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01 2Fermion Oy
02 1Pfanstiehl
03 1CF Pharma
04 1Sichuan Elixir Pharmaceuticals
05 1Alembic Pharmaceuticals Limited
06 1BEDFORD LABS
07 1Benzo Chem Industries Pvt. Ltd.
08 2Fareva
09 1Huzhou Zhanwang Pharmaceutical Co.,Ltd.
10 1LIANYUNGANG GUIKE PHARMACEUTICAL
11 1Mitsubishi Corporation
12 1SEACROSS PHARMACEUTICALS
13 1SIGMA TAU
14 1Zhejiang Hisun Pharmaceutical
15 5Blank
01 1AMETHOPTERIN (METHOTREXATE)
02 1DISODIUM METHOTREXATE
03 1FACILS & CONTROLS FOR LEDERLE METHOTREXATE, INC. & LEDERLE PARENTERALS
04 8METHOTREXATE
05 1METHOTREXATE DISODIUM
06 3METHOTREXATE SODIUM
07 1METHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED
08 3METHOTREXATE USP
09 1METHOTREXATE USP, NON-STERILE BULK DRUG
10 1METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1)
01 4China
02 2Finland
03 1Hungary
04 2India
05 1Japan
06 2Luxembourg
07 3U.S.A
08 1United Kingdom
09 5Blank
01 11Active
02 10Inactive
01 6Complete
02 15Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-08
Pay. Date : 2013-05-23
DMF Number : 4246
Submission : 1981-08-06
Status : Active
Type : II
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39988
Submission : 2024-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25957
Submission : 2012-04-10
Status : Active
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39758
Submission : 2024-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2014-04-17
DMF Number : 23532
Submission : 2010-01-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-22
Pay. Date : 2021-09-20
DMF Number : 36277
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 11704
Submission : 1995-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-26
Pay. Date : 2018-11-16
DMF Number : 12472
Submission : 1997-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20255
Submission : 2007-01-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-15
DMF Number : 21118
Submission : 2007-11-30
Status : Active
Type : II
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