Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
01 1Fishfa Biogenics
02 1ChemWerth Inc
03 1AbbVie Inc
04 1Shanghai Minbiotech
05 1Actavis Inc
06 1Apotex Fermentation Inc.
07 1Apotex Pharmachem
08 1CKD Bio Corporation
09 2Catalent Pharma Solutions
10 1Concord Biotech
11 2Curia
12 1Fujian Kerui Pharmaceutical Co Ltd
13 1GALENA AS
14 1Guangzhou Topwork Chemical
15 1Guangzhou Tosun Pharmaceutical
16 1Hangzhou Longshine Bio-Tech
17 1Hangzhou Zhongmei Huadong Pharmaceutical
18 1JOYANG LABORATORIES
19 2North China Pharmaceutical Co., Ltd.
20 1North China Pharmaceutical Huasheng Co Ltd
21 1Novartis Pharmaceuticals Corporation
22 1Ruibang Laboratories
23 1Sandoz B2B
24 1TAISHAN CITY CHEMICAL PHARMACEUTICAL CO., LTD. CN 529 200
25 1Tecoland Corporation
26 4Teva API
27 1Teva Pharmaceutical Industries
28 1Unipex
29 2Zhejiang Ruibang Laboratories
01 2Canada
02 14China
03 1Czech Republic
04 1France
05 2India
06 1Ireland
07 5Israel
08 1South Korea
09 2Switzerland
10 7U.S.A
01 14Active
02 9Inactive
03 13Blank
01 8Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 25Blank
01 1217MF11017
02 1218MF10617
03 1220MF10190
04 1222MF10083
05 1226MF10056
06 1302MF10130
07 1305MF10032
08 1305MF10106
09 1305MF10110
10 27Blank
01 1WC-0111
02 35Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1998-093 - Rev 07
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 0074-5503
Start Marketing Date : 2010-05-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2005-08-31
Registration Number : 20050831-18-C-100-05
Manufacturer Name : AbbVie Inc.
Manufacturer Address : 1401 Sheridan Road, North Chicago, IL, 60064-4000, USA
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33946
Submission : 2019-06-15
Status : Active
Type : II
Registration Number : 305MF10032
Registrant's Address : No. 8 Yangzi Road, Shijiazhuang, Economic & Technical Development Zone, Hebei 052160, China
Initial Date of Registration : 2023-03-07
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-23
Pay. Date : 2015-01-07
DMF Number : 28512
Submission : 2014-12-03
Status : Active
Type : II
Certificate Number : R0-CEP 2020-144 - Rev 00
Issue Date : 2023-04-20
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 66507-0001
Start Marketing Date : 2014-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10281
Submission : 1993-06-08
Status : Inactive
Type : II
Certificate Number : CEP 2021-399 - Rev 00
Issue Date : 2024-02-20
Type : Chemical
Substance Number : 994
Status : Valid
NDC Package Code : 55500-0009
Start Marketing Date : 2019-06-28
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 : 13858
Submission : 1998-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31465
Submission : 2018-03-05
Status : Inactive
Type : II
NDC Package Code : 66507-0001
Start Marketing Date : 2014-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11971
Submission : 1996-05-13
Status : Inactive
Type : II
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