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List of Korea Drug Master Files (KDMF) for Clozapine Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Dongwha Pharmaceutical Co., Ltd.
2018-10-23
20180903-209-J-157(1)
Medichem S.A.
Spain
Poligon Industrial de Cel...
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Sungjin Exim Co., Ltd.
2018-09-03
20180903-209-J-157
Medichem S.A.
Spain
Poligon Industrial de Cel...
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Hwanin Pharmaceutical Co., Ltd.
2020-05-04
20180903-209-J-157(2)
Medichem S.A.
Spain
Poligon Industrial de Cel...
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  • TABLET;ORAL - 100MG
  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG
  • SUSPENSION;ORAL - 50MG/ML
  • TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for / Clozapine API manufacturers, exporters & distributors?

Clozapine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Clozapine

Clozapine Manufacturers

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

Clozapine Suppliers

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

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

Clozapine KDMF

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

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

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

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

Clozapine Manufacturers | Traders | Suppliers

Clozapine Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Clozapine

Get in contact with the supplier of your choice:

  1. Medichem S.A
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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