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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
About the Company : PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and personal care companie...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
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...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and international markets ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic ar...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and ...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Loperamide Zentiva
Dosage Form : Capsule
Dosage Strength : 2mg
Packaging :
Approval Date : 24/10/2001
Application Number : 56049
Regulatory Info : Allowed
Registration Country : Switzerland
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DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 19860
DOSAGE - CAPSULE;ORAL - 1MG
USFDA APPLICATION NUMBER - 21855
DOSAGE - CAPSULE;ORAL - 2MG
USFDA APPLICATION NUMBER - 21855
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ABOUT THIS PAGE
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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 Dissenten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dissenten, including repackagers and relabelers. The FDA regulates Dissenten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dissenten 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 Dissenten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dissenten supplier is an individual or a company that provides Dissenten active pharmaceutical ingredient (API) or Dissenten finished formulations upon request. The Dissenten suppliers may include Dissenten API manufacturers, exporters, distributors and traders.
click here to find a list of Dissenten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dissenten DMF (Drug Master File) is a document detailing the whole manufacturing process of Dissenten active pharmaceutical ingredient (API) in detail. Different forms of Dissenten DMFs exist exist since differing nations have different regulations, such as Dissenten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dissenten DMF submitted to regulatory agencies in the US is known as a USDMF. Dissenten USDMF includes data on Dissenten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dissenten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dissenten 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 Dissenten Drug Master File in Japan (Dissenten JDMF) empowers Dissenten 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 Dissenten JDMF during the approval evaluation for pharmaceutical products. At the time of Dissenten 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 Dissenten 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 Dissenten Drug Master File in Korea (Dissenten KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dissenten. The MFDS reviews the Dissenten KDMF as part of the drug registration process and uses the information provided in the Dissenten KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dissenten 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 Dissenten API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dissenten suppliers with KDMF on PharmaCompass.
A Dissenten CEP of the European Pharmacopoeia monograph is often referred to as a Dissenten Certificate of Suitability (COS). The purpose of a Dissenten CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dissenten EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dissenten to their clients by showing that a Dissenten CEP has been issued for it. The manufacturer submits a Dissenten CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dissenten CEP holder for the record. Additionally, the data presented in the Dissenten CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dissenten DMF.
A Dissenten CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dissenten 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 Dissenten suppliers with CEP (COS) on PharmaCompass.
A Dissenten written confirmation (Dissenten WC) is an official document issued by a regulatory agency to a Dissenten manufacturer, verifying that the manufacturing facility of a Dissenten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dissenten APIs or Dissenten finished pharmaceutical products to another nation, regulatory agencies frequently require a Dissenten WC (written confirmation) as part of the regulatory process.
click here to find a list of Dissenten 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 Dissenten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dissenten 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 Dissenten 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 Dissenten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dissenten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dissenten suppliers with NDC on PharmaCompass.
Dissenten 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 Dissenten 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 Dissenten GMP manufacturer or Dissenten GMP API supplier for your needs.
A Dissenten CoA (Certificate of Analysis) is a formal document that attests to Dissenten's compliance with Dissenten specifications and serves as a tool for batch-level quality control.
Dissenten CoA mostly includes findings from lab analyses of a specific batch. For each Dissenten 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.
Dissenten may be tested according to a variety of international standards, such as European Pharmacopoeia (Dissenten EP), Dissenten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dissenten USP).
