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