X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
64
PharmaCompass offers a list of Phenylephrine Bitartrate 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 Phenylephrine Bitartrate manufacturer or Phenylephrine Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenylephrine Bitartrate manufacturer or Phenylephrine Bitartrate supplier.
PharmaCompass also assists you with knowing the Phenylephrine Bitartrate API Price utilized in the formulation of products. Phenylephrine Bitartrate API Price is not always fixed or binding as the Phenylephrine Bitartrate Price is obtained through a variety of data sources. The Phenylephrine Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Phenylephrine Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine Bitartrate, including repackagers and relabelers. The FDA regulates Phenylephrine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine Bitartrate 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 Phenylephrine Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylephrine Bitartrate supplier is an individual or a company that provides Phenylephrine Bitartrate active pharmaceutical ingredient (API) or Phenylephrine Bitartrate finished formulations upon request. The Phenylephrine Bitartrate suppliers may include Phenylephrine Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylephrine Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylephrine Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylephrine Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Phenylephrine Bitartrate DMFs exist exist since differing nations have different regulations, such as Phenylephrine Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylephrine Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylephrine Bitartrate USDMF includes data on Phenylephrine Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylephrine Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylephrine Bitartrate suppliers with USDMF on PharmaCompass.
A Phenylephrine Bitartrate written confirmation (Phenylephrine Bitartrate WC) is an official document issued by a regulatory agency to a Phenylephrine Bitartrate manufacturer, verifying that the manufacturing facility of a Phenylephrine Bitartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Phenylephrine Bitartrate APIs or Phenylephrine Bitartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Phenylephrine Bitartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Phenylephrine Bitartrate 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 Phenylephrine Bitartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Phenylephrine Bitartrate 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 Phenylephrine Bitartrate 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 Phenylephrine Bitartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenylephrine Bitartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Phenylephrine Bitartrate suppliers with NDC on PharmaCompass.
Phenylephrine Bitartrate 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 Phenylephrine Bitartrate 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 Phenylephrine Bitartrate GMP manufacturer or Phenylephrine Bitartrate GMP API supplier for your needs.
A Phenylephrine Bitartrate CoA (Certificate of Analysis) is a formal document that attests to Phenylephrine Bitartrate's compliance with Phenylephrine Bitartrate specifications and serves as a tool for batch-level quality control.
Phenylephrine Bitartrate CoA mostly includes findings from lab analyses of a specific batch. For each Phenylephrine Bitartrate 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.
Phenylephrine Bitartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Phenylephrine Bitartrate EP), Phenylephrine Bitartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phenylephrine Bitartrate USP).
Market Place
