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API SUPPLIERS
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CEP/COS
Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
Certificate Number : CEP 2017-085 - Rev 03
Status : Valid
Issue Date : 2023-10-06
Type : Chemical
Substance Number : 737
Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.
Certificate Number : CEP 2002-158 - Rev 06
Status : Valid
Issue Date : 2025-09-12
Type : Chemical
Substance Number : 737
Certificate Number : CEP 2021-397 - Rev 00
Status : Valid
Issue Date : 2023-12-12
Type : Chemical
Substance Number : 737
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Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
About the Company : With over 85 years of research-driven innovation, Alchem International manufactures high-quality plant-based active ingredients for the pharmaceutical, cosmetic, and nutraceutical ...
Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.
About the Company : Alkaloids is a trusted manufacturer of phyto-based APIs and standardized botanical extracts, with expertise dating back to 1992. With decades of experience in natural ingredient pr...
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
About the Company : Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivative...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
About the Company : Capital Farma provides integrated pharmaceutical solutions with a focus on high-quality Active Pharmaceutical Ingredients (APIs) sourced from leading European manufacturers. The co...
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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, 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.
A Scopolamine Butyl Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scopolamine Butyl Bromide, including repackagers and relabelers. The FDA regulates Scopolamine Butyl Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scopolamine Butyl 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 Scopolamine Butyl Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Scopolamine Butyl Bromide supplier is an individual or a company that provides Scopolamine Butyl Bromide active pharmaceutical ingredient (API) or Scopolamine Butyl Bromide finished formulations upon request. The Scopolamine Butyl Bromide suppliers may include Scopolamine Butyl Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Scopolamine Butyl Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information 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 Scopolamine Butyl Bromide Drug Master File in Japan (Scopolamine Butyl Bromide JDMF) empowers Scopolamine Butyl Bromide 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 Scopolamine Butyl Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Scopolamine Butyl Bromide 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 Scopolamine Butyl Bromide 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 Scopolamine Butyl Bromide Drug Master File in Korea (Scopolamine Butyl Bromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Scopolamine Butyl Bromide. The MFDS reviews the Scopolamine Butyl Bromide KDMF as part of the drug registration process and uses the information provided in the Scopolamine Butyl Bromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Scopolamine Butyl 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 Scopolamine Butyl Bromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Scopolamine Butyl Bromide suppliers with KDMF on PharmaCompass.
A Scopolamine Butyl Bromide CEP of the European Pharmacopoeia monograph is often referred to as a Scopolamine Butyl Bromide Certificate of Suitability (COS). The purpose of a Scopolamine Butyl Bromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Scopolamine Butyl Bromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Scopolamine Butyl Bromide to their clients by showing that a Scopolamine Butyl Bromide CEP has been issued for it. The manufacturer submits a Scopolamine Butyl Bromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Scopolamine Butyl Bromide CEP holder for the record. Additionally, the data presented in the Scopolamine Butyl Bromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Scopolamine Butyl Bromide DMF.
A Scopolamine Butyl Bromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Scopolamine Butyl Bromide 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 Scopolamine Butyl Bromide suppliers with CEP (COS) on PharmaCompass.
A Scopolamine Butyl Bromide written confirmation (Scopolamine Butyl Bromide WC) is an official document issued by a regulatory agency to a Scopolamine Butyl Bromide manufacturer, verifying that the manufacturing facility of a Scopolamine Butyl Bromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Scopolamine Butyl Bromide APIs or Scopolamine Butyl Bromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Scopolamine Butyl Bromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Scopolamine Butyl 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 Scopolamine Butyl Bromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Scopolamine Butyl 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 Scopolamine Butyl 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 Scopolamine Butyl Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Scopolamine Butyl Bromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Scopolamine Butyl Bromide suppliers with NDC on PharmaCompass.
Scopolamine Butyl 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 Scopolamine Butyl Bromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Scopolamine Butyl Bromide GMP manufacturer or Scopolamine Butyl Bromide GMP API supplier for your needs.
A Scopolamine Butyl Bromide CoA (Certificate of Analysis) is a formal document that attests to Scopolamine Butyl Bromide's compliance with Scopolamine Butyl Bromide specifications and serves as a tool for batch-level quality control.
Scopolamine Butyl Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Scopolamine Butyl 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.
Scopolamine Butyl Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Scopolamine Butyl Bromide EP), Scopolamine Butyl Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Scopolamine Butyl Bromide USP).
