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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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Calcium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Chloride, including repackagers and relabelers. The FDA regulates Calcium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Chloride 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 Calcium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Chloride supplier is an individual or a company that provides Calcium Chloride active pharmaceutical ingredient (API) or Calcium Chloride finished formulations upon request. The Calcium Chloride suppliers may include Calcium Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Calcium Chloride DMFs exist exist since differing nations have different regulations, such as Calcium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Chloride USDMF includes data on Calcium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Chloride 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 Calcium Chloride Drug Master File in Japan (Calcium Chloride JDMF) empowers Calcium Chloride 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 Calcium Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Chloride 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 Calcium Chloride suppliers with JDMF on PharmaCompass.
A Calcium Chloride CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Chloride Certificate of Suitability (COS). The purpose of a Calcium Chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Chloride to their clients by showing that a Calcium Chloride CEP has been issued for it. The manufacturer submits a Calcium Chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Chloride CEP holder for the record. Additionally, the data presented in the Calcium Chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Chloride DMF.
A Calcium Chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Chloride 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 Calcium Chloride 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 Calcium Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium Chloride 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 Calcium Chloride 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 Calcium Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcium Chloride suppliers with NDC on PharmaCompass.
Calcium Chloride 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 Calcium Chloride 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 Calcium Chloride GMP manufacturer or Calcium Chloride GMP API supplier for your needs.
A Calcium Chloride CoA (Certificate of Analysis) is a formal document that attests to Calcium Chloride's compliance with Calcium Chloride specifications and serves as a tool for batch-level quality control.
Calcium Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Chloride 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.
Calcium Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Chloride EP), Calcium Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Chloride USP).
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