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