Specialty APIs Supplier | cGMP Active Pharmaceutical Ingredients & DMF Support
Commercial and pilot-scale APIs manufactured under cGMP guidelines with complete regulatory documentation for global submission.
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![Nintedanib Esylate]()
Nintedanib EsylateCAS No. 656247-18-6 (Esylate). Molecular Formula: C31H33N5O4 · C2H6O4S. Molecular Weight: 649.76 g/molread more -
![Apixaban]()
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![Olaparib]()
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![Osimertinib Mesylate]()
Osimertinib MesylateCAS No. 1421373-66-1. Molecular Formula: C28H33N7O2 · CH4O3S. Molecular Weight: 599.71 g/molread more -
![Sorafenib Tosylate]()
Sorafenib TosylateCAS No. 284461-73-0 (Tosylate). Molecular Formula: C21H16Cl2N4O3 · C7H8O3S. Molecular Weight: 637.49 g/mol (Tosylate salt)read more -
![Imatinib Mesylate]()
Imatinib MesylateCAS No. 220127-57-1. Molecular Formula: C29H31N7O . CH4O3S. Molecular Weight: 589.71 g/molread more
Category Introduction
Specialty Active Pharmaceutical Ingredients require tight solid-state controls, validated purification steps, and explicit organic/inorganic impurity profiles. This product group includes small-molecule APIs applied in cardiovascular, antiviral, and diagnostic imaging formulations.
Production takes place in dedicated reactor lines complying with cGMP standards. Process control includes particle size reduction, polymorphism monitoring via XRD, and residual solvent removal to limits below ICH Q3C threshold levels.
Product Portfolio
|
Product Name |
CAS Number |
Main Therapeutic Class |
Purity (HPLC) |
Key Specification Controls |
Regulatory Status |
|
Rosuvastatin Calcium |
147098-20-2 |
Cardiovascular |
≥ 99.0% |
Enantiomeric impurity ≤ 0.10%, $D_{90} < 20\,\mu\text{m}$ |
USDMF / CEP / EU-GMP |
|
Ranolazine |
95635-55-5 |
Anti-anginal |
≥ 99.5% |
Total impurities ≤ 0.50%, Individual unknown ≤ 0.05% |
USDMF / EU-GMP |
|
Tenofovir Disoproxil Fumarate |
202138-50-9 |
Antiviral |
≥ 98.5% |
Form I crystalline purity, Genotoxic impurity screen |
USDMF / CEP |
|
Atazanavir Sulfate |
229975-97-7 |
Antiretroviral |
≥ 99.0% |
Diastereomer balance, Residual solvents (Ethanol/Acetone) |
USDMF |
|
Etoricoxib |
202409-33-4 |
Selective COX-2 Inhibitor |
≥ 99.5% |
Single specified impurity ≤ 0.10%, Heavy metals ≤ 10 ppm |
USDMF / EU-GMP |
|
Iopamidol |
60166-93-0 |
X-ray Contrast Agent |
≥ 98.5% |
Free iodine ≤ 10 ppm, Bacterial endotoxins < 0.5 EU/mg |
USDMF / CEP / cGMP |
Batch release testing follows USP, EP, and ChP monograph requirements. Specifications cover key chemical, physical, and analytical attributes required for solid oral and parenteral dosage formulations:
Assay & Impurity Profile: HPLC assay limits set at 98.5%–100.5% (dried basis). Impurity profiling tracks synthesis-related substances and degradation products according to ICH Q3A/B guidelines, with single unknown impurities capped at ≤ 0.05%.
Particle Size Distribution (PSD): Controlled via air-jet micronization or mechanical milling. Customized targets available down to D90 < 10 μm or defined ranges (D10, D50, D90) verified by laser diffraction particle size analysis.
Polymorph Verification: X-ray Powder Diffraction (XRPD) and Differential Scanning Calorimetry (DSC) confirm crystal structure stability and phase identity across production lots.
Solvents & Elemental Impurities: Headspace Gas Chromatography (GC-HS) quantifies Class 1, Class 2, and Class 3 residual solvents. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) tests for heavy metal limits aligned with ICH Q3D options 1 or 2.
Product & Supply Status
Production Scale
Multi-ton commercial production lines operating alongside kilogram-scale equipment for clinical and pilot-batch orders.
Packaging Solutions
Primary packaging consists of double food/pharma-grade polyethylene bags inside heat-sealed aluminum foil bags, enclosed in outer HDPE drums. Nitrogen flushing and light-protective options available based on stability profile requirements.
Evaluation Samples
10g to 100g verification samples supplied with full lot-specific Certificate of Analysis (COA) for incoming inspection and laboratory testing.
Manufacturing & Technical Capabilities
Reaction Vessels
Glass-lined and stainless steel reactors ranging from 500 L to 5,000 L operating at temperature ranges from -78 °C to 200 °C.
Core Reactions
Asymmetric synthesis, catalytic hydrogenation, optical resolution, halogenation, and controlled crystallization.
Cleanroom Operations
Class 100,000 (ISO 8) cleanrooms dedicated to drying, milling, sieving, and packaging operations. Equipment includes agitated nutsche filter-dryers, fluid bed dryers, and micronizers.
Analytical Instrument Control
In-house testing laboratory equipped with HPLC-UV/CAD, GC-FID/HS, ICP-MS, FTIR, Karl Fischer titrators, and laser particle size analyzers.
GMP Compliance: Quality system configured in accordance with ICH Q7 guidelines for active pharmaceutical ingredients.
Regulatory Submissions: Drug Master Files (USDMF, CEP/EDMF) maintained in eCTD format. Letters of Access (LOA) generated upon customer registration and commercial verification.
Stability Testing: Real-time stability testing (25 °C ± 2 °C / 60% ± 5% RH) and accelerated stability testing (40 °C ± 2 °C / 75% ± 5% RH) conducted according to ICH Q1A(R2) protocols.
Audits: Customer quality audits and regulatory inspections accommodated with full access to batch production records, analytical raw data, and cleaning validation protocols.
Documentation Support: Every batch shipment includes COA, SDS, Method of Analysis (MOA), Process Flow Diagram, and TSE/BSE Non-Use Statements. Nitrosamine and Elemental Impurity Risk Assessment reports available upon request.
Minimum Order Quantity (MOQ): Pilot orders starting at 1 kg–5 kg; standard commercial order MOQ is 25 kg.
Lead Time: 2–3 weeks for stock items; 4–6 weeks for custom micronization or scheduled batch production.
Shipping Conditions: Ambient, chilled (2 °C–8 °C), or frozen storage/transit packaging matching specific product stability profiles.
FAQ
Request Technical Documentation & Pricing
Submit your specification requirements, target volume, and required regulatory filings. Our technical and regulatory support team responds within 24 business hours.
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