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