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PharmaCompass offers a list of Tacalcitol 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 Tacalcitol manufacturer or Tacalcitol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tacalcitol manufacturer or Tacalcitol supplier.
PharmaCompass also assists you with knowing the Tacalcitol API Price utilized in the formulation of products. Tacalcitol API Price is not always fixed or binding as the Tacalcitol Price is obtained through a variety of data sources. The Tacalcitol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bonalfa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bonalfa, including repackagers and relabelers. The FDA regulates Bonalfa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bonalfa 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 Bonalfa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bonalfa supplier is an individual or a company that provides Bonalfa active pharmaceutical ingredient (API) or Bonalfa finished formulations upon request. The Bonalfa suppliers may include Bonalfa API manufacturers, exporters, distributors and traders.
click here to find a list of Bonalfa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Bonalfa Drug Master File in Japan (Bonalfa JDMF) empowers Bonalfa 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 Bonalfa JDMF during the approval evaluation for pharmaceutical products. At the time of Bonalfa 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 Bonalfa suppliers with JDMF on PharmaCompass.
A Bonalfa CEP of the European Pharmacopoeia monograph is often referred to as a Bonalfa Certificate of Suitability (COS). The purpose of a Bonalfa CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bonalfa EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bonalfa to their clients by showing that a Bonalfa CEP has been issued for it. The manufacturer submits a Bonalfa CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bonalfa CEP holder for the record. Additionally, the data presented in the Bonalfa CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bonalfa DMF.
A Bonalfa CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bonalfa 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 Bonalfa suppliers with CEP (COS) on PharmaCompass.
Bonalfa 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 Bonalfa 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 Bonalfa GMP manufacturer or Bonalfa GMP API supplier for your needs.
A Bonalfa CoA (Certificate of Analysis) is a formal document that attests to Bonalfa's compliance with Bonalfa specifications and serves as a tool for batch-level quality control.
Bonalfa CoA mostly includes findings from lab analyses of a specific batch. For each Bonalfa 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.
Bonalfa may be tested according to a variety of international standards, such as European Pharmacopoeia (Bonalfa EP), Bonalfa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bonalfa USP).
