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API SUPPLIERS
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Aspen API. More than just an API™
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
JDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Australia
Brand Name : Buscopan
Dosage Form : injection
Dosage Strength : 20 mg/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Australia
Brand Name : Buscopan
Dosage Form : injection
Dosage Strength : 20 mg/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Australia
Brand Name : Buscopan
Dosage Form : injection
Dosage Strength : 20 mg/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
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NEWS #PharmaBuzz
10 Aug 2017
// ANVISA
14 Feb 2017
// Sudip Kar-Gupta REUTERS
08 Apr 2015
// ANVISA
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ABOUT THIS PAGE
75
PharmaCompass offers a list of Hyoscine Butyl 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 Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hyoscine Butyl Bromide manufacturer or Hyoscine Butyl Bromide supplier.
PharmaCompass also assists you with knowing the Hyoscine Butyl Bromide API Price utilized in the formulation of products. Hyoscine Butyl Bromide API Price is not always fixed or binding as the Hyoscine Butyl Bromide Price is obtained through a variety of data sources. The Hyoscine Butyl Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hyoscinbutylbromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscinbutylbromide, including repackagers and relabelers. The FDA regulates Hyoscinbutylbromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscinbutylbromide 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 Hyoscinbutylbromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyoscinbutylbromide supplier is an individual or a company that provides Hyoscinbutylbromide active pharmaceutical ingredient (API) or Hyoscinbutylbromide finished formulations upon request. The Hyoscinbutylbromide suppliers may include Hyoscinbutylbromide API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscinbutylbromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyoscinbutylbromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyoscinbutylbromide active pharmaceutical ingredient (API) in detail. Different forms of Hyoscinbutylbromide DMFs exist exist since differing nations have different regulations, such as Hyoscinbutylbromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyoscinbutylbromide DMF submitted to regulatory agencies in the US is known as a USDMF. Hyoscinbutylbromide USDMF includes data on Hyoscinbutylbromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyoscinbutylbromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyoscinbutylbromide 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 Hyoscinbutylbromide Drug Master File in Japan (Hyoscinbutylbromide JDMF) empowers Hyoscinbutylbromide 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 Hyoscinbutylbromide JDMF during the approval evaluation for pharmaceutical products. At the time of Hyoscinbutylbromide 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 Hyoscinbutylbromide suppliers with JDMF 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 Hyoscinbutylbromide Drug Master File in Korea (Hyoscinbutylbromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hyoscinbutylbromide. The MFDS reviews the Hyoscinbutylbromide KDMF as part of the drug registration process and uses the information provided in the Hyoscinbutylbromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hyoscinbutylbromide 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 Hyoscinbutylbromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hyoscinbutylbromide suppliers with KDMF on PharmaCompass.
A Hyoscinbutylbromide CEP of the European Pharmacopoeia monograph is often referred to as a Hyoscinbutylbromide Certificate of Suitability (COS). The purpose of a Hyoscinbutylbromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyoscinbutylbromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyoscinbutylbromide to their clients by showing that a Hyoscinbutylbromide CEP has been issued for it. The manufacturer submits a Hyoscinbutylbromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyoscinbutylbromide CEP holder for the record. Additionally, the data presented in the Hyoscinbutylbromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyoscinbutylbromide DMF.
A Hyoscinbutylbromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyoscinbutylbromide 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 Hyoscinbutylbromide suppliers with CEP (COS) on PharmaCompass.
A Hyoscinbutylbromide written confirmation (Hyoscinbutylbromide WC) is an official document issued by a regulatory agency to a Hyoscinbutylbromide manufacturer, verifying that the manufacturing facility of a Hyoscinbutylbromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyoscinbutylbromide APIs or Hyoscinbutylbromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyoscinbutylbromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyoscinbutylbromide 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 Hyoscinbutylbromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyoscinbutylbromide 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 Hyoscinbutylbromide 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 Hyoscinbutylbromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyoscinbutylbromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyoscinbutylbromide suppliers with NDC on PharmaCompass.
Hyoscinbutylbromide 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 Hyoscinbutylbromide 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 Hyoscinbutylbromide GMP manufacturer or Hyoscinbutylbromide GMP API supplier for your needs.
A Hyoscinbutylbromide CoA (Certificate of Analysis) is a formal document that attests to Hyoscinbutylbromide's compliance with Hyoscinbutylbromide specifications and serves as a tool for batch-level quality control.
Hyoscinbutylbromide CoA mostly includes findings from lab analyses of a specific batch. For each Hyoscinbutylbromide 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.
Hyoscinbutylbromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyoscinbutylbromide EP), Hyoscinbutylbromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyoscinbutylbromide USP).
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