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List of Drug Master Files (KDMF) for Mirodenafil Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Pharmacostek Co., Ltd.@[Starting material manufacturing plant]SK Biopharmaceuticals, CMS Plant (1)

02 STech Pharma Co., Ltd. (1)

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01 Pharmacotech Co., Ltd. (1)

02 Polaris AI Pharma Co., Ltd. (1)

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01 Mirodenafil (2)

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01 South Korea (2)

URL Supplier Web Content
Polaris AI Pharma Co., Ltd.
2021-02-09
1962-7-ND
STech Pharma Co., Ltd.
South Korea
Room 10, Room 11, Block 3...
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URL Supplier Web Content
Pharmacotech Co., Ltd.
2015-08-24
2572-2-ND
Pharmacostek Co., Ltd.@[S...
South Korea
SK Biopharm CMS Plant, 47...
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Looking for 862189-95-5 / Mirodenafil API manufacturers, exporters & distributors?

Mirodenafil manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mirodenafil

Synonyms

862189-95-5, Mirodenafil [inn], Sk3530, Sk-3530, Sk3530 free base, Sk-3530 free base

Cas Number

862189-95-5

Unique Ingredient Identifier (UNII)

504G362H0H

About Mirodenafil

Mirodenafil has been used in trials studying the treatment and supportive care of Kidney Diseases, Urologic Diseases, Renal Insufficiency, Erectile Dysfunction, and Male Erectile Dysfunction.

Mirodenafil Manufacturers

A Mirodenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirodenafil, including repackagers and relabelers. The FDA regulates Mirodenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirodenafil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Mirodenafil Suppliers

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

Mirodenafil KDMF

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

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

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

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

Mirodenafil Manufacturers | Traders | Suppliers

Mirodenafil Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Mirodenafil

Get in contact with the supplier of your choice:

  1. Estechpharma
  2. Pharmacostech
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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