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  • TABLET;ORAL - EQ 100MG BASE
  • TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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Looking for 111974-72-2 / Quetiapine Fumarate API manufacturers, exporters & distributors?

Quetiapine Fumarate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Quetiapine Fumarate 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 Quetiapine Fumarate manufacturer or Quetiapine Fumarate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quetiapine Fumarate manufacturer or Quetiapine Fumarate supplier.

PharmaCompass also assists you with knowing the Quetiapine Fumarate API Price utilized in the formulation of products. Quetiapine Fumarate API Price is not always fixed or binding as the Quetiapine Fumarate Price is obtained through a variety of data sources. The Quetiapine Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Quetiapine Fumarate

Synonyms

Quetiapine hemifumarate, 111974-72-2, Seroquel, Ici-204636, Seroquel xr, Ici 204,636

Cas Number

111974-72-2

Unique Ingredient Identifier (UNII)

2S3PL1B6UJ

About Quetiapine Fumarate

A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.

Quetiapine Hemifumarate Manufacturers

A Quetiapine Hemifumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quetiapine Hemifumarate, including repackagers and relabelers. The FDA regulates Quetiapine Hemifumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quetiapine Hemifumarate 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 Quetiapine Hemifumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Quetiapine Hemifumarate Suppliers

A Quetiapine Hemifumarate supplier is an individual or a company that provides Quetiapine Hemifumarate active pharmaceutical ingredient (API) or Quetiapine Hemifumarate finished formulations upon request. The Quetiapine Hemifumarate suppliers may include Quetiapine Hemifumarate API manufacturers, exporters, distributors and traders.

click here to find a list of Quetiapine Hemifumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Quetiapine Hemifumarate USDMF

A Quetiapine Hemifumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quetiapine Hemifumarate active pharmaceutical ingredient (API) in detail. Different forms of Quetiapine Hemifumarate DMFs exist exist since differing nations have different regulations, such as Quetiapine Hemifumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Quetiapine Hemifumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Quetiapine Hemifumarate USDMF includes data on Quetiapine Hemifumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quetiapine Hemifumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Quetiapine Hemifumarate suppliers with USDMF on PharmaCompass.

Quetiapine Hemifumarate JDMF

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 Quetiapine Hemifumarate Drug Master File in Japan (Quetiapine Hemifumarate JDMF) empowers Quetiapine Hemifumarate 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 Quetiapine Hemifumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Quetiapine Hemifumarate 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 Quetiapine Hemifumarate suppliers with JDMF on PharmaCompass.

Quetiapine Hemifumarate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Quetiapine Hemifumarate Drug Master File in Korea (Quetiapine Hemifumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Quetiapine Hemifumarate. The MFDS reviews the Quetiapine Hemifumarate KDMF as part of the drug registration process and uses the information provided in the Quetiapine Hemifumarate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Quetiapine Hemifumarate 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 Quetiapine Hemifumarate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Quetiapine Hemifumarate suppliers with KDMF on PharmaCompass.

Quetiapine Hemifumarate CEP

A Quetiapine Hemifumarate CEP of the European Pharmacopoeia monograph is often referred to as a Quetiapine Hemifumarate Certificate of Suitability (COS). The purpose of a Quetiapine Hemifumarate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Quetiapine Hemifumarate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Quetiapine Hemifumarate to their clients by showing that a Quetiapine Hemifumarate CEP has been issued for it. The manufacturer submits a Quetiapine Hemifumarate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Quetiapine Hemifumarate CEP holder for the record. Additionally, the data presented in the Quetiapine Hemifumarate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Quetiapine Hemifumarate DMF.

A Quetiapine Hemifumarate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Quetiapine Hemifumarate 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 Quetiapine Hemifumarate suppliers with CEP (COS) on PharmaCompass.

Quetiapine Hemifumarate WC

A Quetiapine Hemifumarate written confirmation (Quetiapine Hemifumarate WC) is an official document issued by a regulatory agency to a Quetiapine Hemifumarate manufacturer, verifying that the manufacturing facility of a Quetiapine Hemifumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Quetiapine Hemifumarate APIs or Quetiapine Hemifumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Quetiapine Hemifumarate WC (written confirmation) as part of the regulatory process.

click here to find a list of Quetiapine Hemifumarate suppliers with Written Confirmation (WC) on PharmaCompass.

Quetiapine Hemifumarate NDC

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 Quetiapine Hemifumarate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Quetiapine Hemifumarate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Quetiapine Hemifumarate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Quetiapine Hemifumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Quetiapine Hemifumarate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Quetiapine Hemifumarate suppliers with NDC on PharmaCompass.

Quetiapine Hemifumarate GMP

Quetiapine Hemifumarate 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 Quetiapine Hemifumarate 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 Quetiapine Hemifumarate GMP manufacturer or Quetiapine Hemifumarate GMP API supplier for your needs.

Quetiapine Hemifumarate CoA

A Quetiapine Hemifumarate CoA (Certificate of Analysis) is a formal document that attests to Quetiapine Hemifumarate's compliance with Quetiapine Hemifumarate specifications and serves as a tool for batch-level quality control.

Quetiapine Hemifumarate CoA mostly includes findings from lab analyses of a specific batch. For each Quetiapine Hemifumarate 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.

Quetiapine Hemifumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Quetiapine Hemifumarate EP), Quetiapine Hemifumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quetiapine Hemifumarate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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