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