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

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Samo Pharmaceutical Co., Ltd.
2019-10-21
20191021-209-J-391
Amino Chemicals Ltd
Malta
MRA 050X industrial Estat...
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Samo Pharmaceutical Co., Ltd.
2020-12-17
20201217-209-J-786
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Korea Biochem Pharmaceutical Co., Ltd.
2019-01-11
20190111-209-J-301
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Takeda Pharmaceutical Korea Co., Ltd.
2022-02-08
20220208-209-J-1231
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2020-09-22
20200922-209-J-497
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20171024-209-J-174
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20171024-209-J-174(1)
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  • CAPSULE, DELAYED RELEASE;ORAL - 30MG
  • CAPSULE, DELAYED RELEASE;ORAL - 60MG

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 KDMF

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

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

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

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

Dexlansoprazole Manufacturers | Traders | Suppliers

Dexlansoprazole Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Dexlansoprazole

Get in contact with the supplier of your choice:

  1. Amino Chemicals
  2. Korea Biochem Pharm
  3. SPC Research Institute
  4. Takeda Pharmaceutical
  5. Viatris
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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