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