EU DMF readiness
US DMF readiness
Supporting your FDF launch:
- R-baclofen hydrochloride salt – straightened chemical stability
- R-baclofen co-crystals (labolatory stage) – straightened chemical stability; applied patent application – can be considered upon request
- Technical support available on request
Baclofen is a muscle relaxer and an antispastic agent.
Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumours of the spinal cord, motor neurone disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord. Baclofen is indicated for adults and children in the relief of spasticity of voluntary muscle arising from conditions such as cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis.
Mechanism of action:
Arbaclofen acts as selective GABAB receptors agonist. GABA (gamma-aminobutyric acid) is the major inhibitory neurotransmitter in the brain. Its production, release, re-uptake and metabolism occur in the nervous system.
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).
The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.