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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Hydroxocobalamin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxocobalamin Acetate, including repackagers and relabelers. The FDA regulates Hydroxocobalamin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxocobalamin Acetate supplier is an individual or a company that provides Hydroxocobalamin Acetate active pharmaceutical ingredient (API) or Hydroxocobalamin Acetate finished formulations upon request. The Hydroxocobalamin Acetate suppliers may include Hydroxocobalamin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxocobalamin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxocobalamin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxocobalamin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Hydroxocobalamin Acetate DMFs exist exist since differing nations have different regulations, such as Hydroxocobalamin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxocobalamin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxocobalamin Acetate USDMF includes data on Hydroxocobalamin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxocobalamin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate Drug Master File in Japan (Hydroxocobalamin Acetate JDMF) empowers Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate Drug Master File in Korea (Hydroxocobalamin Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydroxocobalamin Acetate. The MFDS reviews the Hydroxocobalamin Acetate KDMF as part of the drug registration process and uses the information provided in the Hydroxocobalamin Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydroxocobalamin Acetate suppliers with KDMF on PharmaCompass.
A Hydroxocobalamin Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxocobalamin Acetate Certificate of Suitability (COS). The purpose of a Hydroxocobalamin Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxocobalamin Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxocobalamin Acetate to their clients by showing that a Hydroxocobalamin Acetate CEP has been issued for it. The manufacturer submits a Hydroxocobalamin Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxocobalamin Acetate CEP holder for the record. Additionally, the data presented in the Hydroxocobalamin Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxocobalamin Acetate DMF.
A Hydroxocobalamin Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate suppliers with CEP (COS) on PharmaCompass.
A Hydroxocobalamin Acetate written confirmation (Hydroxocobalamin Acetate WC) is an official document issued by a regulatory agency to a Hydroxocobalamin Acetate manufacturer, verifying that the manufacturing facility of a Hydroxocobalamin Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydroxocobalamin Acetate APIs or Hydroxocobalamin Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydroxocobalamin Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxocobalamin Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxocobalamin Acetate suppliers with NDC on PharmaCompass.
Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate 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 Hydroxocobalamin Acetate GMP manufacturer or Hydroxocobalamin Acetate GMP API supplier for your needs.
A Hydroxocobalamin Acetate CoA (Certificate of Analysis) is a formal document that attests to Hydroxocobalamin Acetate's compliance with Hydroxocobalamin Acetate specifications and serves as a tool for batch-level quality control.
Hydroxocobalamin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxocobalamin Acetate 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.
Hydroxocobalamin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxocobalamin Acetate EP), Hydroxocobalamin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxocobalamin Acetate USP).
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