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

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Iksoo Pharmaceutical Co., Ltd.
2023-01-27
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Chirogate International I...
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  • CAPSULE;ORAL - 24MCG
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Looking for 333963-40-9 / Lubiprostone API manufacturers, exporters & distributors?

Lubiprostone manufacturers, exporters & distributors 1

52

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

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

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

API | Excipient name

Lubiprostone

Synonyms

Amitiza, 333963-40-9, 136790-76-6, Ru-0211, Spi-0211, (2r,4ar,5r,7ar)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxo-3,4,4a,5,7,7a-hexahydrocyclopenta[b]pyran-5-heptanoic acid

Cas Number

333963-40-9

Unique Ingredient Identifier (UNII)

7662KG2R6K

About Lubiprostone

Member of a bicyclic fatty acid class of compounds derived from PROSTAGLANDIN E1 involved in chloride channel gating.

Lubiprostone Manufacturers

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

Lubiprostone Suppliers

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

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

Lubiprostone KDMF

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

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

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

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

Lubiprostone Manufacturers | Traders | Suppliers

Lubiprostone Manufacturers, Traders, Suppliers 1
37

We have 3 companies offering Lubiprostone

Get in contact with the supplier of your choice:

  1. Chirogate International
  2. Everlight Chemical
  3. Sucampo Pharmaceuticals, Inc.
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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