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