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01 1Ami Lifesciences Private Limited
02 1Macsen Labs
03 1Albemarle Corporation
04 1Aspire Lifesciences Pvt Ltd
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06 1Formosa Laboratories
07 1Grace
08 1KINGLAND CHEMICALS CO LTD
09 1Novartis Pharmaceuticals Corporation
10 1Siegfried AG
01 1China
02 3India
03 2Switzerland
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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 : 24194
Submission : 2010-09-20
Status : Inactive
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
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