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ABOUT THIS PAGE
A Zilucoplan Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zilucoplan Sodium, including repackagers and relabelers. The FDA regulates Zilucoplan Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zilucoplan Sodium 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 Zilucoplan Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zilucoplan Sodium supplier is an individual or a company that provides Zilucoplan Sodium active pharmaceutical ingredient (API) or Zilucoplan Sodium finished formulations upon request. The Zilucoplan Sodium suppliers may include Zilucoplan Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Zilucoplan Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Zilucoplan Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zilucoplan Sodium 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 Zilucoplan Sodium 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 Zilucoplan Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zilucoplan Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zilucoplan Sodium suppliers with NDC on PharmaCompass.
Zilucoplan Sodium 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 Zilucoplan Sodium 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 Zilucoplan Sodium GMP manufacturer or Zilucoplan Sodium GMP API supplier for your needs.
A Zilucoplan Sodium CoA (Certificate of Analysis) is a formal document that attests to Zilucoplan Sodium's compliance with Zilucoplan Sodium specifications and serves as a tool for batch-level quality control.
Zilucoplan Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Zilucoplan Sodium 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.
Zilucoplan Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Zilucoplan Sodium EP), Zilucoplan Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zilucoplan Sodium USP).
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