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