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

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01 Metrochem API Private Limited (2)

02 Alembic Pharmaceuticals Limited (1)

03 Apotex Pharmachem (1)

04 Chromo Laboratories (1)

05 Dipharma (4)

06 Hetero Drugs (2)

07 Jubilant Generics (1)

08 Lee Pharma (1)

09 Lupin Ltd (1)

10 MSN Laboratories (2)

11 Optimus Pharma (1)

12 Orchid Pharma (1)

13 Piramal Pharma Solutions (1)

14 Raks Pharma (2)

15 Viatris (2)

16 Waterstone Pharmaceuticals Inc. (1)

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01 DEXLANSOPRAZOLE (10)

02 DEXLANSOPRAZOLE (DXJ) (1)

03 DEXLANSOPRAZOLE (ROUTE CODE - DR) (1)

04 DEXLANSOPRAZOLE AMORPHOUS (2)

05 DEXLANSOPRAZOLE ANHYDRATE (1)

06 DEXLANSOPRAZOLE ANHYDROUS (2)

07 DEXLANSOPRAZOLE ANHYDROUS [ROUTE CODE - "DZ"] (1)

08 DEXLANSOPRAZOLE API (1)

09 DEXLANSOPRAZOLE SESQUIHYDRATE (4)

10 DEXLANSOPRAZOLE SESQUIHYDRATE [ROUTE CODE - "DP"] (1)

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01 Canada (1)

02 China (1)

03 India (15)

04 Italy (4)

05 U.S.A (3)

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01 Active (19)

02 Inactive (5)

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01 Complete (10)

02 Blank (14)

URL Supplier Web Content
29035
Active
2015-03-30
Complete
2015-06-11
2015-03-19
II
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URL Supplier Web Content
28052
Active
2014-03-28
N/A
II
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URL Supplier Web Content
24815
Active
2011-04-01
Complete
2016-09-20
2016-07-01
II
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URL Supplier Web Content
23722
Active
2010-04-19
N/A
II
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URL Supplier Web Content
25235
Active
2011-08-31
N/A
II
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URL Supplier Web Content
30084
Active
2016-05-13
Complete
2016-07-06
2016-05-06
II
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URL Supplier Web Content
26087
Active
2012-05-23
N/A
II
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URL Supplier Web Content
24503
Active
2010-12-21
Complete
2013-03-22
2012-11-23
II
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Looking for 138530-94-6 / Dexlansoprazole API manufacturers, exporters & distributors?

Dexlansoprazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dexlansoprazole

Synonyms

(r)-lansoprazole, 138530-94-6, Kapidex, R-(+)-lansoprazole, Dexilant, Dexilant solutab

Cas Number

138530-94-6

Unique Ingredient Identifier (UNII)

UYE4T5I70X

About Dexlansoprazole

The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.

Dexlansoprazole Manufacturers

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

Dexlansoprazole Suppliers

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

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

Dexlansoprazole USDMF

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

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

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

Dexlansoprazole Manufacturers | Traders | Suppliers

Dexlansoprazole 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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