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