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JDMF
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API SUPPLIERS
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USDMF
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 : 40164
Submission : 2024-06-27
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-04-15
Pay. Date : 2025-03-11
DMF Number : 36647
Submission : 2021-12-30
Status :
Type : II
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Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
N-(5- (Phenylamino)- 2,4 -Pentadienylidene) Anilin...
CAS Number : 1497-49-0
End Use API : Indocyanine Green
About The Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty F...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
4-(1,1,2-Trimethyl-1H-Benzo[E]Indol-3-Ium-3-Yl)But...
CAS Number : 63149-24-6
End Use API : Indocyanine Green
About The Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty F...
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PharmaCompass offers a list of Indocyanine Green 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 Indocyanine Green manufacturer or Indocyanine Green supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indocyanine Green manufacturer or Indocyanine Green supplier.
PharmaCompass also assists you with knowing the Indocyanine Green API Price utilized in the formulation of products. Indocyanine Green API Price is not always fixed or binding as the Indocyanine Green Price is obtained through a variety of data sources. The Indocyanine Green Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Indocyanine Green manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indocyanine Green, including repackagers and relabelers. The FDA regulates Indocyanine Green manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indocyanine Green API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Indocyanine Green manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indocyanine Green supplier is an individual or a company that provides Indocyanine Green active pharmaceutical ingredient (API) or Indocyanine Green finished formulations upon request. The Indocyanine Green suppliers may include Indocyanine Green API manufacturers, exporters, distributors and traders.
click here to find a list of Indocyanine Green suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indocyanine Green DMF (Drug Master File) is a document detailing the whole manufacturing process of Indocyanine Green active pharmaceutical ingredient (API) in detail. Different forms of Indocyanine Green DMFs exist exist since differing nations have different regulations, such as Indocyanine Green USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indocyanine Green DMF submitted to regulatory agencies in the US is known as a USDMF. Indocyanine Green USDMF includes data on Indocyanine Green's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indocyanine Green USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indocyanine Green suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Indocyanine Green Drug Master File in Korea (Indocyanine Green KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indocyanine Green. The MFDS reviews the Indocyanine Green KDMF as part of the drug registration process and uses the information provided in the Indocyanine Green KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indocyanine Green KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Indocyanine Green API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Indocyanine Green suppliers with KDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Indocyanine Green as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Indocyanine Green API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Indocyanine Green as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Indocyanine Green and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Indocyanine Green NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Indocyanine Green suppliers with NDC on PharmaCompass.
Indocyanine Green Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Indocyanine Green GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Indocyanine Green GMP manufacturer or Indocyanine Green GMP API supplier for your needs.
A Indocyanine Green CoA (Certificate of Analysis) is a formal document that attests to Indocyanine Green's compliance with Indocyanine Green specifications and serves as a tool for batch-level quality control.
Indocyanine Green CoA mostly includes findings from lab analyses of a specific batch. For each Indocyanine Green CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Indocyanine Green may be tested according to a variety of international standards, such as European Pharmacopoeia (Indocyanine Green EP), Indocyanine Green JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Indocyanine Green USP).
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