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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20897
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20897
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20897
DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET)...DOSAGE - GEL;TRANSDERMAL - 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22204
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ABOUT THIS PAGE
14
PharmaCompass offers a list of Oxybutynin Hydrochloride 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 Hydrochloride manufacturer or Oxybutynin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxybutynin Hydrochloride manufacturer or Oxybutynin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Oxybutynin Hydrochloride API Price utilized in the formulation of products. Oxybutynin Hydrochloride API Price is not always fixed or binding as the Oxybutynin Hydrochloride Price is obtained through a variety of data sources. The Oxybutynin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxybutynin Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxybutynin Chloride, including repackagers and relabelers. The FDA regulates Oxybutynin Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxybutynin Chloride 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 Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxybutynin Chloride supplier is an individual or a company that provides Oxybutynin Chloride active pharmaceutical ingredient (API) or Oxybutynin Chloride finished formulations upon request. The Oxybutynin Chloride suppliers may include Oxybutynin Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Oxybutynin Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxybutynin Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxybutynin Chloride active pharmaceutical ingredient (API) in detail. Different forms of Oxybutynin Chloride DMFs exist exist since differing nations have different regulations, such as Oxybutynin Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxybutynin Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxybutynin Chloride USDMF includes data on Oxybutynin Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxybutynin Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxybutynin Chloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Oxybutynin Chloride Drug Master File in Japan (Oxybutynin Chloride JDMF) empowers Oxybutynin Chloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Oxybutynin Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxybutynin Chloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Oxybutynin Chloride suppliers with JDMF 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 Oxybutynin Chloride Drug Master File in Korea (Oxybutynin Chloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxybutynin Chloride. The MFDS reviews the Oxybutynin Chloride KDMF as part of the drug registration process and uses the information provided in the Oxybutynin Chloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxybutynin Chloride 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 Oxybutynin Chloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxybutynin Chloride suppliers with KDMF on PharmaCompass.
A Oxybutynin Chloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxybutynin Chloride Certificate of Suitability (COS). The purpose of a Oxybutynin Chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxybutynin Chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxybutynin Chloride to their clients by showing that a Oxybutynin Chloride CEP has been issued for it. The manufacturer submits a Oxybutynin Chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxybutynin Chloride CEP holder for the record. Additionally, the data presented in the Oxybutynin Chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxybutynin Chloride DMF.
A Oxybutynin Chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxybutynin Chloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Oxybutynin Chloride suppliers with CEP (COS) on PharmaCompass.
A Oxybutynin Chloride written confirmation (Oxybutynin Chloride WC) is an official document issued by a regulatory agency to a Oxybutynin Chloride manufacturer, verifying that the manufacturing facility of a Oxybutynin Chloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxybutynin Chloride APIs or Oxybutynin Chloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxybutynin Chloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxybutynin Chloride 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 Oxybutynin Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxybutynin Chloride 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 Chloride 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 Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxybutynin Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxybutynin Chloride suppliers with NDC on PharmaCompass.
Oxybutynin Chloride 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 Chloride 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 Chloride GMP manufacturer or Oxybutynin Chloride GMP API supplier for your needs.
A Oxybutynin Chloride CoA (Certificate of Analysis) is a formal document that attests to Oxybutynin Chloride's compliance with Oxybutynin Chloride specifications and serves as a tool for batch-level quality control.
Oxybutynin Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxybutynin Chloride 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 Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxybutynin Chloride EP), Oxybutynin Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxybutynin Chloride USP).
