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 1Octavius Pharma Pvt. Ltd
10 1ACS DOBFAR SPA
11 1Anuh Pharma LTD
12 1Arudavis Labs
13 2Avik Pharmaceutical Limited
14 1Balaji Corporation
15 1Cerata Pharmaceuticals
16 3Curia
17 2Cyclo Industries
18 2Fujifilm Diosynth Biotechnologies
19 1Grefuel
20 1Hameln rds
21 1Hengdian Group
22 1Jiangsu Lianhuan Pharmaceutical
23 1Jin Dun Medical
24 1Maharshi Pharma Chem
25 1Mahima Life Sciences
26 5Merck & Co
27 3NEWCHEM SPA
28 1Pfizer Inc
29 1Quimica Sintetica
30 1SIMS Srl
31 3SM BIOMED
32 1Shandong Sito Bio-technology Co ltd
33 1Sicor de Mexico
34 2Steroid SpA
35 1Symbiotica Specialty Ingredients
36 1Teva API
37 1Teva Pharmaceutical Industries
38 3Tianjin Tianyao Pharmaceuticals Co., Ltd.
39 2Unipex
40 1Xi'an Guokang Ruijin Pharmaceutical
41 2Xian Ascend Biotech Co.,Ltd
42 2Xian Reyphon Pharmaceutical Co., Ltd
43 1Yangzhou Pharmaceutical
44 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
45 2Zhejiang Xianju Pharmaceutical Co. Ltd
46 1Blank
01 16China
02 4France
03 1Germany
04 15India
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 47Blank
01 2Expired
02 7Valid
03 64Blank
01 1217MF11173
02 1218MF10376
03 1218MF10748
04 1218MF10901
05 1221MF10091
06 1227MF10063
07 67Blank
01 1WC-0161A2
02 1WC-0162
03 71Blank
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.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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 |
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