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