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List of Drug Master Files (KDMF) for Ropinirole Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Neuland laboratories Ltd. (Unit-I) (1)

02 Alembic Pharmaceuticals Limited (API Unit-I). (2)

03 Thermo Fisher Scientific Cork Limited (1)

04 URQUIMA S.A. (1)

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01 Aging Life Science Co., Ltd. (1)

02 GlaxoSmithKline Co., Ltd. (1)

03 Kookjeon Pharmaceutical Co., Ltd. (1)

04 Pharmapia Co., Ltd. (1)

05 Sungjin Exim Co., Ltd. (1)

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01 Ropinirole hydrochloride (5)

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01 India (3)

02 Spain (1)

03 U.S.A (1)

Aging Life Science Co., Ltd.
2020-07-07
20200707-209-J-678
Neuland laboratories Ltd....
India
Sy. No. 347, 473, 474, 49...
URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2023-10-25
20190104-209-J-175(1)
Alembic Pharmaceuticals L...
India
AT-Panelav, Tal-Halol, Ci...
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Pharmapia Co., Ltd.
2019-01-04
20190104-209-J-175
Alembic Pharmaceuticals L...
India
AT-Panelav, Tal-Halol, Ci...
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GlaxoSmithKline Co., Ltd.
2021-03-25
20210325-209-J-912
Thermo Fisher Scientific ...
Ireland
Currabinny, Carrigaline, ...
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Sungjin Exim Co., Ltd.
2019-09-06
20190906-209-J-261
URQUIMA S.A.
Spain
Arnau de vilanova 22-42 0...
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Looking for 91374-20-8 / Ropinirole Hydrochloride API manufacturers, exporters & distributors?

Ropinirole Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ropinirole Hydrochloride

Synonyms

91374-20-8, Ropinirole hcl, Requip, 4-(2-(dipropylamino)ethyl)indolin-2-one hydrochloride, Skf 101468 hydrochloride, Requip xl

Cas Number

91374-20-8

Unique Ingredient Identifier (UNII)

D7ZD41RZI9

About Ropinirole Hydrochloride

Ropinirole Hydrochloride is the hydrochloride salt form of ropinirole, a non-ergot dopamine agonist with antiparkinsonian property. Acting as a substitute for dopamine, ropinirole hydrochloride binds to and activates dopamine D2 and D3 receptors within the caudate putamen in the brain, thereby improving motor function.

Ropinirole Hydrochloride Manufacturers

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

Ropinirole Hydrochloride Suppliers

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

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

Ropinirole Hydrochloride KDMF

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

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

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

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

Ropinirole Hydrochloride Manufacturers | Traders | Suppliers

Ropinirole Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Ropinirole Hydrochloride

Get in contact with the supplier of your choice:

  1. Neuland Laboratories
  2. Alembic Pharmaceuticals Limited
  3. Thermo Fisher Scientific
  4. Urquima S.A. Grupo Uriach
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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