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PharmaCompass offers a list of Pentetic Acid 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 Pentetic Acid manufacturer or Pentetic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pentetic Acid manufacturer or Pentetic Acid supplier.
PharmaCompass also assists you with knowing the Pentetic Acid API Price utilized in the formulation of products. Pentetic Acid API Price is not always fixed or binding as the Pentetic Acid Price is obtained through a variety of data sources. The Pentetic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pentetate Calcium Trisodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentetate Calcium Trisodium, including repackagers and relabelers. The FDA regulates Pentetate Calcium Trisodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentetate Calcium Trisodium supplier is an individual or a company that provides Pentetate Calcium Trisodium active pharmaceutical ingredient (API) or Pentetate Calcium Trisodium finished formulations upon request. The Pentetate Calcium Trisodium suppliers may include Pentetate Calcium Trisodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pentetate Calcium Trisodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentetate Calcium Trisodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentetate Calcium Trisodium active pharmaceutical ingredient (API) in detail. Different forms of Pentetate Calcium Trisodium DMFs exist exist since differing nations have different regulations, such as Pentetate Calcium Trisodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentetate Calcium Trisodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pentetate Calcium Trisodium USDMF includes data on Pentetate Calcium Trisodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentetate Calcium Trisodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentetate Calcium Trisodium suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pentetate Calcium Trisodium Drug Master File in Korea (Pentetate Calcium Trisodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pentetate Calcium Trisodium. The MFDS reviews the Pentetate Calcium Trisodium KDMF as part of the drug registration process and uses the information provided in the Pentetate Calcium Trisodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pentetate Calcium Trisodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pentetate Calcium Trisodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pentetate Calcium Trisodium suppliers with KDMF 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 Pentetate Calcium Trisodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentetate Calcium Trisodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pentetate Calcium Trisodium suppliers with NDC on PharmaCompass.
Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium GMP manufacturer or Pentetate Calcium Trisodium GMP API supplier for your needs.
A Pentetate Calcium Trisodium CoA (Certificate of Analysis) is a formal document that attests to Pentetate Calcium Trisodium's compliance with Pentetate Calcium Trisodium specifications and serves as a tool for batch-level quality control.
Pentetate Calcium Trisodium CoA mostly includes findings from lab analyses of a specific batch. For each Pentetate Calcium Trisodium 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.
Pentetate Calcium Trisodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentetate Calcium Trisodium EP), Pentetate Calcium Trisodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentetate Calcium Trisodium USP).
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