X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
14
PharmaCompass offers a list of Oxytetracycline 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 Oxytetracycline Hydrochloride manufacturer or Oxytetracycline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxytetracycline Hydrochloride manufacturer or Oxytetracycline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Oxytetracycline Hydrochloride API Price utilized in the formulation of products. Oxytetracycline Hydrochloride API Price is not always fixed or binding as the Oxytetracycline Hydrochloride Price is obtained through a variety of data sources. The Oxytetracycline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxytetracycline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxytetracycline Hydrochloride, including repackagers and relabelers. The FDA regulates Oxytetracycline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxytetracycline Hydrochloride supplier is an individual or a company that provides Oxytetracycline Hydrochloride active pharmaceutical ingredient (API) or Oxytetracycline Hydrochloride finished formulations upon request. The Oxytetracycline Hydrochloride suppliers may include Oxytetracycline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Oxytetracycline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxytetracycline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxytetracycline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Oxytetracycline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Oxytetracycline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxytetracycline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxytetracycline Hydrochloride USDMF includes data on Oxytetracycline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxytetracycline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride Drug Master File in Japan (Oxytetracycline Hydrochloride JDMF) empowers Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride suppliers with JDMF on PharmaCompass.
A Oxytetracycline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxytetracycline Hydrochloride Certificate of Suitability (COS). The purpose of a Oxytetracycline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxytetracycline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxytetracycline Hydrochloride to their clients by showing that a Oxytetracycline Hydrochloride CEP has been issued for it. The manufacturer submits a Oxytetracycline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxytetracycline Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxytetracycline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxytetracycline Hydrochloride DMF.
A Oxytetracycline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Oxytetracycline Hydrochloride written confirmation (Oxytetracycline Hydrochloride WC) is an official document issued by a regulatory agency to a Oxytetracycline Hydrochloride manufacturer, verifying that the manufacturing facility of a Oxytetracycline Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxytetracycline Hydrochloride APIs or Oxytetracycline Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxytetracycline Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxytetracycline Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxytetracycline Hydrochloride suppliers with NDC on PharmaCompass.
Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride GMP manufacturer or Oxytetracycline Hydrochloride GMP API supplier for your needs.
A Oxytetracycline Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Oxytetracycline Hydrochloride's compliance with Oxytetracycline Hydrochloride specifications and serves as a tool for batch-level quality control.
Oxytetracycline Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxytetracycline Hydrochloride 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.
Oxytetracycline Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxytetracycline Hydrochloride EP), Oxytetracycline Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxytetracycline Hydrochloride USP).
Market Place
