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DOSAGE - SOLUTION;INHALATION - EQ 0.0103% BAS...DOSAGE - SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20837
DOSAGE - SOLUTION;INHALATION - EQ 0.021% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20837
DOSAGE - SOLUTION;INHALATION - EQ 0.042% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20837
DOSAGE - SOLUTION;INHALATION - EQ 0.25% BASE ...DOSAGE - SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20837
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PharmaCompass offers a list of Levalbuterol Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levalbuterol Hydrochloride manufacturer or Levalbuterol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levalbuterol Hydrochloride manufacturer or Levalbuterol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Levalbuterol Hydrochloride API Price utilized in the formulation of products. Levalbuterol Hydrochloride API Price is not always fixed or binding as the Levalbuterol Hydrochloride Price is obtained through a variety of data sources. The Levalbuterol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zopenex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zopenex, including repackagers and relabelers. The FDA regulates Zopenex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zopenex 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 Zopenex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zopenex supplier is an individual or a company that provides Zopenex active pharmaceutical ingredient (API) or Zopenex finished formulations upon request. The Zopenex suppliers may include Zopenex API manufacturers, exporters, distributors and traders.
click here to find a list of Zopenex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zopenex DMF (Drug Master File) is a document detailing the whole manufacturing process of Zopenex active pharmaceutical ingredient (API) in detail. Different forms of Zopenex DMFs exist exist since differing nations have different regulations, such as Zopenex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zopenex DMF submitted to regulatory agencies in the US is known as a USDMF. Zopenex USDMF includes data on Zopenex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zopenex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zopenex suppliers with USDMF on PharmaCompass.
A Zopenex written confirmation (Zopenex WC) is an official document issued by a regulatory agency to a Zopenex manufacturer, verifying that the manufacturing facility of a Zopenex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zopenex APIs or Zopenex finished pharmaceutical products to another nation, regulatory agencies frequently require a Zopenex WC (written confirmation) as part of the regulatory process.
click here to find a list of Zopenex 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 Zopenex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zopenex 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 Zopenex 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 Zopenex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zopenex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zopenex suppliers with NDC on PharmaCompass.
Zopenex 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 Zopenex 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 Zopenex GMP manufacturer or Zopenex GMP API supplier for your needs.
A Zopenex CoA (Certificate of Analysis) is a formal document that attests to Zopenex's compliance with Zopenex specifications and serves as a tool for batch-level quality control.
Zopenex CoA mostly includes findings from lab analyses of a specific batch. For each Zopenex 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.
Zopenex may be tested according to a variety of international standards, such as European Pharmacopoeia (Zopenex EP), Zopenex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zopenex USP).
