R-Baclofen hydrochloride *

About us Polpharma Group Polpharma API API Manufacturing sites

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from mid-2023 with full completion scheduled for Q1 2024.

CDMO Competencies & Services Quality Environmental protection Customer experience

Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

Generics Core competencies Products

Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias. Our products can be additionally tested in compliance with the customer’s specifications.

Technologies Cryogenic High Potent Capabilities

Our products

R-Baclofen hydrochloride *

CAS No.

63701-55-3

Reference product

N/A

Polymorphic form

Crystalline HCl form

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

✓

US DMF readiness

033383

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).

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

Drug description:

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.