Global Calcium is one of the leading manufacturers and exporters of Clobazam CAS no. C16H13ClN2O2, API, (Active Pharmaceutical Ingredient). We support the customers with exhaustive documentation. As a USDMF & EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979.

As manufacturer of Clobazam we hereby state the following facts about the drug:

Clobazam is a 1,5-benzodiazepine and partial gamma-aminobutyric acid (GABA) receptor agonist, with anxiolytic, sedative, and anticonvulsant activities. Clobazam binds to a specific site, distinct from the inhibitory neurotransmitter GABA binding site, on the benzodiazepine-GABA-A-chloride ionophore receptor complex located in the central nervous system. This binding causes an allosteric modification of the receptor and enhances the affinity of GABA to the receptor leading to an increase in the opening of chloride-channels. This leads to an increase in chloride ion conductance, neuronal hyperpolarization, inhibition of the action potential and a decrease in neuronal excitability.

Therapeutic uses and effectiveness:

• For treatment and management of epilepsy and seizures associated with Lennox-Gastaut syndrome, a difficult-to-treat form of childhood epilepsy (patients 2 years of age or older)
• Clobazam currently is FDA-labeled only for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. However, the drug has demonstrated broad anticonvulsant activity and has been used extensively in adults and pediatric patients with a wide range of other seizure disorders, which have sometimes been refractory, including partial, generalized, and myoclonic seizures.
• Clobazam has been used in the treatment of anxiety disorders and has been labeled for the short-term (2-4 weeks) treatment of anxiety in some countries outside the US. However, the drug currently is not FDA-labeled for the treatment of anxiety disorders in the US.
• It is a GABA-A Receptor Agonists: Endogenous compounds and drugs that bind to and activate GABA-A receptors

Other related information:

• Clobazam is a DEA Schedule IV controlled substance:  The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III
• Clobazam is a benzodiazepine that is used as an anticonvulsant in the therapy of severe childhood epilepsy. Therapy with clobazam has not been associated with serum aminotransferase elevations, and clinically apparent liver injury from clobazam has yet to be reported and must be rare, if it occurs at all.
• Since clobazam has a CNS depressant effect, patients or their caregivers should be cautioned against concomitant use of other CNS depressant drugs or alcohol, and cautioned that the effects of other CNS depressants or alcohol may be potentiated.
• Somnolence and sedation are among the most common adverse effects associated with clobazam therapy. In a placebo-controlled study of patients with Lennox-Gastaut syndrome, somnolence or sedation was reported in 26% of patients who received clobazam compared with 15% of those who received placebo. Somnolence and sedation were observed at all effective dosages in clinical trials and were dose related. The sedative effect of clobazam is reportedly less pronounced than that of other commercially available benzodiazepines
• Withdrawal symptoms (e.g., convulsions, psychosis, hallucinations, behavioral disorders, tremor, anxiety, irritability, dysphoria, insomnia, headache, palpitations, diarrhea) have been reported following abrupt discontinuance of benzodiazepines, including clobazam. Milder withdrawal symptoms (e.g., dysphoria, anxiety, insomnia) generally have been reported following abrupt discontinuance of benzodiazepines in patients continuously receiving therapeutic dosages for several months

Global Calcium is a leading manufacturer of this drug. We manufacture this pharmaceutical drug and make it available to domestic and overseas market