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List of Japan Drug Master File (JDMF) for Quetiapine Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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223MF10034
Area Industrial del Llobregat, C/Ar...
2011-03-09
2011-03-09
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224MF10059
Cooppallaan 91, B-9230 Wetteren, Be...
2012-03-30
2012-03-30
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223MF10124
Viale Milano 26 36075 Montecchio Ma...
2022-09-21
2011-07-28
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228MF10094
7-2-A2,Hetero Corporate,Industrial ...
2016-04-27
2016-04-27
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2019-01-10
2015-04-21
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223MF10055
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2019-12-13
2011-04-21
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223MF10171
Unit No. 3B-38,39&40 on 3rd fl. , P...
2018-10-26
2011-12-22
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223MF10089
2-27-1 Shinkawa, Chuo-ku, Tokyo
2011-06-27
2011-06-27
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2012-05-11
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2017-07-31
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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  • TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 200MG BASE
  • TABLET;ORAL - EQ 25MG BASE
  • TABLET;ORAL - EQ 300MG BASE
  • TABLET;ORAL - EQ 400MG BASE
  • TABLET;ORAL - EQ 50MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 300MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 400MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

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 Manufacturers

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

Quetiapine Suppliers

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

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

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

Quetiapine Manufacturers | Traders | Suppliers

Quetiapine Manufacturers, Traders, Suppliers 1
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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