LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Ahk Tech
03 1Apotex Pharmachem
04 2Archimica
05 1Asahi Kasei Finechem
06 1Axitec
07 1Beijing Mesochem Technology
08 1Biesterfeld Spezialchemie GmbH
09 1Fujian South Pharmaceutical
10 1Guangzhou Tosun Pharmaceutical
11 1Kekule Pharma
12 1Linnea SA
13 1Mac-Chem Products (India) Pvt.Ltd
14 1Pfizer Inc
15 1Roche Diagnostics GmbH
16 1Sakar Healthcare
17 1Shenzhen Haorui
18 1Shouyuan Chemical
19 1Surajlok Chemicals
20 1Tecoland Corporation
21 1Vannsh Life Sciences
22 1Yamasa Corporation
23 1Zhejiang Hisun Pharmaceutical
24 5Blank
01 1Canada
02 8China
03 2Germany
04 5India
05 2Italy
06 2Japan
07 1Switzerland
08 3U.S.A
09 5Blank
01 4Active
02 11Inactive
03 14Blank
01 4Valid
02 1Withdrawn by Holder
03 24Blank
01 1217MF10811
02 1218MF10475
03 27Blank
01 1WC-0275
02 1WC-0435
03 27Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
Certificate Number : CEP 2023-289 - Rev 00
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 760
Status : Valid
NDC Package Code : 55512-0026
Start Marketing Date : 2019-12-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-30
Pay. Date : 2017-06-08
DMF Number : 6215
Submission : 1986-01-23
Status : Active
Type : II
Certificate Number : CEP 2017-218 - Rev 03
Issue Date : 2024-09-20
Type : Chemical
Substance Number : 760
Status : Valid
Registration Number : 217MF10811
Registrant's Address : 3-3-23 Nakanoshima, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : --
NDC Package Code : 12848-1003
Start Marketing Date : 1986-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Handok Co., Ltd.
Registration Date : 2022-07-13
Registration Number : 20220713-210-J-1332
Manufacturer Name : Asahi Kasei Finechem Co., Ltd. Nobeoka Pharmaceuticals Plant
Manufacturer Address : 6-2633-7 Asahimachi, Nobeoka, Miyazaki 882-0847, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26281
Submission : 2012-05-24
Status : Active
Type : II
Certificate Number : CEP 2012-251 - Rev 02
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 760
Status : Valid
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 15959
Submission : 2002-04-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-390 - Rev 03
Issue Date : 2016-08-02
Type : Chemical
Substance Number : 760
Status : Withdrawn by Holder
NDC Package Code : 58623-0026
Start Marketing Date : 2004-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1534
Submission : 1970-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9468
Submission : 1991-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7770
Submission : 1988-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23469
Submission : 2010-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18071
Submission : 2005-01-21
Status : Inactive
Type : II
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