Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1Coral Drugs Private Limited
02 1LGM Pharma
03 1Evonik
04 1Vamsi Labs
05 1Actylis
06 1Cipla
07 1Curia
08 1DAITO CORP
09 1Daito Pharmaceutical
10 1Esteve Quimica
11 1Gedeon Richter
12 1Globofarm International
13 1Guangzhou Tosun Pharmaceutical
14 1Jiangsu Hengrui Medicine
15 1Korea United Pharm. Inc.
16 2MSN Laboratories
17 1Noucor
18 1Unipex
19 1Urquima S.A. Grupo Uriach
20 1Viatris
21 1Yoshindo
22 1Zhejiang Lepu Pharmaceutical
23 1Zydus Lifesciences
01 3China
02 1France
03 1Germany
04 1Hungary
05 7India
06 3Japan
07 1South Korea
08 3Spain
09 4U.S.A
01 11Active
02 3Inactive
03 10Blank
01 6Valid
02 1Withdrawn by Holder
03 17Blank
01 1218MF10125
02 1221MF10060
03 22Blank
01 1WC-0009
02 1WC-0021
03 1WC-0021n
04 1WC-0084
05 20Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-01
Pay. Date : 2023-09-22
DMF Number : 36205
Submission : 2021-10-09
Status : Active
Type : II
Certificate Number : R0-CEP 2021-124 - Rev 00
Issue Date : 2022-08-10
Type : Chemical
Substance Number : 1633
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 : 49076-7601
Start Marketing Date : 2019-06-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15440
Submission : 2001-05-15
Status : Active
Type : II
Certificate Number : CEP 2009-333 - Rev 05
Issue Date : 2024-04-24
Type : Chemical
Substance Number : 1633
Status : Valid
NDC Package Code : 49274-1101
Start Marketing Date : 2001-05-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2008-08-29
Registration Number : 20080829-44-C-224-06
Manufacturer Name : Evonik Operations GmbH
Manufacturer Address : Rodenbacher Chaussee 4 63457 Hanau, Germany
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-25
Pay. Date : 2015-02-18
DMF Number : 15361
Submission : 2001-03-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-20
Pay. Date : 2013-11-14
DMF Number : 22427
Submission : 2009-01-20
Status : Active
Type : II
Certificate Number : R1-CEP 2010-010 - Rev 03
Issue Date : 2020-08-17
Type : Chemical
Substance Number : 1633
Status : Valid
NDC Package Code : 57572-0713
Start Marketing Date : 2007-09-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-10
DMF Number : 20314
Submission : 2007-02-12
Status : Active
Type : II
Certificate Number : R1-CEP 2007-097 - Rev 02
Issue Date : 2021-06-16
Type : Chemical
Substance Number : 1633
Status : Valid
NDC Package Code : 54752-0008
Start Marketing Date : 2000-05-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2017-02-15
Registration Number : 20170215-44-C-359-11
Manufacturer Name : Urquima SA
Manufacturer Address : Arnau de Vilanova, 22-42, 08105 Sant Fost de Campsentelles (Barcelona), Spain
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 18398
Submission : 2005-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24317
Submission : 2010-09-28
Status : Active
Type : II
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2005-09-30
Registration Number : 20050930-44-C-150-04
Manufacturer Name : Korea United Pharmaceuticals
Manufacturer Address : 107 Gongdan-ro, Yeonsu-myeon, Sejong Special Self-Governing City_x000D_
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8368
Submission : 1989-12-19
Status : Inactive
Type : II
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