Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
01 2Pfizer CentreOne
02 1Coral Drugs Private Limited
03 2Axplora
04 1LGM Pharma
05 1Symbiotec Pharmalab
06 1Hubei Gedian Humanwell Pharmaceutical
07 1TAPI Technology & API Services
08 1Bayer AG
09 2Fujifilm Diosynth Biotechnologies
10 1GSK
11 1Hanways Chempharm
12 1JIANGSU GRAND XIANLE PHARMACEUTICAL CO LTD
13 1Merck & Co
14 1Pfizer Inc
15 1SIMS Srl
16 1Taizhou Taifa Pharmaceuticals Co. Ltd.
17 1Teva Pharmaceutical Industries
18 1Zhejiang Xianju Pharmaceutical Co. Ltd
19 1Zhejiang Xianju Yangguang Bioproducts
20 1Blank
01 6China
02 3Germany
03 2India
04 2Israel
05 1Italy
06 5U.S.A
07 3United Kingdom
08 1Blank
01 7Active
02 7Inactive
03 9Blank
01 8Valid
02 15Blank
01 23Blank
01 23Blank
Certificate Number : R1-CEP 2006-230 - Rev 01
Issue Date : 2014-04-23
Type : Chemical
Substance Number : 1593
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-25
Pay. Date : 2021-03-22
DMF Number : 12662
Submission : 1997-09-20
Status : Active
Type : II
Certificate Number : R1-CEP 2002-154 - Rev 05
Issue Date : 2019-02-11
Type : Chemical
Substance Number : 1593
Status : Valid
NDC Package Code : 46439-8722
Start Marketing Date : 1998-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : 20210409-211-J-738
Manufacturer Name : Farmabios SpA@Micro-Macinazione SA@IMS srl@Micro-Macinazione SA
Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli (PV), Italy@Zona Artigianale 11, 6995 Madonna del Piano, Switzerland@Via Venezia Giulia 23, 20157 Milano@Via Cantonale 4, 6998 Monteggio, Switzerland
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 12687
Submission : 1997-10-08
Status : Active
Type : II
Available Reg Filing : ASMF |
Certificate Number : R1-CEP 2008-020 - Rev 01
Issue Date : 2014-09-04
Type : Chemical
Substance Number : 1593
Status : Valid
Certificate Number : CEP 2002-181 - Rev 09
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 1593
Status : Valid
NDC Package Code : 46439-8722
Start Marketing Date : 1998-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-04-09
Registration Number : 20210409-211-J-738
Manufacturer Name : Farmabios SpA@Micro-Macinazione SA@IMS srl@Micro-Macinazione SA
Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli (PV), Italy@Zona Artigianale 11, 6995 Madonna del Piano, Switzerland@Via Venezia Giulia 23, 20157 Milano@Via Cantonale 4, 6998 Monteggio, Switzerland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3869
Submission : 1980-06-13
Status : Inactive
Type : II
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