Rotigotine API
| CAS No. | 99755-59-6 |
| Therapeutic Category | Neurology & Psychiatry |
| Technology | Synthetic |
| Dosage Form | Transdermal patches |
| Innovator Brand | Neupro, Leganto(USA) |
| Registration Status | China: Under preparing US: DMF 038363 EU: CEP 2022-035 Others: DMF |
| Polymorph | Form II |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: 1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-, (6S)-
- Molecular Formula: C19H25NOS
- Molecular Weight: 315.473
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade or milling/sieving according to customer’s requirement.
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Rotigotine API
- 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. Rotigotine has been authorized as a treatment for RLS since August 2008.
Why Choose Us as Your Rotigotine Factory?
- As a Rotigotine factory, Qingmu’s Rotigotine API has been approved in China(DMF filed and listed on CDE’s website), USDMF and CEP certificates have also been granted, and DMF in CTD format is available and can be supported for registration worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to removing the factory. A new API factory is under design and is predicted to be put into use in 2025.
- Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) as well as customer audits from Europe, USA, Japan, etc.
- Qingmu, as one of the leading Rotigotine manufacturers, successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. We are always ready to provide all customers with the best quality products and services
