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ABOUT THIS PAGE
A Calcium Chloride Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Chloride Dihydrate, including repackagers and relabelers. The FDA regulates Calcium Chloride Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Chloride Dihydrate 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 Chloride Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Chloride Dihydrate supplier is an individual or a company that provides Calcium Chloride Dihydrate active pharmaceutical ingredient (API) or Calcium Chloride Dihydrate finished formulations upon request. The Calcium Chloride Dihydrate suppliers may include Calcium Chloride Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Chloride Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Chloride Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Chloride Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Chloride Dihydrate DMFs exist exist since differing nations have different regulations, such as Calcium Chloride Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Chloride Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Chloride Dihydrate USDMF includes data on Calcium Chloride Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Chloride Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Chloride Dihydrate 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 Calcium Chloride Dihydrate Drug Master File in Korea (Calcium Chloride Dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcium Chloride Dihydrate. The MFDS reviews the Calcium Chloride Dihydrate KDMF as part of the drug registration process and uses the information provided in the Calcium Chloride Dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcium Chloride Dihydrate 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 Calcium Chloride Dihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcium Chloride Dihydrate suppliers with KDMF on PharmaCompass.
Calcium Chloride Dihydrate 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 Chloride Dihydrate 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 Chloride Dihydrate GMP manufacturer or Calcium Chloride Dihydrate GMP API supplier for your needs.
A Calcium Chloride Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Calcium Chloride Dihydrate's compliance with Calcium Chloride Dihydrate specifications and serves as a tool for batch-level quality control.
Calcium Chloride Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Chloride Dihydrate 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 Chloride Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Chloride Dihydrate EP), Calcium Chloride Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Chloride Dihydrate USP).
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