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