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USDMF
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DOSAGE - INJECTABLE;INJECTION - 0.25%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.25%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.5%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.75%
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML
USFDA APPLICATION NUMBER - 16964
DOSAGE - INJECTABLE;INJECTION - 0.25%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.5%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.75%
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091M...DOSAGE - INJECTABLE;INJECTION - 0.75%;0.0091MG/ML
USFDA APPLICATION NUMBER - 18304
DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG...DOSAGE - INJECTABLE;INJECTION - 0.5%;0.0091MG/ML
USFDA APPLICATION NUMBER - 22046
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EUROAPI
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PharmaCompass offers a list of Bupivacaine 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 Bupivacaine Hydrochloride manufacturer or Bupivacaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bupivacaine Hydrochloride manufacturer or Bupivacaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Bupivacaine Hydrochloride API Price utilized in the formulation of products. Bupivacaine Hydrochloride API Price is not always fixed or binding as the Bupivacaine Hydrochloride Price is obtained through a variety of data sources. The Bupivacaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE, including repackagers and relabelers. The FDA regulates BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE supplier is an individual or a company that provides BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE active pharmaceutical ingredient (API) or BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE finished formulations upon request. The BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE suppliers may include BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE API manufacturers, exporters, distributors and traders.
click here to find a list of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE DMF (Drug Master File) is a document detailing the whole manufacturing process of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE active pharmaceutical ingredient (API) in detail. Different forms of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE DMFs exist exist since differing nations have different regulations, such as BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE DMF submitted to regulatory agencies in the US is known as a USDMF. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE USDMF includes data on BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Drug Master File in Japan (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE JDMF) empowers BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE JDMF during the approval evaluation for pharmaceutical products. At the time of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Drug Master File in Korea (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE. The MFDS reviews the BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE KDMF as part of the drug registration process and uses the information provided in the BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE KDMF to evaluate the safety and efficacy of the drug.
After submitting a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE suppliers with KDMF on PharmaCompass.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP of the European Pharmacopoeia monograph is often referred to as a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE Certificate of Suitability (COS). The purpose of a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE to their clients by showing that a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP has been issued for it. The manufacturer submits a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP (COS) as part of the market authorization procedure, and it takes on the role of a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP holder for the record. Additionally, the data presented in the BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE DMF.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE suppliers with CEP (COS) on PharmaCompass.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE written confirmation (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE WC) is an official document issued by a regulatory agency to a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE manufacturer, verifying that the manufacturing facility of a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE APIs or BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE finished pharmaceutical products to another nation, regulatory agencies frequently require a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE WC (written confirmation) as part of the regulatory process.
click here to find a list of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE suppliers with NDC on PharmaCompass.
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE GMP manufacturer or BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE GMP API supplier for your needs.
A BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CoA (Certificate of Analysis) is a formal document that attests to BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE's compliance with BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE specifications and serves as a tool for batch-level quality control.
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE CoA mostly includes findings from lab analyses of a specific batch. For each BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 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 HYDROCHLORIDE; EPINEPHRINE may be tested according to a variety of international standards, such as European Pharmacopoeia (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE EP), BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE USP).
