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

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Samil Pharmaceutical Co., Ltd.
2019-04-11
20181008-209-J-125(1)
Amino Chemicals Ltd.
Malta
MRA 050X Marsa Industrial...
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Samo Pharmaceutical Co., Ltd.
2018-10-08
20181008-209-J-125
Amino Chemicals Ltd.
Malta
MRA 050X Marsa Industrial...
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Aging Life Science Co., Ltd.
2020-03-25
20200107-209-J-314(1)
Aurobindo Pharma Limited ...
India
Sy. No.10 & 13, Gaddapoth...
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Seongui Bio Co., Ltd.
2020-01-07
20200107-209-J-314
Aurobindo Pharma Limited ...
India
Sy. No.10 & 13, Gaddapoth...
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Hwanin Pharmaceutical Co., Ltd.
2020-05-04
20200107-209-J-314(2)
Aurobindo Pharma Limited ...
India
Sy. No.10 & 13, Gaddapoth...
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Sungwoo Chemical Co., Ltd.
2020-12-08
20200107-209-J-314(3)
Aurobindo Pharma Limited ...
India
Sy. No.10 & 13, Gaddapoth...
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Boehringer Ingelheim Korea Co., Ltd.
2022-05-17
20220517-209-J-1298
Boehringer Ingelheim Phar...
Germany
Binger Strasse 173, 55216...
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Leesung International Co., Ltd.
2022-05-13
20220513-209-J-1290
Hetero Drugs Limited Unit...
India
Survey. No's 213, 214 and...
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Leaders Bio Co., Ltd.
2020-07-21
20200721-209-J-381
Macleods Pharmaceuticals ...
India
Plot No. 2209, GIDC Indus...
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Lihu Healthcare Co., Ltd.
2020-01-30
20200130-209-J-481
MSN Laboratories Private ...
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Sy. No. 317 & 323, Rudrar...
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  • TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 191217-81-9 / Pramipexole API manufacturers, exporters & distributors?

Pramipexole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pramipexole

Synonyms

191217-81-9, Mirapex, (s)-n6-propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride hydrate, Pramipexole 2hcl monohydrate, Pramipexole hydrochloride, Sifrol

Cas Number

191217-81-9

Unique Ingredient Identifier (UNII)

3D867NP06J

About Pramipexole

A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.

Pramipexole Dihydrochloride Manufacturers

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

Pramipexole Dihydrochloride Suppliers

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

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

Pramipexole Dihydrochloride KDMF

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

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

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

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

Pramipexole Dihydrochloride Manufacturers | Traders | Suppliers

Pramipexole Dihydrochloride Manufacturers, Traders, Suppliers 1
64

We have 6 companies offering Pramipexole Dihydrochloride

Get in contact with the supplier of your choice:

  1. Amino Chemicals
  2. Aurobindo Pharma Limited
  3. Boehringer Ingelheim GmbH
  4. Hetero Drugs
  5. Macleods Pharmaceuticals Limited
  6. MSN Laboratories
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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