HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1ALPS Pharmaceutical Ind. Co. Ltd.
03 1Amphastar Pharmaceuticals
04 1Biochem Corporation JP 350-0814 Saitama
05 1GLAND PHARMA LIMITED
06 1Reliable Biopharmaceutical Corporation
07 1Sichuan Xieli Pharmaceutical
08 2Yuki Gosei Kogyo
01 1China
02 2India
03 4Japan
04 2U.S.A
01 4Active
02 3Inactive
03 2Blank
01 1Withdrawn by EDQM Failure to CEP procedure
02 8Blank
01 1221MF10290
02 8Blank
01 9Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-11-28
DMF Number : 15421
Submission : 2000-01-25
Status : Active
Type : II
NDC Package Code : 12785-0779
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-23
Pay. Date : 2021-12-14
DMF Number : 36568
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-19
Pay. Date : 2022-10-11
DMF Number : 30429
Submission : 2016-09-16
Status : Active
Type : II
NDC Package Code : 52221-110
Start Marketing Date : 2015-07-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-18
Pay. Date : 2018-09-27
DMF Number : 20538
Submission : 2007-05-11
Status : Active
Type : II
NDC Package Code : 17353-0123
Start Marketing Date : 2011-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4626
Submission : 1982-07-30
Status : Inactive
Type : II
Registration Number : 221MF10290
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2009-12-25
Latest Date of Registration : --
NDC Package Code : 12785-0779
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14973
Submission : 2000-07-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-162 - Rev 00
Issue Date : 2010-09-14
Type : Chemical
Substance Number : 569
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19008
Submission : 2005-12-02
Status : Inactive
Type : II
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