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API SUPPLIERS
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USDMF
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-11-24
DMF Number : 28277
Submission : 2014-05-08
Status :
Type : II
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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...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Alcaftadine 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 Alcaftadine manufacturer or Alcaftadine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alcaftadine manufacturer or Alcaftadine supplier.
PharmaCompass also assists you with knowing the Alcaftadine API Price utilized in the formulation of products. Alcaftadine API Price is not always fixed or binding as the Alcaftadine Price is obtained through a variety of data sources. The Alcaftadine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alcaftadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alcaftadine, including repackagers and relabelers. The FDA regulates Alcaftadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alcaftadine 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 Alcaftadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alcaftadine supplier is an individual or a company that provides Alcaftadine active pharmaceutical ingredient (API) or Alcaftadine finished formulations upon request. The Alcaftadine suppliers may include Alcaftadine API manufacturers, exporters, distributors and traders.
click here to find a list of Alcaftadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alcaftadine DMF (Drug Master File) is a document detailing the whole manufacturing process of Alcaftadine active pharmaceutical ingredient (API) in detail. Different forms of Alcaftadine DMFs exist exist since differing nations have different regulations, such as Alcaftadine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alcaftadine DMF submitted to regulatory agencies in the US is known as a USDMF. Alcaftadine USDMF includes data on Alcaftadine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alcaftadine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alcaftadine suppliers with USDMF 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 Alcaftadine Drug Master File in Korea (Alcaftadine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alcaftadine. The MFDS reviews the Alcaftadine KDMF as part of the drug registration process and uses the information provided in the Alcaftadine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alcaftadine 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 Alcaftadine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alcaftadine suppliers with KDMF on PharmaCompass.
A Alcaftadine written confirmation (Alcaftadine WC) is an official document issued by a regulatory agency to a Alcaftadine manufacturer, verifying that the manufacturing facility of a Alcaftadine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alcaftadine APIs or Alcaftadine finished pharmaceutical products to another nation, regulatory agencies frequently require a Alcaftadine WC (written confirmation) as part of the regulatory process.
click here to find a list of Alcaftadine 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 Alcaftadine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alcaftadine 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 Alcaftadine 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 Alcaftadine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alcaftadine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alcaftadine suppliers with NDC on PharmaCompass.
Alcaftadine 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 Alcaftadine 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 Alcaftadine GMP manufacturer or Alcaftadine GMP API supplier for your needs.
A Alcaftadine CoA (Certificate of Analysis) is a formal document that attests to Alcaftadine's compliance with Alcaftadine specifications and serves as a tool for batch-level quality control.
Alcaftadine CoA mostly includes findings from lab analyses of a specific batch. For each Alcaftadine 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.
Alcaftadine may be tested according to a variety of international standards, such as European Pharmacopoeia (Alcaftadine EP), Alcaftadine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alcaftadine USP).
