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List of Drug Master Files (DMF) of Lubiprostone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (1)

02 Apotex Pharmachem (2)

03 Catalent Pharma Solutions (1)

04 Everlight Chemical (1)

05 MSN Laboratories (1)

06 PHF SA (1)

07 R TECH UENO LTD (1)

08 Sun Pharmaceutical Industries Limited (1)

09 Teva API (1)

10 Yonsung Fine Chemicals (1)

11 Zhejiang Ausun Pharmaceutical (1)

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01 LUBIPROSTONE (10)

02 LUBIPROSTONE (RU-0211) (1)

03 LUBIPROSTONE, 24 MCG CAPSULES (1)

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01 Canada (2)

02 China (1)

03 India (3)

04 Israel (1)

05 Japan (1)

06 South Korea (1)

07 Switzerland (1)

08 Taiwan (1)

09 U.S.A (1)

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01 Active (8)

02 Inactive (4)

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01 Complete (5)

02 Blank (7)

URL Supplier Web Content
31275
Active
2017-01-31
Complete
2018-04-27
2018-03-29
II
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URL Supplier Web Content
18076
Inactive
2005-02-11
N/A
II
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URL Supplier Web Content
23383
Active
2009-12-17
Complete
2014-06-05
2014-05-29
II
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URL Supplier Web Content
34416
Active
2019-12-31
N/A
II
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URL Supplier Web Content
18091
Active
2005-02-18
N/A
II
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URL Supplier Web Content
32472
Active
2018-03-30
Complete
2018-04-27
2018-02-09
II
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URL Supplier Web Content
23402
Inactive
2009-12-23
N/A
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URL Supplier Web Content
37281
Active
2022-08-24
N/A
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URL Supplier Web Content
30802
Active
2016-08-08
Complete
2016-10-06
2016-08-16
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Looking for 333963-40-9 / Lubiprostone API manufacturers, exporters & distributors?

Lubiprostone manufacturers, exporters & distributors 1

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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 USDMF

A Lubiprostone DMF (Drug Master File) is a document detailing the whole manufacturing process of Lubiprostone active pharmaceutical ingredient (API) in detail. Different forms of Lubiprostone DMFs exist exist since differing nations have different regulations, such as Lubiprostone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lubiprostone DMF submitted to regulatory agencies in the US is known as a USDMF. Lubiprostone USDMF includes data on Lubiprostone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lubiprostone USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

Lubiprostone Manufacturers | Traders | Suppliers

Lubiprostone Manufacturers, Traders, Suppliers 1
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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