Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1Coral Drugs Private Limited
02 1Axplora
03 1LGM Pharma
04 1Symbiotec Pharmalab
05 1Hubei Gedian Humanwell Pharmaceutical
06 1AASraw Biochemical Technology Co., Ltd
07 1Apotex Pharmachem
08 1Cipla
09 1Curia
10 1Guangzhou Tosun Pharmaceutical
11 1Mac-Chem Products (India) Pvt.Ltd
12 1Perrigo API India Private Limited
13 1Pfizer Inc
14 2Qilu Pharmaceutical
15 1Sakar Healthcare
16 1ScinoPharm Taiwan, Ltd
17 1Shandong Anhong Pharmaceutical
18 2Sterling Spa
19 1Sun Pharmaceutical Industries Limited
20 1Symbiotica Specialty Ingredients
21 1Synthon Pharmaceuticals
22 1Trifarma
23 1Unipex
24 1YANCHENG XINYI PHARM AND CHEM CO LTD
25 2Zydus Lifesciences
01 1Canada
02 7China
03 1France
04 1Germany
05 9India
06 3Italy
07 1Malaysia
08 1Netherlands
09 1Taiwan
10 3U.S.A
01 10Active
02 7Inactive
03 11Blank
01 9Valid
02 1Withdrawn by Holder
03 18Blank
01 1222MF10188
02 27Blank
01 1WC-0009
02 1WC-0140
03 1WC-0162
04 1WC-0168
05 24Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38247
Submission : 2023-03-29
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-11-14
DMF Number : 26291
Submission : 2012-07-26
Status : Active
Type : II
Certificate Number : R0-CEP 2018-274 - Rev 00
Issue Date : 2020-12-18
Type : Chemical
Substance Number : 2766
Status : Valid
NDC Package Code : 46439-8746
Start Marketing Date : 2012-07-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-04
Pay. Date : 2014-10-20
DMF Number : 22439
Submission : 2009-01-21
Status : Active
Type : II
Certificate Number : R1-CEP 2017-056 - Rev 00
Issue Date : 2023-03-17
Type : Chemical
Substance Number : 2766
Status : Valid
NDC Package Code : 64918-0621
Start Marketing Date : 2014-07-24
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 : 25275
Submission : 2011-07-25
Status : Active
Type : II
Certificate Number : R1-CEP 2016-116 - Rev 00
Issue Date : 2023-08-01
Type : Chemical
Substance Number : 2766
Status : Valid
NDC Package Code : 52128-134
Start Marketing Date : 2006-04-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-23
Pay. Date : 2015-01-02
DMF Number : 28960
Submission : 2015-03-02
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21441
Submission : 2007-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22365
Submission : 2008-12-29
Status : Inactive
Type : II
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