Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
EU-WC
Inke S.A: APIs manufacturing plant.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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USDMF
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Certificate Number : CEP 2023-059 - Rev 00
Status : Valid
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2124
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Date of Issue : 2024-12-09
Valid Till : 2027-02-26
Written Confirmation Number : WC-0494
Address of the Firm : Unit-1, Sy. No.29, Tupakulagudem (Village), Pochavaram Panchayat, Tallapudi (Man...
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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, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
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 the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
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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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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 19658
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG
USFDA APPLICATION NUMBER - 19670
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG
USFDA APPLICATION NUMBER - 20470
DOSAGE - SYRUP;ORAL - 1MG/ML
USFDA APPLICATION NUMBER - 20641
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG
USFDA APPLICATION NUMBER - 20704
DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21952
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ABOUT THIS PAGE
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PharmaCompass offers a list of Loratadine 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 Loratadine manufacturer or Loratadine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loratadine manufacturer or Loratadine supplier.
PharmaCompass also assists you with knowing the Loratadine API Price utilized in the formulation of products. Loratadine API Price is not always fixed or binding as the Loratadine Price is obtained through a variety of data sources. The Loratadine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lorfast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorfast, including repackagers and relabelers. The FDA regulates Lorfast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorfast 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 Lorfast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lorfast supplier is an individual or a company that provides Lorfast active pharmaceutical ingredient (API) or Lorfast finished formulations upon request. The Lorfast suppliers may include Lorfast API manufacturers, exporters, distributors and traders.
click here to find a list of Lorfast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lorfast DMF (Drug Master File) is a document detailing the whole manufacturing process of Lorfast active pharmaceutical ingredient (API) in detail. Different forms of Lorfast DMFs exist exist since differing nations have different regulations, such as Lorfast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lorfast DMF submitted to regulatory agencies in the US is known as a USDMF. Lorfast USDMF includes data on Lorfast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lorfast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lorfast 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 Lorfast Drug Master File in Japan (Lorfast JDMF) empowers Lorfast 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 Lorfast JDMF during the approval evaluation for pharmaceutical products. At the time of Lorfast 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 Lorfast 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 Lorfast Drug Master File in Korea (Lorfast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lorfast. The MFDS reviews the Lorfast KDMF as part of the drug registration process and uses the information provided in the Lorfast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lorfast 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 Lorfast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lorfast suppliers with KDMF on PharmaCompass.
A Lorfast CEP of the European Pharmacopoeia monograph is often referred to as a Lorfast Certificate of Suitability (COS). The purpose of a Lorfast CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lorfast EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lorfast to their clients by showing that a Lorfast CEP has been issued for it. The manufacturer submits a Lorfast CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lorfast CEP holder for the record. Additionally, the data presented in the Lorfast CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lorfast DMF.
A Lorfast CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lorfast 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 Lorfast suppliers with CEP (COS) on PharmaCompass.
A Lorfast written confirmation (Lorfast WC) is an official document issued by a regulatory agency to a Lorfast manufacturer, verifying that the manufacturing facility of a Lorfast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lorfast APIs or Lorfast finished pharmaceutical products to another nation, regulatory agencies frequently require a Lorfast WC (written confirmation) as part of the regulatory process.
click here to find a list of Lorfast 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 Lorfast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lorfast 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 Lorfast 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 Lorfast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lorfast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lorfast suppliers with NDC on PharmaCompass.
Lorfast 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 Lorfast 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 Lorfast GMP manufacturer or Lorfast GMP API supplier for your needs.
A Lorfast CoA (Certificate of Analysis) is a formal document that attests to Lorfast's compliance with Lorfast specifications and serves as a tool for batch-level quality control.
Lorfast CoA mostly includes findings from lab analyses of a specific batch. For each Lorfast 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.
Lorfast may be tested according to a variety of international standards, such as European Pharmacopoeia (Lorfast EP), Lorfast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lorfast USP).
