Synopsis
Synopsis
0
EU WC
0
KDMF
0
VMF
0
Australia
0
US Patents
0
US Exclusivities
0
Health Canada Patents
Annual Reports
NA
0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Molecular Weight | 75.53 g/mol |
---|---|
Molecular Formula | CaCl+ |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 1 |
Rotatable Bond Count | 0 |
Exact Mass | 74.9314435 g/mol |
Monoisotopic Mass | 74.9314435 g/mol |
Topological Polar Surface Area | 0 Ų |
Heavy Atom Count | 2 |
Formal Charge | 1 |
Complexity | 0 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34464
Submission : 2020-01-31
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2013-07-02
DMF Number : 14996
Submission : 2000-08-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-24
Pay. Date : 2014-03-25
DMF Number : 18502
Submission : 2005-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24706
Submission : 2011-02-28
Status : Inactive
Type : II
Certificate Number : CEP 2015-352 - Rev 02
Status : Valid
Issue Date : 2025-03-21
Type : Chemical
Substance Number : 15
Certificate Number : R1-CEP 2006-263 - Rev 01
Status : Valid
Issue Date : 2016-05-19
Type : Chemical
Substance Number : 15
Certificate Number : R1-CEP 2007-356 - Rev 01
Status : Valid
Issue Date : 2018-08-28
Type : Chemical
Substance Number : 15
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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.
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A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, including repackagers and relabelers. The FDA regulates DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER supplier is an individual or a company that provides DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) or DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER finished formulations upon request. The DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER suppliers may include DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER API manufacturers, exporters, distributors and traders.
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A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER DMF (Drug Master File) is a document detailing the whole manufacturing process of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) in detail. Different forms of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER DMFs exist exist since differing nations have different regulations, such as DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER DMF submitted to regulatory agencies in the US is known as a USDMF. DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER USDMF includes data on DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Drug Master File in Japan (DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER JDMF) empowers DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER 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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER JDMF during the approval evaluation for pharmaceutical products. At the time of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP of the European Pharmacopoeia monograph is often referred to as a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Certificate of Suitability (COS). The purpose of a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER to their clients by showing that a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP has been issued for it. The manufacturer submits a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP (COS) as part of the market authorization procedure, and it takes on the role of a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP holder for the record. Additionally, the data presented in the DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER DMF.
A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER 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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER 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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER NDC to their finished compounded human drug products, they may choose to do so.
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DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER 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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER 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 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER GMP manufacturer or DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER GMP API supplier for your needs.
A DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CoA (Certificate of Analysis) is a formal document that attests to DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER's compliance with DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER specifications and serves as a tool for batch-level quality control.
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DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER may be tested according to a variety of international standards, such as European Pharmacopoeia (DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER EP), DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER USP).