Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
01 1Pfizer CentreOne
02 2Axplora
03 1Hubei Gedian Humanwell Pharmaceutical
04 1ACS DOBFAR SPA
05 1Amphastar Pharmaceuticals
06 1Bayer AG
07 1Curia
08 1GD Searle LLC
09 1Merck & Co
10 1Pfizer Inc
11 1SIMS Srl
12 1TAPI Technology & API Services
13 1Taizhou Taifa Pharmaceuticals Co. Ltd.
14 1YANCHENG XINYI PHARM AND CHEM CO LTD
15 1Zhejiang Xianju Pharmaceutical Co. Ltd
16 1Zhejiang Xianju Yangguang Bioproducts
17 1Blank
01 8MEDROXYPROGESTERONE ACETATE
02 1MEDROXYPROGESTERONE ACETATE (NON-STERILE BULK FORM)
03 1MEDROXYPROGESTERONE ACETATE MICRO
04 1MEDROXYPROGESTERONE ACETATE STERILE MICRONIZED
05 1MEDROXYPROGESTERONE ACETATE USP KALAMAZOO
06 1MEDROXYPROGESTERONE ACETATE USP, NON-STERILE BULK DRUG SUBSTANCE
07 1MEDROXYPROGESTERONE ACETATE, USP
08 1MEDROXYPROGESTERONE ACETATE,BULK
09 1NORTHINDQONE, MESTRANOL, MEDROXYPROGESTERONE
10 1PROMONE (MEDROXYPROGESTERONE ACETATE (VET)
11 1STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED)
01 5China
02 3Germany
03 1Israel
04 2Italy
05 6U.S.A
06 1Blank
01 11Active
02 7Inactive
01 4Complete
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4975
Submission : 1983-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12695
Submission : 1997-10-15
Status : Active
Type : II
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27995
Submission : 2014-02-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2014-09-03
DMF Number : 26389
Submission : 2012-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-14
Pay. Date : 2021-09-30
DMF Number : 32282
Submission : 2018-02-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5389
Submission : 1984-05-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-12-22
DMF Number : 28800
Submission : 2014-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27546
Submission : 2014-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12703
Submission : 1997-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-09
Pay. Date : 2013-09-25
DMF Number : 19433
Submission : 2006-05-10
Status : Active
Type : II
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