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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]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
17
PharmaCompass offers a list of Calcium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Calcium manufacturer or Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium manufacturer or Calcium supplier.
A Elemental calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elemental calcium, including repackagers and relabelers. The FDA regulates Elemental calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elemental calcium 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 Elemental calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Elemental calcium supplier is an individual or a company that provides Elemental calcium active pharmaceutical ingredient (API) or Elemental calcium finished formulations upon request. The Elemental calcium suppliers may include Elemental calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Elemental calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Elemental calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Elemental calcium active pharmaceutical ingredient (API) in detail. Different forms of Elemental calcium DMFs exist exist since differing nations have different regulations, such as Elemental calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elemental calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Elemental calcium USDMF includes data on Elemental calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elemental calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elemental calcium 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 Elemental calcium Drug Master File in Japan (Elemental calcium JDMF) empowers Elemental calcium 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 Elemental calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Elemental calcium 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 Elemental calcium suppliers with JDMF on PharmaCompass.
A Elemental calcium CEP of the European Pharmacopoeia monograph is often referred to as a Elemental calcium Certificate of Suitability (COS). The purpose of a Elemental calcium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Elemental calcium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Elemental calcium to their clients by showing that a Elemental calcium CEP has been issued for it. The manufacturer submits a Elemental calcium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Elemental calcium CEP holder for the record. Additionally, the data presented in the Elemental calcium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Elemental calcium DMF.
A Elemental calcium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Elemental calcium 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 Elemental calcium suppliers with CEP (COS) on PharmaCompass.
A Elemental calcium written confirmation (Elemental calcium WC) is an official document issued by a regulatory agency to a Elemental calcium manufacturer, verifying that the manufacturing facility of a Elemental calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Elemental calcium APIs or Elemental calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Elemental calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Elemental calcium 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 Elemental calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elemental calcium 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 Elemental calcium 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 Elemental calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elemental calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elemental calcium suppliers with NDC on PharmaCompass.
Elemental calcium 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 Elemental calcium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Elemental calcium GMP manufacturer or Elemental calcium GMP API supplier for your needs.
A Elemental calcium CoA (Certificate of Analysis) is a formal document that attests to Elemental calcium's compliance with Elemental calcium specifications and serves as a tool for batch-level quality control.
Elemental calcium CoA mostly includes findings from lab analyses of a specific batch. For each Elemental calcium 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.
Elemental calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Elemental calcium EP), Elemental calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elemental calcium USP).
