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List of Certificates of Suitability (CEPs) for Rotigotine Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 Interquim, S.A. Sant Cugat Del Vallès ES (1)

02 WAVELENGTH ENTERPRISES LTD. Petah Tikva IL (1)

03 NEULAND LABORATORIES LIMITED Hyderabad IN (1)

04 CHENGDU EASTON BIOPHARMACEUTICALS CO., LTD. Chengdu CN (1)

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01 Rotigotine (4)

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01 China (1)

02 France (1)

03 India (1)

04 Spain (1)

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01 Valid (4)

URL Supplier Web Content
R0-CEP 2022-035 - Rev 00
Valid
Chemical
2023-08-25
3014
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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.

Rotigotine Manufacturers

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

Rotigotine Suppliers

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

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

Rotigotine CEP

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

A Rotigotine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rotigotine 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 Rotigotine suppliers with CEP (COS) on PharmaCompass.

Rotigotine Manufacturers | Traders | Suppliers

Rotigotine Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Rotigotine

Get in contact with the supplier of your choice:

  1. Interquim SA
  2. Seqens
  3. Neuland Laboratories
  4. Sichuan Qingmu Pharmaceutical
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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