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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
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-28
Pay. Date : 2022-05-10
DMF Number : 36603
Submission : 2022-06-01
Status :
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 :
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35482
Submission : 2020-12-22
Status :
Type : IV
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