Axplora is your partner of choice for complex APIs.
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01 1Axplora
02 1ChemWerth Inc
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 2Macsen Labs
07 1Aktinos
08 1Apicore
09 1Azico Biophore India Pvt. Ltd
10 1BD RX INC
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01 112598-9541
02 117223-0030
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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 : 73379-102
Start Marketing Date : 2023-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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 : 2025-12-31
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
NDC Package Code : 82712-1005
Start Marketing Date : 2025-02-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (2.5kg/2.5kg)
Marketing Category : BULK INGREDIENT
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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PharmaCompass offers a list of Methylene Blue API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Methylene Blue manufacturer or Methylene Blue supplier for your needs.
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A azul de metileno manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of azul de metileno, including repackagers and relabelers. The FDA regulates azul de metileno manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. azul de metileno API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A azul de metileno supplier is an individual or a company that provides azul de metileno active pharmaceutical ingredient (API) or azul de metileno finished formulations upon request. The azul de metileno suppliers may include azul de metileno API manufacturers, exporters, distributors and traders.
click here to find a list of azul de metileno suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 30 companies offering azul de metileno
Get in contact with the supplier of your choice: