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01 1Ami Lifesciences Private Limited
02 1Macsen Labs
03 1Albemarle Corporation
04 1Aspire Lifesciences Pvt Ltd
05 1Catalent Pharma Solutions
06 1Formosa Laboratories
07 1Grace
08 1KINGLAND CHEMICALS CO LTD
09 1Novartis Pharmaceuticals Corporation
10 1Siegfried AG
01 1China
02 3India
03 2Switzerland
04 1Taiwan
05 3U.S.A
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02 3Inactive
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01 1WC-0054
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39002
Submission : 2023-12-04
Status : Active
Type : II
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-03
Pay. Date : 2013-05-03
DMF Number : 21703
Submission : 2008-06-16
Status : Active
Type : II
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-05-03
Registration Number : 20220503-209-J-1282
Manufacturer Name : Formosa Laboratories, Inc.
Manufacturer Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-06
Pay. Date : 2013-05-23
DMF Number : 5196
Submission : 1983-12-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 7843
Submission : 1988-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12327
Submission : 1997-01-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12421
Submission : 1997-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24194
Submission : 2010-09-20
Status : Inactive
Type : II
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