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