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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 produces high-quality plant-based active ingredients for the pharmaceutical, cosmetic, and nutraceutical indu...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
About the Company : Phytex Australia specializes in the contract manufacturing of APIs from natural resources, serving global pharmaceutical and research sectors. From R&D to commercial production, we...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
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EUROAPI
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
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PharmaCompass offers a list of Scopolamine Hydrobromide 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 Scopolamine Hydrobromide manufacturer or Scopolamine Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Scopolamine Hydrobromide manufacturer or Scopolamine Hydrobromide supplier.
PharmaCompass also assists you with knowing the Scopolamine Hydrobromide API Price utilized in the formulation of products. Scopolamine Hydrobromide API Price is not always fixed or binding as the Scopolamine Hydrobromide Price is obtained through a variety of data sources. The Scopolamine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Scopolamine Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Scopolamine Hydrobromide, including repackagers and relabelers. The FDA regulates Scopolamine Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Scopolamine Hydrobromide 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 Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Scopolamine Hydrobromide supplier is an individual or a company that provides Scopolamine Hydrobromide active pharmaceutical ingredient (API) or Scopolamine Hydrobromide finished formulations upon request. The Scopolamine Hydrobromide suppliers may include Scopolamine Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Scopolamine Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Scopolamine Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Scopolamine Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Scopolamine Hydrobromide DMFs exist exist since differing nations have different regulations, such as Scopolamine Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Scopolamine Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Scopolamine Hydrobromide USDMF includes data on Scopolamine Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Scopolamine Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Scopolamine Hydrobromide 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 Scopolamine Hydrobromide Drug Master File in Japan (Scopolamine Hydrobromide JDMF) empowers Scopolamine Hydrobromide 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 Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Scopolamine Hydrobromide 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 Hydrobromide 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 Hydrobromide Drug Master File in Korea (Scopolamine Hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Scopolamine Hydrobromide. The MFDS reviews the Scopolamine Hydrobromide KDMF as part of the drug registration process and uses the information provided in the Scopolamine Hydrobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Scopolamine Hydrobromide 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 Hydrobromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Scopolamine Hydrobromide suppliers with KDMF on PharmaCompass.
A Scopolamine Hydrobromide CEP of the European Pharmacopoeia monograph is often referred to as a Scopolamine Hydrobromide Certificate of Suitability (COS). The purpose of a Scopolamine Hydrobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Scopolamine Hydrobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Scopolamine Hydrobromide to their clients by showing that a Scopolamine Hydrobromide CEP has been issued for it. The manufacturer submits a Scopolamine Hydrobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Scopolamine Hydrobromide CEP holder for the record. Additionally, the data presented in the Scopolamine Hydrobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Scopolamine Hydrobromide DMF.
A Scopolamine Hydrobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Scopolamine Hydrobromide 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 Hydrobromide suppliers with CEP (COS) on PharmaCompass.
A Scopolamine Hydrobromide written confirmation (Scopolamine Hydrobromide WC) is an official document issued by a regulatory agency to a Scopolamine Hydrobromide manufacturer, verifying that the manufacturing facility of a Scopolamine Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Scopolamine Hydrobromide APIs or Scopolamine Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Scopolamine Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Scopolamine Hydrobromide 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 Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Scopolamine Hydrobromide 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 Hydrobromide 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 Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Scopolamine Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Scopolamine Hydrobromide suppliers with NDC on PharmaCompass.
Scopolamine Hydrobromide 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 Hydrobromide 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 Scopolamine Hydrobromide GMP manufacturer or Scopolamine Hydrobromide GMP API supplier for your needs.
A Scopolamine Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Scopolamine Hydrobromide's compliance with Scopolamine Hydrobromide specifications and serves as a tool for batch-level quality control.
Scopolamine Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Scopolamine Hydrobromide 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 Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Scopolamine Hydrobromide EP), Scopolamine Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Scopolamine Hydrobromide USP).
