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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
A Calcium Lactate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Lactate API, including repackagers and relabelers. The FDA regulates Calcium Lactate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Lactate API 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 Lactate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Lactate API supplier is an individual or a company that provides Calcium Lactate API active pharmaceutical ingredient (API) or Calcium Lactate API finished formulations upon request. The Calcium Lactate API suppliers may include Calcium Lactate API API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Lactate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Lactate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Lactate API active pharmaceutical ingredient (API) in detail. Different forms of Calcium Lactate API DMFs exist exist since differing nations have different regulations, such as Calcium Lactate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Lactate API DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Lactate API USDMF includes data on Calcium Lactate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Lactate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Lactate API 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 Lactate API Drug Master File in Japan (Calcium Lactate API JDMF) empowers Calcium Lactate API 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 Lactate API JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Lactate API 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 Lactate API suppliers with JDMF on PharmaCompass.
A Calcium Lactate API CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Lactate API Certificate of Suitability (COS). The purpose of a Calcium Lactate API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Lactate API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Lactate API to their clients by showing that a Calcium Lactate API CEP has been issued for it. The manufacturer submits a Calcium Lactate API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Lactate API CEP holder for the record. Additionally, the data presented in the Calcium Lactate API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Lactate API DMF.
A Calcium Lactate API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Lactate API 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 Lactate API suppliers with CEP (COS) on PharmaCompass.
A Calcium Lactate API written confirmation (Calcium Lactate API WC) is an official document issued by a regulatory agency to a Calcium Lactate API manufacturer, verifying that the manufacturing facility of a Calcium Lactate API active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcium Lactate API APIs or Calcium Lactate API finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcium Lactate API WC (written confirmation) as part of the regulatory process.
click here to find a list of Calcium Lactate API suppliers with Written Confirmation (WC) on PharmaCompass.
Calcium Lactate API 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 Lactate API 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 Lactate API GMP manufacturer or Calcium Lactate API GMP API supplier for your needs.
A Calcium Lactate API CoA (Certificate of Analysis) is a formal document that attests to Calcium Lactate API's compliance with Calcium Lactate API specifications and serves as a tool for batch-level quality control.
Calcium Lactate API CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Lactate API 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 Lactate API may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Lactate API EP), Calcium Lactate API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Lactate API USP).
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