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JDMF
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API SUPPLIERS
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18236
Submission : 2005-04-01
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-14
DMF Number : 20557
Submission : 2007-05-23
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18433
Submission : 2005-06-16
Status :
Type : II
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API Imports and Exports
Drugs in Development
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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- SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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...DOSAGE - SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Parenteral
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Sodium Chloride Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral, Thickeners and Stabilizers
Excipient Details : Used as a chelating agent in cell culture media, downstream and as a chelator stabilizer in Biopharmaceutical formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Disodium Edetate Excipient
Controlled & Modified Release
Thickeners and Stabilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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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 Levalbuterol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levalbuterol Hydrochloride, including repackagers and relabelers. The FDA regulates Levalbuterol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levalbuterol Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levalbuterol Hydrochloride supplier is an individual or a company that provides Levalbuterol Hydrochloride active pharmaceutical ingredient (API) or Levalbuterol Hydrochloride finished formulations upon request. The Levalbuterol Hydrochloride suppliers may include Levalbuterol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Levalbuterol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levalbuterol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Levalbuterol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Levalbuterol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Levalbuterol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levalbuterol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Levalbuterol Hydrochloride USDMF includes data on Levalbuterol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levalbuterol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levalbuterol Hydrochloride suppliers with USDMF on PharmaCompass.
A Levalbuterol Hydrochloride written confirmation (Levalbuterol Hydrochloride WC) is an official document issued by a regulatory agency to a Levalbuterol Hydrochloride manufacturer, verifying that the manufacturing facility of a Levalbuterol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levalbuterol Hydrochloride APIs or Levalbuterol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Levalbuterol Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Levalbuterol Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levalbuterol Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levalbuterol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levalbuterol Hydrochloride suppliers with NDC on PharmaCompass.
Levalbuterol Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Levalbuterol Hydrochloride GMP API supplier for your needs.
A Levalbuterol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Levalbuterol Hydrochloride's compliance with Levalbuterol Hydrochloride specifications and serves as a tool for batch-level quality control.
Levalbuterol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Levalbuterol Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Levalbuterol Hydrochloride EP), Levalbuterol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levalbuterol Hydrochloride USP).
