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PharmaCompass offers a list of Oxytocin 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 Oxytocin manufacturer or Oxytocin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxytocin manufacturer or Oxytocin supplier.
PharmaCompass also assists you with knowing the Oxytocin API Price utilized in the formulation of products. Oxytocin API Price is not always fixed or binding as the Oxytocin Price is obtained through a variety of data sources. The Oxytocin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxytocin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxytocin, including repackagers and relabelers. The FDA regulates Oxytocin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxytocin 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 Oxytocin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxytocin supplier is an individual or a company that provides Oxytocin active pharmaceutical ingredient (API) or Oxytocin finished formulations upon request. The Oxytocin suppliers may include Oxytocin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxytocin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxytocin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxytocin active pharmaceutical ingredient (API) in detail. Different forms of Oxytocin DMFs exist exist since differing nations have different regulations, such as Oxytocin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxytocin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxytocin USDMF includes data on Oxytocin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxytocin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxytocin 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 Oxytocin Drug Master File in Japan (Oxytocin JDMF) empowers Oxytocin 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 Oxytocin JDMF during the approval evaluation for pharmaceutical products. At the time of Oxytocin 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 Oxytocin suppliers with JDMF on PharmaCompass.
A Oxytocin CEP of the European Pharmacopoeia monograph is often referred to as a Oxytocin Certificate of Suitability (COS). The purpose of a Oxytocin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxytocin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxytocin to their clients by showing that a Oxytocin CEP has been issued for it. The manufacturer submits a Oxytocin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxytocin CEP holder for the record. Additionally, the data presented in the Oxytocin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxytocin DMF.
A Oxytocin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxytocin 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 Oxytocin suppliers with CEP (COS) on PharmaCompass.
A Oxytocin written confirmation (Oxytocin WC) is an official document issued by a regulatory agency to a Oxytocin manufacturer, verifying that the manufacturing facility of a Oxytocin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxytocin APIs or Oxytocin finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxytocin WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxytocin 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 Oxytocin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxytocin 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 Oxytocin 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 Oxytocin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxytocin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxytocin suppliers with NDC on PharmaCompass.
Oxytocin 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 Oxytocin 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 Oxytocin GMP manufacturer or Oxytocin GMP API supplier for your needs.
A Oxytocin CoA (Certificate of Analysis) is a formal document that attests to Oxytocin's compliance with Oxytocin specifications and serves as a tool for batch-level quality control.
Oxytocin CoA mostly includes findings from lab analyses of a specific batch. For each Oxytocin 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.
Oxytocin may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxytocin EP), Oxytocin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxytocin USP).
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