Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 2Macsen Labs
04 1ChemCon GmbH
05 1ISO TEX DIAGNOSTICS INC
06 1Icrom
07 1Luitpold Pharmaceuticals, Inc.
08 1Mikrochem
09 1Provepharm Life Solutions
10 1Sichuan Qingmu Pharmaceutical
01 5METHYLENE BLUE
02 1METHYLENE BLUE I-125
03 1METHYLENE BLUE INJECTION, USP 1%
04 3METHYLENE BLUE USP
05 1METHYLENE BLUE USP (COLOUR)
01 1China
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07 3U.S.A
01 9Active
02 2Inactive
01 7Complete
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GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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DMF Review : Complete
Rev. Date : 2022-06-28
Pay. Date : 2022-05-10
DMF Number : 36603
Submission : 2022-06-01
Status : Active
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-08-28
DMF Number : 35095
Submission : 2020-08-17
Status : Active
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
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DMF Number : 35482
Submission : 2020-12-22
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-07-01
DMF Number : 36353
Submission : 2022-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-25
Pay. Date : 2021-12-16
DMF Number : 36307
Submission : 2021-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 15237
Submission : 2000-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-23
Pay. Date : 2023-02-21
DMF Number : 31694
Submission : 2017-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 26735
Submission : 2013-01-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-01
Pay. Date : 2024-04-19
DMF Number : 39341
Submission : 2024-04-15
Status : Active
Type : II
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