X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
34
PharmaCompass offers a list of Benexate 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 Benexate manufacturer or Benexate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benexate manufacturer or Benexate supplier.
PharmaCompass also assists you with knowing the Benexate API Price utilized in the formulation of products. Benexate API Price is not always fixed or binding as the Benexate Price is obtained through a variety of data sources. The Benexate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Benexate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benexate, including repackagers and relabelers. The FDA regulates Benexate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benexate 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 Benexate supplier is an individual or a company that provides Benexate active pharmaceutical ingredient (API) or Benexate finished formulations upon request. The Benexate suppliers may include Benexate API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Benexate Drug Master File in Korea (Benexate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benexate. The MFDS reviews the Benexate KDMF as part of the drug registration process and uses the information provided in the Benexate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benexate 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 Benexate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benexate suppliers with KDMF on PharmaCompass.
Benexate 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 Benexate 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 Benexate GMP manufacturer or Benexate GMP API supplier for your needs.
A Benexate CoA (Certificate of Analysis) is a formal document that attests to Benexate's compliance with Benexate specifications and serves as a tool for batch-level quality control.
Benexate CoA mostly includes findings from lab analyses of a specific batch. For each Benexate 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.
Benexate may be tested according to a variety of international standards, such as European Pharmacopoeia (Benexate EP), Benexate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benexate USP).
Market Place
