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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 16682
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 17512
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 17608
DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.9...DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
USFDA APPLICATION NUMBER - 18469
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 18883
DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30M...DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19416
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
USFDA APPLICATION NUMBER - 19685
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)
USFDA APPLICATION NUMBER - 200656
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20163
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20171
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/10...DOSAGE - SOLUTION;INTRAPERITONEAL - 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
USFDA APPLICATION NUMBER - 20183
DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 207026
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3....DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 207026
DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3M...DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML
USFDA APPLICATION NUMBER - 20742
DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 21117
DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
USFDA APPLICATION NUMBER - 21703
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ABOUT THIS PAGE
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PharmaCompass offers a list of Calcium Chloride 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 Calcium Chloride manufacturer or Calcium Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Chloride manufacturer or Calcium Chloride supplier.
PharmaCompass also assists you with knowing the Calcium Chloride API Price utilized in the formulation of products. Calcium Chloride API Price is not always fixed or binding as the Calcium Chloride Price is obtained through a variety of data sources. The Calcium Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BSS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BSS, including repackagers and relabelers. The FDA regulates BSS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BSS 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 BSS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BSS supplier is an individual or a company that provides BSS active pharmaceutical ingredient (API) or BSS finished formulations upon request. The BSS suppliers may include BSS API manufacturers, exporters, distributors and traders.
click here to find a list of BSS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BSS DMF (Drug Master File) is a document detailing the whole manufacturing process of BSS active pharmaceutical ingredient (API) in detail. Different forms of BSS DMFs exist exist since differing nations have different regulations, such as BSS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BSS DMF submitted to regulatory agencies in the US is known as a USDMF. BSS USDMF includes data on BSS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BSS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BSS 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 BSS Drug Master File in Japan (BSS JDMF) empowers BSS 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 BSS JDMF during the approval evaluation for pharmaceutical products. At the time of BSS 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 BSS suppliers with JDMF on PharmaCompass.
A BSS CEP of the European Pharmacopoeia monograph is often referred to as a BSS Certificate of Suitability (COS). The purpose of a BSS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BSS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BSS to their clients by showing that a BSS CEP has been issued for it. The manufacturer submits a BSS CEP (COS) as part of the market authorization procedure, and it takes on the role of a BSS CEP holder for the record. Additionally, the data presented in the BSS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BSS DMF.
A BSS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BSS 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 BSS suppliers with CEP (COS) 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 BSS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BSS 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 BSS 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 BSS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BSS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BSS suppliers with NDC on PharmaCompass.
BSS 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 BSS 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 BSS GMP manufacturer or BSS GMP API supplier for your needs.
A BSS CoA (Certificate of Analysis) is a formal document that attests to BSS's compliance with BSS specifications and serves as a tool for batch-level quality control.
BSS CoA mostly includes findings from lab analyses of a specific batch. For each BSS 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.
BSS may be tested according to a variety of international standards, such as European Pharmacopoeia (BSS EP), BSS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BSS USP).
