![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-desktop-headergif-72716.gif)
![EuroAPI Header](https://www.pharmacompass.com/image/flap/euroapi-w34-mob-headergif-95876.gif)
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
57
PharmaCompass offers a list of Methacholine Chloride 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 Methacholine Chloride manufacturer or Methacholine Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methacholine Chloride manufacturer or Methacholine Chloride supplier.
PharmaCompass also assists you with knowing the Methacholine Chloride API Price utilized in the formulation of products. Methacholine Chloride API Price is not always fixed or binding as the Methacholine Chloride Price is obtained through a variety of data sources. The Methacholine Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Methacholine Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methacholine Chloride, including repackagers and relabelers. The FDA regulates Methacholine Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methacholine Chloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Methacholine Chloride supplier is an individual or a company that provides Methacholine Chloride active pharmaceutical ingredient (API) or Methacholine Chloride finished formulations upon request. The Methacholine Chloride suppliers may include Methacholine Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methacholine Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methacholine Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methacholine Chloride active pharmaceutical ingredient (API) in detail. Different forms of Methacholine Chloride DMFs exist exist since differing nations have different regulations, such as Methacholine Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methacholine Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methacholine Chloride USDMF includes data on Methacholine Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methacholine Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methacholine Chloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Methacholine Chloride Drug Master File in Japan (Methacholine Chloride JDMF) empowers Methacholine Chloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Methacholine Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Methacholine Chloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Methacholine Chloride suppliers with JDMF 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 Methacholine Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methacholine Chloride 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 Methacholine Chloride 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 Methacholine Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methacholine Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methacholine Chloride suppliers with NDC on PharmaCompass.
Methacholine Chloride 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 Methacholine Chloride 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 Methacholine Chloride GMP manufacturer or Methacholine Chloride GMP API supplier for your needs.
A Methacholine Chloride CoA (Certificate of Analysis) is a formal document that attests to Methacholine Chloride's compliance with Methacholine Chloride specifications and serves as a tool for batch-level quality control.
Methacholine Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Methacholine Chloride 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.
Methacholine Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Methacholine Chloride EP), Methacholine Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methacholine Chloride USP).