Active Pharmaceutical Ingredients
High-purity APIs synthesized in GMP-certified facilities with complete regulatory documentation — from cardiovascular agents to CNS compounds.
API Portfolio
Pharmaceutical Ingredient Range
GMP-certified APIs with full documentation packages — serving manufacturers and formulators globally.
Cardiovascular Agents
A comprehensive range of high-purity cardiovascular APIs for hypertension management, dyslipidemia treatment, and cardiac rhythm control. Available in multiple particle sizes and polymorphic forms.
- ACE inhibitors and ARBs (antihypertensives)
- Statins and fibrates for cholesterol and lipid management
- Beta-blockers and calcium channel blockers
- Anticoagulants and antiplatelet agents
- Available in standard and micronized particle grades
- Polymorphic form specifications provided on request
Anti-Infectives & Antibiotics
Broad and narrow-spectrum antimicrobial APIs covering bacterial, fungal, and viral targets. All compounds synthesized under GMP conditions with full impurity profiling.
- Broad-spectrum beta-lactam antibiotics (penicillins, cephalosporins)
- Fluoroquinolones for respiratory and urinary tract infections
- Macrolides and aminoglycosides
- Antifungals: azoles and polyenes
- Antiviral compounds for HIV, hepatitis, and influenza
- Impurity profiling and residual solvent testing included
Analgesics & Anti-Inflammatories
NSAIDs, opioid analgesics, and selective COX-2 inhibitors in standard and micronized grades. Supplied with complete stability data and ICH-compliant documentation.
- NSAIDs: ibuprofen, naproxen, diclofenac — standard and micronized
- Selective COX-2 inhibitors for GI-sparing pain management
- Opioid analgesics under controlled synthesis (license required)
- Paracetamol / acetaminophen — pharmaceutical and compounding grades
- Corticosteroids for systemic and topical anti-inflammatory use
- Full ICH Q1A stability data available on request
CNS Agents
Neurological and psychiatric APIs synthesized under strict controlled conditions. All CNS compounds are subject to enhanced quality controls, with dedicated regulatory support for controlled substance dossiers.
- Antidepressants: SSRIs, SNRIs, and TCAs
- Antipsychotics: typical and atypical classes
- Anti-epileptics and mood stabilizers
- Anxiolytics and hypnotics
- Parkinson's disease compounds (dopaminergic agents)
- Controlled substance licensing assistance included
Complete Documentation Package
Every API comes with a comprehensive regulatory dossier package — ensuring frictionless submissions in any ICH jurisdiction.
Drug Master File (DMF)
Type II DMFs filed with FDA, EMA, or local regulatory authorities covering manufacturing process, specifications, and impurity profiles.
Certificate of Eligibility (CEP)
European Pharmacopoeia CEPs confirming compliance with Ph. Eur. monographs for API quality and purity.
CTD Dossier (Module 3)
Complete Common Technical Document (CTD) Module 3 quality dossiers for regulatory submissions in any ICH jurisdiction.
CoA & Stability Data
Batch-specific Certificates of Analysis, ICH Q1A stability studies, and shelf-life data for every API batch.
GMP Certified Synthesis
All APIs manufactured in GMP-certified facilities audited to ICH Q7 standards for active pharmaceutical ingredients.
Impurity Profiling
Full impurity profiling per ICH Q3A guidelines, with residual solvent testing per ICH Q3C for every batch.
Pharmacopoeia Compliance
APIs tested against USP, Ph. Eur., IP, and BP monographs — Certificates of Analysis provided with every shipment.
Source GMP-Certified APIs
Submit an inquiry with your required compound, grade, and volume. Our regulatory team will respond with full documentation details within 24 business hours.