-06
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 : 29179
Submission : 2015-03-13
Status : Active
Type : II
NDC Package Code : 65072-0501
Start Marketing Date : 2009-11-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-14
Pay. Date : 2013-11-29
DMF Number : 5809
Submission : 1985-04-11
Status : Active
Type : II
Certificate Number : R1-CEP 2009-351 - Rev 02
Issue Date : 2020-06-18
Type : Chemical
Substance Number : 615
Status : Valid
Registration Number : 218MF10772
Registrant's Address : 15, Minsheng St. , Tucheng Dist. , New Taipei City 23679, Taiwan (R.O.C.)
Initial Date of Registration : 2006-09-22
Latest Date of Registration :
NDC Package Code : 60203-1001
Start Marketing Date : 2002-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22840
Submission : 2009-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18029
Submission : 2005-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5423
Submission : 1984-05-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25752
Submission : 2012-02-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26324
Submission : 2012-09-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9262
Submission : 1991-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5972
Submission : 1985-08-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15507
Submission : 2001-06-28
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-194 - Rev 03
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 615
Status : Valid
Certificate Number : CEP 2024-189 - Rev 00
Issue Date : 2024-11-20
Type : Chemical
Substance Number : 615
Status : Valid
NDC Package Code : 71747-003
Start Marketing Date : 2022-08-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 4866
Submission : 1983-03-08
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 : 10988
Submission : 1994-07-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Oresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oresol, including repackagers and relabelers. The FDA regulates Oresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oresol 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 Oresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oresol supplier is an individual or a company that provides Oresol active pharmaceutical ingredient (API) or Oresol finished formulations upon request. The Oresol suppliers may include Oresol API manufacturers, exporters, distributors and traders.
click here to find a list of Oresol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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