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USDMF
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2015-07-23
DMF Number : 12530
Submission : 1997-05-28
Status :
Type : II
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ABOUT THIS PAGE
A Haloperidol Decanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Haloperidol Decanoate, including repackagers and relabelers. The FDA regulates Haloperidol Decanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Haloperidol Decanoate 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 Haloperidol Decanoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Haloperidol Decanoate supplier is an individual or a company that provides Haloperidol Decanoate active pharmaceutical ingredient (API) or Haloperidol Decanoate finished formulations upon request. The Haloperidol Decanoate suppliers may include Haloperidol Decanoate API manufacturers, exporters, distributors and traders.
click here to find a list of Haloperidol Decanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Haloperidol Decanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Haloperidol Decanoate active pharmaceutical ingredient (API) in detail. Different forms of Haloperidol Decanoate DMFs exist exist since differing nations have different regulations, such as Haloperidol Decanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Haloperidol Decanoate DMF submitted to regulatory agencies in the US is known as a USDMF. Haloperidol Decanoate USDMF includes data on Haloperidol Decanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Haloperidol Decanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Haloperidol Decanoate suppliers with USDMF on PharmaCompass.
A Haloperidol Decanoate CEP of the European Pharmacopoeia monograph is often referred to as a Haloperidol Decanoate Certificate of Suitability (COS). The purpose of a Haloperidol Decanoate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Haloperidol Decanoate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Haloperidol Decanoate to their clients by showing that a Haloperidol Decanoate CEP has been issued for it. The manufacturer submits a Haloperidol Decanoate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Haloperidol Decanoate CEP holder for the record. Additionally, the data presented in the Haloperidol Decanoate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Haloperidol Decanoate DMF.
A Haloperidol Decanoate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Haloperidol Decanoate 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 Haloperidol Decanoate suppliers with CEP (COS) on PharmaCompass.
A Haloperidol Decanoate written confirmation (Haloperidol Decanoate WC) is an official document issued by a regulatory agency to a Haloperidol Decanoate manufacturer, verifying that the manufacturing facility of a Haloperidol Decanoate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Haloperidol Decanoate APIs or Haloperidol Decanoate finished pharmaceutical products to another nation, regulatory agencies frequently require a Haloperidol Decanoate WC (written confirmation) as part of the regulatory process.
click here to find a list of Haloperidol Decanoate 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 Haloperidol Decanoate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Haloperidol Decanoate 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 Haloperidol Decanoate 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 Haloperidol Decanoate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Haloperidol Decanoate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Haloperidol Decanoate suppliers with NDC on PharmaCompass.
Haloperidol Decanoate 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 Haloperidol Decanoate 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 Haloperidol Decanoate GMP manufacturer or Haloperidol Decanoate GMP API supplier for your needs.
A Haloperidol Decanoate CoA (Certificate of Analysis) is a formal document that attests to Haloperidol Decanoate's compliance with Haloperidol Decanoate specifications and serves as a tool for batch-level quality control.
Haloperidol Decanoate CoA mostly includes findings from lab analyses of a specific batch. For each Haloperidol Decanoate 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.
Haloperidol Decanoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Haloperidol Decanoate EP), Haloperidol Decanoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Haloperidol Decanoate USP).
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