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List of Japan Drug Master File (JDMF) for Ropinirole Hydrochloride Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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  • TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Ropinirole Hydrochloride Drug Master File in Japan (Ropinirole Hydrochloride JDMF) empowers Ropinirole Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Ropinirole Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ropinirole Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Ropinirole Hydrochloride suppliers with JDMF 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. Alembic Pharmaceuticals Limited
  2. Glenmark Life Sciences
  3. Ind Swift Laboratories Limited
  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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