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List of Drug Master Files (JDMF) for Asenapine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Aspen Oss B. V. (1)

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01 Asenapine maleate (1)

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01 Netherlands (1)

227MF10107
Kloosterstraat 6, 5349 AB Oss, the ...
2020-11-30
2015-04-09

Looking for 85650-56-2 / Asenapine Maleate API manufacturers, exporters & distributors?

Asenapine Maleate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Asenapine Maleate

Synonyms

85650-56-2, Asenapine (maleate), Sycrest, Asenapine maleate [usan], Org 5222, Org-5222

Cas Number

85650-56-2

Unique Ingredient Identifier (UNII)

CU9463U2E2

Asenapine Manufacturers

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

Asenapine Suppliers

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

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

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

Asenapine Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Aspen API
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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