X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
EU WC
Listed Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
51
PharmaCompass offers a list of Salbutamol Sulphate 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 Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier.
PharmaCompass also assists you with knowing the Salbutamol Sulphate API Price utilized in the formulation of products. Salbutamol Sulphate API Price is not always fixed or binding as the Salbutamol Sulphate Price is obtained through a variety of data sources. The Salbutamol Sulphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A bis(salbutamol); sulfuric acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of bis(salbutamol); sulfuric acid, including repackagers and relabelers. The FDA regulates bis(salbutamol); sulfuric acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A bis(salbutamol); sulfuric acid supplier is an individual or a company that provides bis(salbutamol); sulfuric acid active pharmaceutical ingredient (API) or bis(salbutamol); sulfuric acid finished formulations upon request. The bis(salbutamol); sulfuric acid suppliers may include bis(salbutamol); sulfuric acid API manufacturers, exporters, distributors and traders.
click here to find a list of bis(salbutamol); sulfuric acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A bis(salbutamol); sulfuric acid DMF (Drug Master File) is a document detailing the whole manufacturing process of bis(salbutamol); sulfuric acid active pharmaceutical ingredient (API) in detail. Different forms of bis(salbutamol); sulfuric acid DMFs exist exist since differing nations have different regulations, such as bis(salbutamol); sulfuric acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A bis(salbutamol); sulfuric acid DMF submitted to regulatory agencies in the US is known as a USDMF. bis(salbutamol); sulfuric acid USDMF includes data on bis(salbutamol); sulfuric acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The bis(salbutamol); sulfuric acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid Drug Master File in Japan (bis(salbutamol); sulfuric acid JDMF) empowers bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid JDMF during the approval evaluation for pharmaceutical products. At the time of bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a bis(salbutamol); sulfuric acid Drug Master File in Korea (bis(salbutamol); sulfuric acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of bis(salbutamol); sulfuric acid. The MFDS reviews the bis(salbutamol); sulfuric acid KDMF as part of the drug registration process and uses the information provided in the bis(salbutamol); sulfuric acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a bis(salbutamol); sulfuric acid KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their bis(salbutamol); sulfuric acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of bis(salbutamol); sulfuric acid suppliers with KDMF on PharmaCompass.
A bis(salbutamol); sulfuric acid CEP of the European Pharmacopoeia monograph is often referred to as a bis(salbutamol); sulfuric acid Certificate of Suitability (COS). The purpose of a bis(salbutamol); sulfuric acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of bis(salbutamol); sulfuric acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of bis(salbutamol); sulfuric acid to their clients by showing that a bis(salbutamol); sulfuric acid CEP has been issued for it. The manufacturer submits a bis(salbutamol); sulfuric acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a bis(salbutamol); sulfuric acid CEP holder for the record. Additionally, the data presented in the bis(salbutamol); sulfuric acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the bis(salbutamol); sulfuric acid DMF.
A bis(salbutamol); sulfuric acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. bis(salbutamol); sulfuric acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of bis(salbutamol); sulfuric acid suppliers with CEP (COS) on PharmaCompass.
A bis(salbutamol); sulfuric acid written confirmation (bis(salbutamol); sulfuric acid WC) is an official document issued by a regulatory agency to a bis(salbutamol); sulfuric acid manufacturer, verifying that the manufacturing facility of a bis(salbutamol); sulfuric acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting bis(salbutamol); sulfuric acid APIs or bis(salbutamol); sulfuric acid finished pharmaceutical products to another nation, regulatory agencies frequently require a bis(salbutamol); sulfuric acid WC (written confirmation) as part of the regulatory process.
click here to find a list of bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a bis(salbutamol); sulfuric acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of bis(salbutamol); sulfuric acid suppliers with NDC on PharmaCompass.
bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid 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 bis(salbutamol); sulfuric acid GMP manufacturer or bis(salbutamol); sulfuric acid GMP API supplier for your needs.
A bis(salbutamol); sulfuric acid CoA (Certificate of Analysis) is a formal document that attests to bis(salbutamol); sulfuric acid's compliance with bis(salbutamol); sulfuric acid specifications and serves as a tool for batch-level quality control.
bis(salbutamol); sulfuric acid CoA mostly includes findings from lab analyses of a specific batch. For each bis(salbutamol); sulfuric acid 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.
bis(salbutamol); sulfuric acid may be tested according to a variety of international standards, such as European Pharmacopoeia (bis(salbutamol); sulfuric acid EP), bis(salbutamol); sulfuric acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (bis(salbutamol); sulfuric acid USP).
Market Place
