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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 Vitamin B6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin B6, including repackagers and relabelers. The FDA regulates Vitamin B6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin B6 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 Vitamin B6 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin B6 supplier is an individual or a company that provides Vitamin B6 active pharmaceutical ingredient (API) or Vitamin B6 finished formulations upon request. The Vitamin B6 suppliers may include Vitamin B6 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin B6 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin B6 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin B6 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin B6 DMFs exist exist since differing nations have different regulations, such as Vitamin B6 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin B6 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin B6 USDMF includes data on Vitamin B6's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin B6 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin B6 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 Vitamin B6 Drug Master File in Japan (Vitamin B6 JDMF) empowers Vitamin B6 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 Vitamin B6 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin B6 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 Vitamin B6 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 Vitamin B6 Drug Master File in Korea (Vitamin B6 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vitamin B6. The MFDS reviews the Vitamin B6 KDMF as part of the drug registration process and uses the information provided in the Vitamin B6 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vitamin B6 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 Vitamin B6 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vitamin B6 suppliers with KDMF on PharmaCompass.
A Vitamin B6 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin B6 Certificate of Suitability (COS). The purpose of a Vitamin B6 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin B6 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin B6 to their clients by showing that a Vitamin B6 CEP has been issued for it. The manufacturer submits a Vitamin B6 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin B6 CEP holder for the record. Additionally, the data presented in the Vitamin B6 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin B6 DMF.
A Vitamin B6 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin B6 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 Vitamin B6 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 Vitamin B6 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vitamin B6 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 Vitamin B6 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 Vitamin B6 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin B6 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vitamin B6 suppliers with NDC on PharmaCompass.
Vitamin B6 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 Vitamin B6 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 Vitamin B6 GMP manufacturer or Vitamin B6 GMP API supplier for your needs.
A Vitamin B6 CoA (Certificate of Analysis) is a formal document that attests to Vitamin B6's compliance with Vitamin B6 specifications and serves as a tool for batch-level quality control.
Vitamin B6 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin B6 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.
Vitamin B6 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin B6 EP), Vitamin B6 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin B6 USP).
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