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