01 1Archimica
02 2Avanti Polar Lipids, Inc.
03 1Foman Biopharma
04 2Haisheng China
05 1Hunan Warrant Chiral Pharmaceutical
06 2PHOSPHOLIPID GMBH
07 1Wuxi Further Pharmaceutical Co Ltd
08 1Xian Tian Guangyuan Biotech
01 6China
02 2Germany
03 1Italy
04 2U.S.A
01 5Active
02 2Inactive
03 4Blank
01 11Blank
01 11Blank
01 11Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32550
Submission : 2018-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32551
Submission : 2018-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 29128
Submission : 2015-03-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23645
Submission : 2010-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 16614
Submission : 2003-05-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 8817
Submission : 1990-11-06
Status : Inactive
Type : II
GDUFA
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Rev. Date :
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DMF Number : 8691
Submission : 1990-08-03
Status : Inactive
Type : II
NDC Package Code : 55512-0022
Start Marketing Date : 2014-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2015-05-06
Registration Number : 20150506-168-I-448-13
Manufacturer Name : Archimica SpA (formerly Euticals SpA)
Manufacturer Address : Viale Milano, 86-26900 Lodi (LO), Italy
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-168-I-634-34
Manufacturer Name : Hunan Warrant Chiral Pharmaceutical Co., Ltd.
Manufacturer Address : No.139, Tongguan Avenue, Tongguan Circular Economy Industrial Park, Wangcheng District, Changsha, Hunan, China
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