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