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PharmaCompass offers a list of Ingenol Mebutate 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 Ingenol Mebutate manufacturer or Ingenol Mebutate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ingenol Mebutate manufacturer or Ingenol Mebutate supplier.
PharmaCompass also assists you with knowing the Ingenol Mebutate API Price utilized in the formulation of products. Ingenol Mebutate API Price is not always fixed or binding as the Ingenol Mebutate Price is obtained through a variety of data sources. The Ingenol Mebutate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ingenol Mebutate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ingenol Mebutate, including repackagers and relabelers. The FDA regulates Ingenol Mebutate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ingenol Mebutate 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 Ingenol Mebutate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ingenol Mebutate supplier is an individual or a company that provides Ingenol Mebutate active pharmaceutical ingredient (API) or Ingenol Mebutate finished formulations upon request. The Ingenol Mebutate suppliers may include Ingenol Mebutate API manufacturers, exporters, distributors and traders.
click here to find a list of Ingenol Mebutate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ingenol Mebutate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ingenol Mebutate active pharmaceutical ingredient (API) in detail. Different forms of Ingenol Mebutate DMFs exist exist since differing nations have different regulations, such as Ingenol Mebutate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ingenol Mebutate DMF submitted to regulatory agencies in the US is known as a USDMF. Ingenol Mebutate USDMF includes data on Ingenol Mebutate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ingenol Mebutate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ingenol Mebutate 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 Ingenol Mebutate Drug Master File in Korea (Ingenol Mebutate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ingenol Mebutate. The MFDS reviews the Ingenol Mebutate KDMF as part of the drug registration process and uses the information provided in the Ingenol Mebutate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ingenol Mebutate 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 Ingenol Mebutate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ingenol Mebutate 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 Ingenol Mebutate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ingenol Mebutate 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 Ingenol Mebutate 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 Ingenol Mebutate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ingenol Mebutate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ingenol Mebutate suppliers with NDC on PharmaCompass.
Ingenol Mebutate 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 Ingenol Mebutate 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 Ingenol Mebutate GMP manufacturer or Ingenol Mebutate GMP API supplier for your needs.
A Ingenol Mebutate CoA (Certificate of Analysis) is a formal document that attests to Ingenol Mebutate's compliance with Ingenol Mebutate specifications and serves as a tool for batch-level quality control.
Ingenol Mebutate CoA mostly includes findings from lab analyses of a specific batch. For each Ingenol Mebutate 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.
Ingenol Mebutate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ingenol Mebutate EP), Ingenol Mebutate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ingenol Mebutate USP).
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