Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1Coral Drugs Private Limited
02 1Fermion Oy
03 1Arevipharma
04 2Cipla
05 1Curia
06 1Derivados Quimicos SAU
07 1Gedeon Richter
08 1Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. CN 223 002 Huai'an
09 1Olon S.p.A
10 1Unichem Laboratories Limited
11 3Blank
01 1China
02 1Finland
03 1Germany
04 1Hungary
05 4India
06 1Italy
07 1Spain
08 1U.S.A
09 3Blank
01 2Active
02 7Inactive
03 5Blank
01 4Valid
02 3Withdrawn by Holder
03 7Blank
01 1217MF11174
02 13Blank
01 1WC-0009
02 1WC-0113
03 1WC-0138
04 11Blank
Certificate Number : CEP 2001-416 - Rev 04
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 1423
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11522
Submission : 1995-05-23
Status : Active
Type : II
Certificate Number : R1-CEP 2002-134 - Rev 03
Issue Date : 2019-11-18
Type : Chemical
Substance Number : 1423
Status : Valid
NDC Package Code : 12780-4750
Start Marketing Date : 1995-05-23
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 : 12807
Submission : 1997-12-17
Status : Active
Type : II
Certificate Number : CEP 2000-049 - Rev 07
Issue Date : 2024-09-10
Type : Chemical
Substance Number : 1423
Status : Valid
NDC Package Code : 44657-0048
Start Marketing Date : 2012-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10497
Submission : 1993-09-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-282 - Rev 01
Issue Date : 2011-12-15
Type : Chemical
Substance Number : 1423
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23507
Submission : 2010-01-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-297 - Rev 01
Issue Date : 2014-02-06
Type : Chemical
Substance Number : 1423
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19951
Submission : 2006-11-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14637
Submission : 1999-12-20
Status : Inactive
Type : II
Date of Issue : 2022-06-20
Valid Till : 2025-08-08
Written Confirmation Number : WC-0113
Address of the Firm :
NDC Package Code : 53104-7536
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
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 : 4144
Submission : 1981-04-16
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 : 12790
Submission : 1997-12-11
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 : 14719
Submission : 2000-02-18
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Odyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odyne, including repackagers and relabelers. The FDA regulates Odyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odyne 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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A Odyne supplier is an individual or a company that provides Odyne active pharmaceutical ingredient (API) or Odyne finished formulations upon request. The Odyne suppliers may include Odyne API manufacturers, exporters, distributors and traders.
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