X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
35
PharmaCompass offers a list of Erdosteine 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 Erdosteine manufacturer or Erdosteine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Erdosteine manufacturer or Erdosteine supplier.
PharmaCompass also assists you with knowing the Erdosteine API Price utilized in the formulation of products. Erdosteine API Price is not always fixed or binding as the Erdosteine Price is obtained through a variety of data sources. The Erdosteine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Erdosteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erdosteine, including repackagers and relabelers. The FDA regulates Erdosteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erdosteine 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 Erdosteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erdosteine supplier is an individual or a company that provides Erdosteine active pharmaceutical ingredient (API) or Erdosteine finished formulations upon request. The Erdosteine suppliers may include Erdosteine API manufacturers, exporters, distributors and traders.
click here to find a list of Erdosteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Erdosteine Drug Master File in Korea (Erdosteine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Erdosteine. The MFDS reviews the Erdosteine KDMF as part of the drug registration process and uses the information provided in the Erdosteine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Erdosteine 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 Erdosteine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Erdosteine suppliers with KDMF on PharmaCompass.
A Erdosteine written confirmation (Erdosteine WC) is an official document issued by a regulatory agency to a Erdosteine manufacturer, verifying that the manufacturing facility of a Erdosteine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Erdosteine APIs or Erdosteine finished pharmaceutical products to another nation, regulatory agencies frequently require a Erdosteine WC (written confirmation) as part of the regulatory process.
click here to find a list of Erdosteine suppliers with Written Confirmation (WC) on PharmaCompass.
Erdosteine 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 Erdosteine 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 Erdosteine GMP manufacturer or Erdosteine GMP API supplier for your needs.
A Erdosteine CoA (Certificate of Analysis) is a formal document that attests to Erdosteine's compliance with Erdosteine specifications and serves as a tool for batch-level quality control.
Erdosteine CoA mostly includes findings from lab analyses of a specific batch. For each Erdosteine 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.
Erdosteine may be tested according to a variety of international standards, such as European Pharmacopoeia (Erdosteine EP), Erdosteine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Erdosteine USP).
Market Place
