Amisulpride- Amitriptyline HCL
- Aripiprazole
- Baclofen
- Escitalopram Oxalate
- Fluoxetine HCL
- Levocetirizine Di HCL
- Lorazepam
- Mirtazapine HCL
- Olanzapine
- Quetiapine Fumarate
- Risperidone
- Tizanidine HCL
Frequently Asked Questions
SSRIs such as Escitalopram and Fluoxetine work by selectively inhibiting the reuptake of serotonin in the synaptic cleft, increasing serotonin availability to postsynaptic receptors. They are first-line treatment for depression and anxiety disorders. Mirtazapine, as a NaSSA (Noradrenergic and Specific Serotonergic Antidepressant), has a dual mechanism: it blocks alpha-2 adrenergic autoreceptors to increase norepinephrine and serotonin release, while antagonizing 5-HT2 and 5-HT3 receptors to reduce serotonergic side effects. Mirtazapine is particularly useful when sleep disturbance and appetite loss are prominent symptoms, as it promotes sleep and appetite.
Aripiprazole is unique among atypical antipsychotics as it functions as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, rather than as a full antagonist. This means it stabilizes dopamine activity — reducing overactivity in mesolimbic pathways (improving positive symptoms) while increasing underactivity in mesocortical pathways (improving negative symptoms and cognitive function). This mechanism results in a lower risk of extrapyramidal symptoms, hyperprolactinemia, and metabolic side effects compared to full antagonist antipsychotics like Olanzapine and Risperidone.
Our CNS-active APIs undergo rigorous impurity profiling beyond standard pharmacopeial requirements. We perform genotoxic impurity assessment per ICH M7 guidelines, with particular attention to alkyl chloride and hydrazine derivatives that may form during synthesis of these APIs. Ames testing and computational toxicology (QSAR) assessments are conducted for impurities at or above the ICH M7 threshold of toxicological concern. We also monitor for residual genotoxic solvents and potential nitrosamine impurities in compliance with recent regulatory requirements for sartan-type and other CNS medications.
Yes, we can supply neurological and psychiatric APIs in specific polymorphic forms as required. Polymorphism is critical for CNS APIs because different crystal forms can exhibit significantly different solubility, dissolution rate, and bioavailability. We can characterize and control polymorphic form using X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and Raman spectroscopy. For each API, we ensure consistent polymorphic form across batches and provide comprehensive solid-state characterization data to support regulatory filings.
We provide comprehensive drug master file (DMF) support for psychiatric medication registrations in regulated markets including the US FDA, EMA, Health Canada, TGA, and PMDA. Our DMF packages include detailed synthesis descriptions with critical process parameters, specifications with justified acceptance criteria, batch analysis data from three validation batches, impurity qualification data including genotoxic impurity assessments, stability data under ICH conditions, container closure system information, and environmental risk assessments. We also provide right of reference letters and respond to regulatory authority queries throughout the review process.