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LEBSA- Your strategic API source for niche molecules.
About the Company : Lebsa is an innovative European laboratory that specializes in the synthesis, manufacture and commercialization of APIs with a focus on niche products. With a track record spanning...
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
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ABOUT THIS PAGE
A Octenidine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octenidine Dihydrochloride, including repackagers and relabelers. The FDA regulates Octenidine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octenidine Dihydrochloride 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 Octenidine Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Octenidine Dihydrochloride supplier is an individual or a company that provides Octenidine Dihydrochloride active pharmaceutical ingredient (API) or Octenidine Dihydrochloride finished formulations upon request. The Octenidine Dihydrochloride suppliers may include Octenidine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Octenidine Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Octenidine Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Octenidine Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Octenidine Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Octenidine Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octenidine Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Octenidine Dihydrochloride USDMF includes data on Octenidine Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octenidine Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octenidine Dihydrochloride suppliers with USDMF 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 Octenidine Dihydrochloride Drug Master File in Korea (Octenidine Dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Octenidine Dihydrochloride. The MFDS reviews the Octenidine Dihydrochloride KDMF as part of the drug registration process and uses the information provided in the Octenidine Dihydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Octenidine Dihydrochloride 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 Octenidine Dihydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Octenidine Dihydrochloride suppliers with KDMF on PharmaCompass.
A Octenidine Dihydrochloride written confirmation (Octenidine Dihydrochloride WC) is an official document issued by a regulatory agency to a Octenidine Dihydrochloride manufacturer, verifying that the manufacturing facility of a Octenidine Dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Octenidine Dihydrochloride APIs or Octenidine Dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Octenidine Dihydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Octenidine Dihydrochloride 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 Octenidine Dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Octenidine Dihydrochloride 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 Octenidine Dihydrochloride 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 Octenidine Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Octenidine Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Octenidine Dihydrochloride suppliers with NDC on PharmaCompass.
Octenidine Dihydrochloride 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 Octenidine Dihydrochloride 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 Octenidine Dihydrochloride GMP manufacturer or Octenidine Dihydrochloride GMP API supplier for your needs.
A Octenidine Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Octenidine Dihydrochloride's compliance with Octenidine Dihydrochloride specifications and serves as a tool for batch-level quality control.
Octenidine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Octenidine Dihydrochloride 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.
Octenidine Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Octenidine Dihydrochloride EP), Octenidine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Octenidine Dihydrochloride USP).
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