Our products

Baclofen

CAS No.

1134-47-0

Reference product

Lioresal, Liofen, Gablofen/NOVARTIS

Polymorphic form

Form B

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

US DMF readiness

018014

CEP

Other documentation

Japanese DMF
Korean DMF
Canadian DMF
Brazilian DMF

💉 Available also
in injectable form

Drug description:

Baclofen is a muscle relaxer and an antispastic agent.
It is indicated for the relief of spasticity of voluntary muscle resulting from disorders such as multiple sclerosis and other spinal lesions, including tumors of the spinal cord, motor neuron disease, syringomyelia, transverse myelitis and traumatic partial section of the spinal cord. Baclofen is dedicated 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:

Baclofen, a GABA (gamma-aminobutyric acid) derivative, is chemically unrelated to other antispastic agents and acts at spinal level, reducing spasticity and spasm. Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably by simulating the GABAB-receptors, this simulation in turn inhibiting the release of the excitatory amino acids glutamate and aspartate.

Disclaimer
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).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
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.

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