Available EU DMF/CEP
API Status
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Chlorpromazine hydrochloride



Reference product


Polymorphic form

Crystalline anhydrous form II

Therapeutic Area

Nervous system



EU DMF readiness

US DMF readiness


Available also in injectable form

Drug description:

Chlorpromazine hydrochloride is an anti-emetic and antipsychotic agent.
It is indicated for the treatment of schizophrenia, to control nausea and vomiting, for relief of restlessness and apprehension before surgery, acute intermittent porphyria, as an adjunct in the treatment of tetanus, to control the manifestations of the manic type of manic-depressive illness and for relief of intractable hiccups.
It is formulated as sugar coated tablets for oral route of administration.

Mechanism of action:

Chlorpromazine has depressant actions on the Central Nervous System, with alpha-adrenergic blocking and anticholinergic activities. It inhibits Dopamine and Prolactin release-inhibitory factor, thus stimulating the release of Prolactin. It increases the turnover of Dopamine in the brain. It has anti-emetic, anti-puritic, serotonin-blocking and weak anti-histamine properties and slight ganglion blocking activity. It inhibits the heat regulating center in the brain, and is analgesic and can relax skeletal muscle. Due to its action on the autonomic system it produces vasodilatation, hypotension and tachycardia. Salivary and gastric secretions are reduced.

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).