Synopsis
0
CEP/COS
0
VMF
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
10
PharmaCompass offers a list of Indigo Carmine 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 Indigo Carmine manufacturer or Indigo Carmine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indigo Carmine manufacturer or Indigo Carmine supplier.
PharmaCompass also assists you with knowing the Indigo Carmine API Price utilized in the formulation of products. Indigo Carmine API Price is not always fixed or binding as the Indigo Carmine Price is obtained through a variety of data sources. The Indigo Carmine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Indigo-karmin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indigo-karmin, including repackagers and relabelers. The FDA regulates Indigo-karmin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indigo-karmin 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 Indigo-karmin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indigo-karmin supplier is an individual or a company that provides Indigo-karmin active pharmaceutical ingredient (API) or Indigo-karmin finished formulations upon request. The Indigo-karmin suppliers may include Indigo-karmin API manufacturers, exporters, distributors and traders.
click here to find a list of Indigo-karmin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indigo-karmin DMF (Drug Master File) is a document detailing the whole manufacturing process of Indigo-karmin active pharmaceutical ingredient (API) in detail. Different forms of Indigo-karmin DMFs exist exist since differing nations have different regulations, such as Indigo-karmin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indigo-karmin DMF submitted to regulatory agencies in the US is known as a USDMF. Indigo-karmin USDMF includes data on Indigo-karmin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indigo-karmin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indigo-karmin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Indigo-karmin Drug Master File in Japan (Indigo-karmin JDMF) empowers Indigo-karmin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Indigo-karmin JDMF during the approval evaluation for pharmaceutical products. At the time of Indigo-karmin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Indigo-karmin suppliers with JDMF 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 Indigo-karmin Drug Master File in Korea (Indigo-karmin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indigo-karmin. The MFDS reviews the Indigo-karmin KDMF as part of the drug registration process and uses the information provided in the Indigo-karmin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indigo-karmin 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 Indigo-karmin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Indigo-karmin suppliers with KDMF on PharmaCompass.
A Indigo-karmin written confirmation (Indigo-karmin WC) is an official document issued by a regulatory agency to a Indigo-karmin manufacturer, verifying that the manufacturing facility of a Indigo-karmin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Indigo-karmin APIs or Indigo-karmin finished pharmaceutical products to another nation, regulatory agencies frequently require a Indigo-karmin WC (written confirmation) as part of the regulatory process.
click here to find a list of Indigo-karmin suppliers with Written Confirmation (WC) 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 Indigo-karmin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Indigo-karmin 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 Indigo-karmin 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 Indigo-karmin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Indigo-karmin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Indigo-karmin suppliers with NDC on PharmaCompass.
Indigo-karmin 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 Indigo-karmin 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 Indigo-karmin GMP manufacturer or Indigo-karmin GMP API supplier for your needs.
A Indigo-karmin CoA (Certificate of Analysis) is a formal document that attests to Indigo-karmin's compliance with Indigo-karmin specifications and serves as a tool for batch-level quality control.
Indigo-karmin CoA mostly includes findings from lab analyses of a specific batch. For each Indigo-karmin 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.
Indigo-karmin may be tested according to a variety of international standards, such as European Pharmacopoeia (Indigo-karmin EP), Indigo-karmin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Indigo-karmin USP).
