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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.

030PYR8953 Manufacturers

A 030PYR8953 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 030PYR8953, including repackagers and relabelers. The FDA regulates 030PYR8953 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 030PYR8953 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 030PYR8953 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

030PYR8953 Suppliers

A 030PYR8953 supplier is an individual or a company that provides 030PYR8953 active pharmaceutical ingredient (API) or 030PYR8953 finished formulations upon request. The 030PYR8953 suppliers may include 030PYR8953 API manufacturers, exporters, distributors and traders.

click here to find a list of 030PYR8953 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

030PYR8953 USDMF

A 030PYR8953 DMF (Drug Master File) is a document detailing the whole manufacturing process of 030PYR8953 active pharmaceutical ingredient (API) in detail. Different forms of 030PYR8953 DMFs exist exist since differing nations have different regulations, such as 030PYR8953 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 030PYR8953 DMF submitted to regulatory agencies in the US is known as a USDMF. 030PYR8953 USDMF includes data on 030PYR8953's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 030PYR8953 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 030PYR8953 suppliers with USDMF on PharmaCompass.

030PYR8953 WC

A 030PYR8953 written confirmation (030PYR8953 WC) is an official document issued by a regulatory agency to a 030PYR8953 manufacturer, verifying that the manufacturing facility of a 030PYR8953 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 030PYR8953 APIs or 030PYR8953 finished pharmaceutical products to another nation, regulatory agencies frequently require a 030PYR8953 WC (written confirmation) as part of the regulatory process.

click here to find a list of 030PYR8953 suppliers with Written Confirmation (WC) on PharmaCompass.

030PYR8953 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 030PYR8953 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 030PYR8953 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 030PYR8953 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 030PYR8953 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 030PYR8953 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 030PYR8953 suppliers with NDC on PharmaCompass.

030PYR8953 GMP

030PYR8953 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of 030PYR8953 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 030PYR8953 GMP manufacturer or 030PYR8953 GMP API supplier for your needs.

030PYR8953 CoA

A 030PYR8953 CoA (Certificate of Analysis) is a formal document that attests to 030PYR8953's compliance with 030PYR8953 specifications and serves as a tool for batch-level quality control.

030PYR8953 CoA mostly includes findings from lab analyses of a specific batch. For each 030PYR8953 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

030PYR8953 may be tested according to a variety of international standards, such as European Pharmacopoeia (030PYR8953 EP), 030PYR8953 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (030PYR8953 USP).

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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