Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1Coral Drugs Private Limited
02 3Symbiotec Pharmalab
03 1Gonane Pharma
04 2Sanofi
05 1Aspen API
06 1ASG Biochem
07 1Balaji Corporation
08 3Bayer AG
09 1Fareva
10 2Gedeon Richter
11 1Guangzhou Tosun Pharmaceutical
12 1Indo Phyto Chemicals Private Ltd
13 1Ipca Laboratories
14 1Lupin Ltd
15 1Merck & Co
16 1Mitsubishi Corporation
17 1Mortar & Pestle
18 1Naari
19 2VM Life Science
20 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
21 2Zhejiang Xianju Pharmaceutical Co. Ltd
22 3Blank
01 4China
02 2France
03 3Germany
04 2Hungary
05 14India
06 1Japan
07 1Luxembourg
08 1Netherlands
09 1U.S.A
10 3Blank
01 5Active
02 10Inactive
03 17Blank
01 7Valid
02 1Withdrawn by Holder
03 24Blank
01 1218MF10846
02 1219MF10281
03 1228MF10157
04 1306MF10093
05 28Blank
01 1WC-0161A2
02 2WC-0162A2
03 1WC-0297
04 1WC-0402A2
05 1WC-297
06 26Blank
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : 1920
Submission : 1972-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-20
DMF Number : 3849
Submission : 1980-05-22
Status : Active
Type : II
Certificate Number : R1-CEP 1996-041 - Rev 07
Issue Date : 2022-11-25
Type : Chemical
Substance Number : 234
Status : Valid
Registration Number : 218MF10846
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-10-20
Latest Date of Registration : --
NDC Package Code : 60870-0235
Start Marketing Date : 1980-04-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
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 : 8239
Submission : 1989-10-05
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-05
Pay. Date : 2013-09-18
DMF Number : 24416
Submission : 2011-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2011-094 - Rev 03
Issue Date : 2022-09-05
Type : Chemical
Substance Number : 234
Status : Valid
NDC Package Code : 24823-910
Start Marketing Date : 2011-09-21
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 : 35803
Submission : 2021-03-30
Status : Active
Type : II
Date of Issue : 2022-09-01
Valid Till : 2024-11-05
Written Confirmation Number : WC-0297
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-05
Pay. Date : 2013-01-28
DMF Number : 2726
Submission : 1976-08-05
Status : Active
Type : II
Certificate Number : CEP 2000-110 - Rev 05
Issue Date : 2023-09-12
Type : Chemical
Substance Number : 234
Status : Valid
NDC Package Code : 12866-1013
Start Marketing Date : 2017-05-13
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 : 22505
Submission : 2009-02-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6639
Submission : 1986-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2010
Submission : 1972-10-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2983
Submission : 1977-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24176
Submission : 2010-10-06
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-158 - Rev 00
Issue Date : 2016-08-26
Type : Chemical
Substance Number : 234
Status : Valid
Registration Number : 228MF10157
Registrant's Address : No. 1 Junye Road, Xianju, Taizhou, Zhejiang, China
Initial Date of Registration : 2016-08-10
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2046
Submission : 1973-02-08
Status : Inactive
Type : II
Certificate Number : CEP 2023-427 - Rev 00
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 234
Status : Valid
Registration Number : 219MF10281
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2007-09-10
Latest Date of Registration : --
NDC Package Code : 12866-1013
Start Marketing Date : 2017-05-13
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 : 3353
Submission : 1978-11-10
Status : Inactive
Type : II
Date of Issue : 2020-09-08
Valid Till : 2023-04-24
Written Confirmation Number : WC-0402A2
Address of the Firm :
Date of Issue : 2018-11-05
Valid Till : 2021-11-04
Written Confirmation Number : WC-297
Address of the Firm :
Certificate Number : R0-CEP 2022-141 - Rev 00
Issue Date : 2022-07-29
Type : Chemical
Substance Number : 234
Status : Valid
Certificate Number : R1-CEP 2013-050 - Rev 00
Issue Date : 2018-07-23
Type : Chemical
Substance Number : 234
Status : Valid
NDC Package Code : 12866-1013
Start Marketing Date : 2017-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2010-369 - Rev 00
Issue Date : 2017-03-17
Type : Chemical
Substance Number : 234
Status : Withdrawn by Holder
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 : 2068
Submission : 1973-01-29
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 : 7588
Submission : 1988-07-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A 17.alpha.-Ethynyl-19-nortestosterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 17.alpha.-Ethynyl-19-nortestosterone, including repackagers and relabelers. The FDA regulates 17.alpha.-Ethynyl-19-nortestosterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 17.alpha.-Ethynyl-19-nortestosterone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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