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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.
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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 Butylhyoscine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butylhyoscine, including repackagers and relabelers. The FDA regulates Butylhyoscine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butylhyoscine 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 Butylhyoscine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butylhyoscine supplier is an individual or a company that provides Butylhyoscine active pharmaceutical ingredient (API) or Butylhyoscine finished formulations upon request. The Butylhyoscine suppliers may include Butylhyoscine API manufacturers, exporters, distributors and traders.
click here to find a list of Butylhyoscine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butylhyoscine DMF (Drug Master File) is a document detailing the whole manufacturing process of Butylhyoscine active pharmaceutical ingredient (API) in detail. Different forms of Butylhyoscine DMFs exist exist since differing nations have different regulations, such as Butylhyoscine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butylhyoscine DMF submitted to regulatory agencies in the US is known as a USDMF. Butylhyoscine USDMF includes data on Butylhyoscine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butylhyoscine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butylhyoscine 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 Butylhyoscine Drug Master File in Japan (Butylhyoscine JDMF) empowers Butylhyoscine 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 Butylhyoscine JDMF during the approval evaluation for pharmaceutical products. At the time of Butylhyoscine 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 Butylhyoscine 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 Butylhyoscine Drug Master File in Korea (Butylhyoscine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Butylhyoscine. The MFDS reviews the Butylhyoscine KDMF as part of the drug registration process and uses the information provided in the Butylhyoscine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Butylhyoscine 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 Butylhyoscine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Butylhyoscine suppliers with KDMF on PharmaCompass.
A Butylhyoscine CEP of the European Pharmacopoeia monograph is often referred to as a Butylhyoscine Certificate of Suitability (COS). The purpose of a Butylhyoscine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Butylhyoscine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Butylhyoscine to their clients by showing that a Butylhyoscine CEP has been issued for it. The manufacturer submits a Butylhyoscine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Butylhyoscine CEP holder for the record. Additionally, the data presented in the Butylhyoscine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Butylhyoscine DMF.
A Butylhyoscine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Butylhyoscine 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 Butylhyoscine suppliers with CEP (COS) on PharmaCompass.
A Butylhyoscine written confirmation (Butylhyoscine WC) is an official document issued by a regulatory agency to a Butylhyoscine manufacturer, verifying that the manufacturing facility of a Butylhyoscine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Butylhyoscine APIs or Butylhyoscine finished pharmaceutical products to another nation, regulatory agencies frequently require a Butylhyoscine WC (written confirmation) as part of the regulatory process.
click here to find a list of Butylhyoscine 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 Butylhyoscine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Butylhyoscine 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 Butylhyoscine 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 Butylhyoscine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Butylhyoscine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Butylhyoscine suppliers with NDC on PharmaCompass.
Butylhyoscine 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 Butylhyoscine 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 Butylhyoscine GMP manufacturer or Butylhyoscine GMP API supplier for your needs.
A Butylhyoscine CoA (Certificate of Analysis) is a formal document that attests to Butylhyoscine's compliance with Butylhyoscine specifications and serves as a tool for batch-level quality control.
Butylhyoscine CoA mostly includes findings from lab analyses of a specific batch. For each Butylhyoscine 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.
Butylhyoscine may be tested according to a variety of international standards, such as European Pharmacopoeia (Butylhyoscine EP), Butylhyoscine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Butylhyoscine USP).
