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ABOUT THIS PAGE
A Calcium Oxybate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Oxybate, including repackagers and relabelers. The FDA regulates Calcium Oxybate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Oxybate 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 Oxybate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Oxybate supplier is an individual or a company that provides Calcium Oxybate active pharmaceutical ingredient (API) or Calcium Oxybate finished formulations upon request. The Calcium Oxybate suppliers may include Calcium Oxybate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Oxybate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Oxybate DMFs exist exist since differing nations have different regulations, such as Calcium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Oxybate USDMF includes data on Calcium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Oxybate suppliers with USDMF 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 Calcium Oxybate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium Oxybate 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 Calcium Oxybate 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 Calcium Oxybate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium Oxybate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcium Oxybate suppliers with NDC on PharmaCompass.
Calcium Oxybate 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 Oxybate 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 Oxybate GMP manufacturer or Calcium Oxybate GMP API supplier for your needs.
A Calcium Oxybate CoA (Certificate of Analysis) is a formal document that attests to Calcium Oxybate's compliance with Calcium Oxybate specifications and serves as a tool for batch-level quality control.
Calcium Oxybate CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Oxybate 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 Oxybate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Oxybate EP), Calcium Oxybate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Oxybate USP).
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