X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
92
PharmaCompass offers a list of Vitamin B12 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 Vitamin B12 manufacturer or Vitamin B12 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin B12 manufacturer or Vitamin B12 supplier.
PharmaCompass also assists you with knowing the Vitamin B12 API Price utilized in the formulation of products. Vitamin B12 API Price is not always fixed or binding as the Vitamin B12 Price is obtained through a variety of data sources. The Vitamin B12 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cyanocobalamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyanocobalamin, including repackagers and relabelers. The FDA regulates Cyanocobalamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyanocobalamin 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 Cyanocobalamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyanocobalamin supplier is an individual or a company that provides Cyanocobalamin active pharmaceutical ingredient (API) or Cyanocobalamin finished formulations upon request. The Cyanocobalamin suppliers may include Cyanocobalamin API manufacturers, exporters, distributors and traders.
click here to find a list of Cyanocobalamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyanocobalamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyanocobalamin active pharmaceutical ingredient (API) in detail. Different forms of Cyanocobalamin DMFs exist exist since differing nations have different regulations, such as Cyanocobalamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyanocobalamin DMF submitted to regulatory agencies in the US is known as a USDMF. Cyanocobalamin USDMF includes data on Cyanocobalamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyanocobalamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyanocobalamin 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 Cyanocobalamin Drug Master File in Japan (Cyanocobalamin JDMF) empowers Cyanocobalamin 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 Cyanocobalamin JDMF during the approval evaluation for pharmaceutical products. At the time of Cyanocobalamin 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 Cyanocobalamin suppliers with JDMF on PharmaCompass.
A Cyanocobalamin CEP of the European Pharmacopoeia monograph is often referred to as a Cyanocobalamin Certificate of Suitability (COS). The purpose of a Cyanocobalamin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cyanocobalamin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cyanocobalamin to their clients by showing that a Cyanocobalamin CEP has been issued for it. The manufacturer submits a Cyanocobalamin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cyanocobalamin CEP holder for the record. Additionally, the data presented in the Cyanocobalamin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cyanocobalamin DMF.
A Cyanocobalamin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cyanocobalamin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cyanocobalamin suppliers with CEP (COS) 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 Cyanocobalamin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cyanocobalamin 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 Cyanocobalamin 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 Cyanocobalamin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cyanocobalamin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cyanocobalamin suppliers with NDC on PharmaCompass.
Cyanocobalamin 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 Cyanocobalamin 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 Cyanocobalamin GMP manufacturer or Cyanocobalamin GMP API supplier for your needs.
A Cyanocobalamin CoA (Certificate of Analysis) is a formal document that attests to Cyanocobalamin's compliance with Cyanocobalamin specifications and serves as a tool for batch-level quality control.
Cyanocobalamin CoA mostly includes findings from lab analyses of a specific batch. For each Cyanocobalamin 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.
Cyanocobalamin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cyanocobalamin EP), Cyanocobalamin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cyanocobalamin USP).
Market Place
