Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 2Macsen Labs
07 1BD RX INC
08 1Bioindustria L.I.M. Spa
09 1ChemCon GmbH
10 1Dishman Carbogen Amcis
11 1Hetero Drugs
12 1ISO TEX DIAGNOSTICS INC
13 1Icrom
14 1Luitpold Pharmaceuticals, Inc.
15 1Mikrochem
16 1Provepharm Life Solutions
17 1Sichuan Qingmu Pharmaceutical
01 1China
02 1France
03 2Germany
04 7India
05 2Italy
06 1Slovakia
07 4U.S.A
01 9Active
02 2Inactive
03 7Blank
01 3Valid
02 15Blank
01 18Blank
01 1WC-0019
02 1WC-0438
03 16Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status : Active
Type : II
Certificate Number : CEP 2023-129 - Rev 00
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 1132
Status : Valid
Date of Issue : 2022-03-18
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019
Address of the Firm :
NDC Package Code : 12598-9541
Start Marketing Date : 2018-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : EU |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-28
Pay. Date : 2022-05-10
DMF Number : 36603
Submission : 2022-06-01
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-18
Pay. Date : 2023-08-28
DMF Number : 35095
Submission : 2020-08-17
Status : Active
Type : II
Date of Issue : 2022-03-28
Valid Till : 2025-02-17
Written Confirmation Number : WC-0438
Address of the Firm :
NDC Package Code : 73379-101
Start Marketing Date : 2020-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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 : Active
Type : IV
NDC Package Code : 73379-101
Start Marketing Date : 2020-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-05-01
Pay. Date : 2024-04-19
DMF Number : 39341
Submission : 2024-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26735
Submission : 2013-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17684
Submission : 2004-09-09
Status : Inactive
Type : II
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