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EU WC
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Drugs in Development
Lead Product(s) : Ivermectin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Senores Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy's Laboratories and Senores Pharmaceuticals Launch Ivermectin Tablets in US
Details : Stromectol-Generic (ivermectin) is a glutamate-gated chloride channel modulator, small molecule drug candidate, which is indicated for the treatment of patients with strongyloidiasis & onchocerciasis.
Product Name : Stromectol-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 26, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Udderfast
Dosage Form : Cream
Dosage Strength : 10mg/g
Packaging :
Approval Date : 30-10-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Ivermectin \"Orion\"
Dosage Form : Tablet
Dosage Strength : 3mg
Packaging :
Approval Date : 25-08-2025
Application Number : 28107370725
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ivermectin Orion
Dosage Form : Tablet
Dosage Strength : 3mg
Packaging :
Approval Date : 02-09-2025
Application Number : 2.03E+13
Regulatory Info : Approved
Registration Country : Sweden
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Rosesolute
Dosage Form : Cream
Dosage Strength : 10mg/g
Packaging :
Approval Date : 30-10-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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DOSAGE - LOTION;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 202736
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 206255
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
47
PharmaCompass offers a list of Ivermectin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ivermectin manufacturer or Ivermectin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ivermectin manufacturer or Ivermectin supplier.
A Ivermectin B1a manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivermectin B1a, including repackagers and relabelers. The FDA regulates Ivermectin B1a manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivermectin B1a 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 Ivermectin B1a manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ivermectin B1a supplier is an individual or a company that provides Ivermectin B1a active pharmaceutical ingredient (API) or Ivermectin B1a finished formulations upon request. The Ivermectin B1a suppliers may include Ivermectin B1a API manufacturers, exporters, distributors and traders.
click here to find a list of Ivermectin B1a suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ivermectin B1a DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivermectin B1a active pharmaceutical ingredient (API) in detail. Different forms of Ivermectin B1a DMFs exist exist since differing nations have different regulations, such as Ivermectin B1a USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivermectin B1a DMF submitted to regulatory agencies in the US is known as a USDMF. Ivermectin B1a USDMF includes data on Ivermectin B1a's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivermectin B1a USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivermectin B1a 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 Ivermectin B1a Drug Master File in Japan (Ivermectin B1a JDMF) empowers Ivermectin B1a 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 Ivermectin B1a JDMF during the approval evaluation for pharmaceutical products. At the time of Ivermectin B1a 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 Ivermectin B1a 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 Ivermectin B1a Drug Master File in Korea (Ivermectin B1a KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ivermectin B1a. The MFDS reviews the Ivermectin B1a KDMF as part of the drug registration process and uses the information provided in the Ivermectin B1a KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ivermectin B1a 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 Ivermectin B1a API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ivermectin B1a suppliers with KDMF on PharmaCompass.
A Ivermectin B1a CEP of the European Pharmacopoeia monograph is often referred to as a Ivermectin B1a Certificate of Suitability (COS). The purpose of a Ivermectin B1a CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ivermectin B1a EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ivermectin B1a to their clients by showing that a Ivermectin B1a CEP has been issued for it. The manufacturer submits a Ivermectin B1a CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ivermectin B1a CEP holder for the record. Additionally, the data presented in the Ivermectin B1a CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ivermectin B1a DMF.
A Ivermectin B1a CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ivermectin B1a 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 Ivermectin B1a suppliers with CEP (COS) 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 Ivermectin B1a as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ivermectin B1a 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 Ivermectin B1a 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 Ivermectin B1a and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ivermectin B1a NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ivermectin B1a suppliers with NDC on PharmaCompass.
Ivermectin B1a 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 Ivermectin B1a GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ivermectin B1a GMP manufacturer or Ivermectin B1a GMP API supplier for your needs.
A Ivermectin B1a CoA (Certificate of Analysis) is a formal document that attests to Ivermectin B1a's compliance with Ivermectin B1a specifications and serves as a tool for batch-level quality control.
Ivermectin B1a CoA mostly includes findings from lab analyses of a specific batch. For each Ivermectin B1a 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.
Ivermectin B1a may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivermectin B1a EP), Ivermectin B1a JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivermectin B1a USP).
