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

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Looking for 91374-21-9 / Ropinirole API manufacturers, exporters & distributors?

Ropinirole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ropinirole

Synonyms

91374-21-9, Ropinirol, Ropinirolum, Ropinirolum [inn-latin], Ropinirol [inn-spanish], 4-(2-(dipropylamino)ethyl)indolin-2-one

Cas Number

91374-21-9

Unique Ingredient Identifier (UNII)

030PYR8953

About Ropinirole

Ropinirole, also known as ReQuip, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome,. It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome. In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole.

Ropinirole Manufacturers

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

Ropinirole Suppliers

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

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

Ropinirole USDMF

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

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

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

Ropinirole Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Neuland 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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