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