Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
NDC 
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 Global Life Sciences - 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.
CA, ASMF
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USDMF
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7453
Submission : 1988-04-28
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-11-28
DMF Number : 7340
Submission : 1988-02-17
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Loperamid Zentiva
Dosage Form : Kaps
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Loperamid Zentiva
Dosage Form : Kaps
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
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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EUROAPI
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Coating Systems & Additives
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Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
30
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 Lopemid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lopemid, including repackagers and relabelers. The FDA regulates Lopemid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lopemid 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 Lopemid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lopemid supplier is an individual or a company that provides Lopemid active pharmaceutical ingredient (API) or Lopemid finished formulations upon request. The Lopemid suppliers may include Lopemid API manufacturers, exporters, distributors and traders.
click here to find a list of Lopemid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lopemid DMF (Drug Master File) is a document detailing the whole manufacturing process of Lopemid active pharmaceutical ingredient (API) in detail. Different forms of Lopemid DMFs exist exist since differing nations have different regulations, such as Lopemid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lopemid DMF submitted to regulatory agencies in the US is known as a USDMF. Lopemid USDMF includes data on Lopemid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lopemid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lopemid 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 Lopemid Drug Master File in Japan (Lopemid JDMF) empowers Lopemid 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 Lopemid JDMF during the approval evaluation for pharmaceutical products. At the time of Lopemid 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 Lopemid 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 Lopemid Drug Master File in Korea (Lopemid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lopemid. The MFDS reviews the Lopemid KDMF as part of the drug registration process and uses the information provided in the Lopemid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lopemid 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 Lopemid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lopemid suppliers with KDMF on PharmaCompass.
A Lopemid CEP of the European Pharmacopoeia monograph is often referred to as a Lopemid Certificate of Suitability (COS). The purpose of a Lopemid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lopemid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lopemid to their clients by showing that a Lopemid CEP has been issued for it. The manufacturer submits a Lopemid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lopemid CEP holder for the record. Additionally, the data presented in the Lopemid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lopemid DMF.
A Lopemid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lopemid 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 Lopemid suppliers with CEP (COS) on PharmaCompass.
A Lopemid written confirmation (Lopemid WC) is an official document issued by a regulatory agency to a Lopemid manufacturer, verifying that the manufacturing facility of a Lopemid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lopemid APIs or Lopemid finished pharmaceutical products to another nation, regulatory agencies frequently require a Lopemid WC (written confirmation) as part of the regulatory process.
click here to find a list of Lopemid 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 Lopemid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lopemid 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 Lopemid 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 Lopemid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lopemid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lopemid suppliers with NDC on PharmaCompass.
Lopemid 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 Lopemid 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 Lopemid GMP manufacturer or Lopemid GMP API supplier for your needs.
A Lopemid CoA (Certificate of Analysis) is a formal document that attests to Lopemid's compliance with Lopemid specifications and serves as a tool for batch-level quality control.
Lopemid CoA mostly includes findings from lab analyses of a specific batch. For each Lopemid 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.
Lopemid may be tested according to a variety of international standards, such as European Pharmacopoeia (Lopemid EP), Lopemid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lopemid USP).
