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API SUPPLIERS
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USDMF
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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PharmaCompass offers a list of Otilonium Bromide 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 Otilonium Bromide manufacturer or Otilonium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Otilonium Bromide manufacturer or Otilonium Bromide supplier.
PharmaCompass also assists you with knowing the Otilonium Bromide API Price utilized in the formulation of products. Otilonium Bromide API Price is not always fixed or binding as the Otilonium Bromide Price is obtained through a variety of data sources. The Otilonium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Otilonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Otilonium, including repackagers and relabelers. The FDA regulates Otilonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Otilonium 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 Otilonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Otilonium supplier is an individual or a company that provides Otilonium active pharmaceutical ingredient (API) or Otilonium finished formulations upon request. The Otilonium suppliers may include Otilonium API manufacturers, exporters, distributors and traders.
click here to find a list of Otilonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Otilonium DMF (Drug Master File) is a document detailing the whole manufacturing process of Otilonium active pharmaceutical ingredient (API) in detail. Different forms of Otilonium DMFs exist exist since differing nations have different regulations, such as Otilonium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Otilonium DMF submitted to regulatory agencies in the US is known as a USDMF. Otilonium USDMF includes data on Otilonium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Otilonium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Otilonium 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 Otilonium Drug Master File in Korea (Otilonium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Otilonium. The MFDS reviews the Otilonium KDMF as part of the drug registration process and uses the information provided in the Otilonium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Otilonium 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 Otilonium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Otilonium suppliers with KDMF on PharmaCompass.
A Otilonium written confirmation (Otilonium WC) is an official document issued by a regulatory agency to a Otilonium manufacturer, verifying that the manufacturing facility of a Otilonium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Otilonium APIs or Otilonium finished pharmaceutical products to another nation, regulatory agencies frequently require a Otilonium WC (written confirmation) as part of the regulatory process.
click here to find a list of Otilonium 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 Otilonium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Otilonium 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 Otilonium 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 Otilonium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Otilonium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Otilonium suppliers with NDC on PharmaCompass.
Otilonium 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 Otilonium 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 Otilonium GMP manufacturer or Otilonium GMP API supplier for your needs.
A Otilonium CoA (Certificate of Analysis) is a formal document that attests to Otilonium's compliance with Otilonium specifications and serves as a tool for batch-level quality control.
Otilonium CoA mostly includes findings from lab analyses of a specific batch. For each Otilonium 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.
Otilonium may be tested according to a variety of international standards, such as European Pharmacopoeia (Otilonium EP), Otilonium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Otilonium USP).
