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

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01 Piramal Healthcare UK Limited (1)

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01 Misoprostol dispersion (1)

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01 Australia (1)

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303MF10170
Whalton Road, Morpeth, Northumberla...
2021-12-02
2021-12-02
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Looking for 59122-46-2 / Misoprostol API manufacturers, exporters & distributors?

Misoprostol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Misoprostol

Synonyms

59122-46-2, Cytotec, Isprelor, Sc-29333, Misoprostolum [inn-latin], Misodel

Cas Number

59122-46-2

Unique Ingredient Identifier (UNII)

0E43V0BB57

About Misoprostol

A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.

Misoprostol Manufacturers

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

Misoprostol Suppliers

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

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

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

Misoprostol Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Healius
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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