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

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01 Dr. Reddy's Laboratories Ltd. (1)

02 Hetero Labs Limited (1)

03 Shilpa Pharma Lifesciences Limited (1)

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01 Azacitidine (2)

02 Azacitidine "D" (1)

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01 India (3)

URL Supplier Web Content
301MF10047
7-2-A2,Hetero Corporate,Industrial ...
2019-08-20
2019-08-20
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URL Supplier Web Content
303MF10033
Shilpa House, #12-6-214/A1, Hyderab...
2021-11-02
2021-02-16
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Looking for 320-67-2 / Azacitidine API manufacturers, exporters & distributors?

Azacitidine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Azacitidine

Synonyms

5-azacytidine, 320-67-2, Azacytidine, Ladakamycin, Vidaza, Mylosar

Cas Number

320-67-2

Unique Ingredient Identifier (UNII)

M801H13NRU

About Azacitidine

A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.

Azacitidine Manufacturers

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

Azacitidine Suppliers

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

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

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

Azacitidine Manufacturers | Traders | Suppliers

Azacitidine Manufacturers, Traders, Suppliers 1
10

We have 3 companies offering Azacitidine

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. Hetero Drugs
  3. Shilpa Medicare
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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