EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 2EUROAPI
02 5Pfizer CentreOne
03 2Symbiotec Pharmalab
04 1Axplora
05 1LGM Pharma
06 1DKSH
07 2Gonane Pharma
08 1Vamsi Labs
09 1ACS DOBFAR SPA
10 1Anuh Pharma LTD
11 1Arudavis Labs
12 2Avik Pharmaceutical Limited
13 1Balaji Corporation
14 1Cerata Pharmaceuticals
15 3Curia
16 2Cyclo Industries
17 2Fujifilm Diosynth Biotechnologies
18 1Grefuel
19 1Hameln rds
20 1Hengdian Group
21 1Jiangsu Lianhuan Pharmaceutical
22 1Jin Dun Medical
23 1Maharshi Pharma Chem
24 1Mahima Life Sciences
25 5Merck & Co
26 3NEWCHEM SPA
27 1Pfizer Inc
28 1Quimica Sintetica
29 1SIMS Srl
30 3SM BIOMED
31 1Shandong Sito Bio-technology Co ltd
32 1Sicor de Mexico
33 2Steroid SpA
34 1Symbiotica Specialty Ingredients
35 1Teva API
36 1Teva Pharmaceutical Industries
37 3Tianjin Tianyao Pharmaceuticals Co., Ltd.
38 2Unipex
39 1Xi'an Guokang Ruijin Pharmaceutical
40 2Xian Ascend Biotech Co.,Ltd
41 2Xian Reyphon Pharmaceutical Co., Ltd
42 1Yangzhou Pharmaceutical
43 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
44 2Zhejiang Xianju Pharmaceutical Co. Ltd
45 1Blank
01 16China
02 4France
03 1Germany
04 14India
05 2Israel
06 7Italy
07 4Malaysia
08 1Mexico
09 1Slovakia
10 1Spain
11 1Switzerland
12 17U.S.A
13 2United Kingdom
14 1Blank
01 13Active
02 13Inactive
03 46Blank
01 2Expired
02 7Valid
03 63Blank
01 1217MF11173
02 1218MF10376
03 1218MF10748
04 1218MF10901
05 1221MF10091
06 1227MF10063
07 66Blank
01 1WC-0161A2
02 1WC-0162
03 70Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-28
Pay. Date : 2013-09-18
DMF Number : 1748
Submission : 1971-06-21
Status : Active
Type : II
Certificate Number : R1-CEP 1998-089 - Rev 07
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 548
Status : Valid
Registration Number : 218MF10376
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2006-03-20
Latest Date of Registration : --
NDC Package Code : 82298-110
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2023-07-03
Registration Number : 20230405-209-J-1469(A)
Manufacturer Name : EUROAPI France
Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France
VMF Number : 5622
Submission : 1998-02-02
Status : Inactive
Type : II
Available Reg Filing : IN, ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 4524
Submission : 1982-05-10
Status : Active
Type : II
Certificate Number : R1-CEP 2000-261 - Rev 05
Issue Date : 2022-09-02
Type : Chemical
Substance Number : 388
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-26
Pay. Date : 2023-10-03
DMF Number : 38162
Submission : 2023-03-29
Status : Active
Type : II
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0039
Start Marketing Date : 2014-08-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-09
Pay. Date : 2018-03-15
DMF Number : 31532
Submission : 2017-03-10
Status : Active
Type : II
NDC Package Code : 46439-8765
Start Marketing Date : 2018-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2736
Submission : 1976-07-19
Status : Active
Type : II
Certificate Number : CEP 1996-019 - Rev 09
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 388
Status : Valid
NDC Package Code : 82298-110
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2023-07-03
Registration Number : 20230405-209-J-1469(A)
Manufacturer Name : EUROAPI France
Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France
VMF Number : 5622
Submission : 1998-02-02
Status : Inactive
Type : II
Available Reg Filing : IN, ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4532
Submission : 1982-05-10
Status : Active
Type : II
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