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Looking for 99755-59-6 / Rotigotine API manufacturers, exporters & distributors?

Rotigotine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rotigotine

Synonyms

99755-59-6, Neupro, Leganto, Spm 962, (s)-6-(propyl(2-(thiophen-2-yl)ethyl)amino)-5,6,7,8-tetrahydronaphthalen-1-ol, Spm-962

Cas Number

99755-59-6

Unique Ingredient Identifier (UNII)

87T4T8BO2E

About Rotigotine

Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.

Cyclopentylcytosine Manufacturers

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

Cyclopentylcytosine Suppliers

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

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

Cyclopentylcytosine USDMF

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

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

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

Cyclopentylcytosine CEP

A Cyclopentylcytosine CEP of the European Pharmacopoeia monograph is often referred to as a Cyclopentylcytosine Certificate of Suitability (COS). The purpose of a Cyclopentylcytosine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cyclopentylcytosine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cyclopentylcytosine to their clients by showing that a Cyclopentylcytosine CEP has been issued for it. The manufacturer submits a Cyclopentylcytosine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cyclopentylcytosine CEP holder for the record. Additionally, the data presented in the Cyclopentylcytosine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cyclopentylcytosine DMF.

A Cyclopentylcytosine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cyclopentylcytosine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Cyclopentylcytosine suppliers with CEP (COS) on PharmaCompass.

Cyclopentylcytosine WC

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

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

Cyclopentylcytosine 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 Cyclopentylcytosine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cyclopentylcytosine 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 Cyclopentylcytosine 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 Cyclopentylcytosine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cyclopentylcytosine NDC to their finished compounded human drug products, they may choose to do so.

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

Cyclopentylcytosine GMP

Cyclopentylcytosine 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 Cyclopentylcytosine 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 Cyclopentylcytosine GMP manufacturer or Cyclopentylcytosine GMP API supplier for your needs.

Cyclopentylcytosine CoA

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

Cyclopentylcytosine CoA mostly includes findings from lab analyses of a specific batch. For each Cyclopentylcytosine 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.

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