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Looking for 813-94-5 / Calcium Citrate API manufacturers, exporters & distributors?

Calcium Citrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Calcium Citrate 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 Citrate manufacturer or Calcium Citrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Citrate manufacturer or Calcium Citrate supplier.

PharmaCompass also assists you with knowing the Calcium Citrate API Price utilized in the formulation of products. Calcium Citrate API Price is not always fixed or binding as the Calcium Citrate Price is obtained through a variety of data sources. The Calcium Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Calcium Citrate

Synonyms

813-94-5, Tricalcium dicitrate, Tricalcium citrate, Acicontral, Calcitrate, Calcium citrate, tribasic

Cas Number

813-94-5

Unique Ingredient Identifier (UNII)

86117BWO7P

About Calcium Citrate

A colorless crystalline or white powdery organic, tricarboxylic acid occurring in plants, especially citrus fruits, and used as a flavoring agent, as an antioxidant in foods, and as a sequestrating agent. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

Calcium Citrate Manufacturers

A Calcium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Citrate, including repackagers and relabelers. The FDA regulates Calcium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Calcium Citrate Suppliers

A Calcium Citrate supplier is an individual or a company that provides Calcium Citrate active pharmaceutical ingredient (API) or Calcium Citrate finished formulations upon request. The Calcium Citrate suppliers may include Calcium Citrate API manufacturers, exporters, distributors and traders.

click here to find a list of Calcium Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Calcium Citrate USDMF

A Calcium Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Citrate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Citrate DMFs exist exist since differing nations have different regulations, such as Calcium Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Calcium Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Citrate USDMF includes data on Calcium Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Calcium Citrate suppliers with USDMF on PharmaCompass.

Calcium Citrate WC

A Calcium Citrate written confirmation (Calcium Citrate WC) is an official document issued by a regulatory agency to a Calcium Citrate manufacturer, verifying that the manufacturing facility of a Calcium Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcium Citrate APIs or Calcium Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcium Citrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Calcium Citrate suppliers with Written Confirmation (WC) on PharmaCompass.

Calcium Citrate NDC

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 Citrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Calcium Citrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Citrate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Calcium Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium Citrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Calcium Citrate suppliers with NDC on PharmaCompass.

Calcium Citrate GMP

Calcium Citrate 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 Citrate 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 Citrate GMP manufacturer or Calcium Citrate GMP API supplier for your needs.

Calcium Citrate CoA

A Calcium Citrate CoA (Certificate of Analysis) is a formal document that attests to Calcium Citrate's compliance with Calcium Citrate specifications and serves as a tool for batch-level quality control.

Calcium Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Citrate 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 Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Citrate EP), Calcium Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Citrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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