API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
47
PharmaCompass offers a list of Orkambi 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 Orkambi manufacturer or Orkambi supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orkambi manufacturer or Orkambi supplier.
PharmaCompass also assists you with knowing the Orkambi API Price utilized in the formulation of products. Orkambi API Price is not always fixed or binding as the Orkambi Price is obtained through a variety of data sources. The Orkambi Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lumacaftor / Ivacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumacaftor / Ivacaftor, including repackagers and relabelers. The FDA regulates Lumacaftor / Ivacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumacaftor / Ivacaftor 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 Lumacaftor / Ivacaftor supplier is an individual or a company that provides Lumacaftor / Ivacaftor active pharmaceutical ingredient (API) or Lumacaftor / Ivacaftor finished formulations upon request. The Lumacaftor / Ivacaftor suppliers may include Lumacaftor / Ivacaftor API manufacturers, exporters, distributors and traders.
Lumacaftor / Ivacaftor 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 Lumacaftor / Ivacaftor 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 Lumacaftor / Ivacaftor GMP manufacturer or Lumacaftor / Ivacaftor GMP API supplier for your needs.
A Lumacaftor / Ivacaftor CoA (Certificate of Analysis) is a formal document that attests to Lumacaftor / Ivacaftor's compliance with Lumacaftor / Ivacaftor specifications and serves as a tool for batch-level quality control.
Lumacaftor / Ivacaftor CoA mostly includes findings from lab analyses of a specific batch. For each Lumacaftor / Ivacaftor 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.
Lumacaftor / Ivacaftor may be tested according to a variety of international standards, such as European Pharmacopoeia (Lumacaftor / Ivacaftor EP), Lumacaftor / Ivacaftor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lumacaftor / Ivacaftor USP).