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Generic APIs Manufacturer & Regulatory Support

cGMP-compliant active pharmaceutical ingredients produced for global commercial formulation and regulatory submissions.

Omeprazole
CAS No. 73590-58-6. Molecular Formula: C17H19N3O3S. Molecular Weight: 345.42 g/mol
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Celecoxib
CAS No. 169590-42-5. Molecular Formula: C17H14F3N3O2S. Molecular Weight: 381.37 g/mol
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Meloxicam
CAS Registry Number: 71125-38-7. Molecular Formula: C14H13N3O4S2. Molecular Weight: 351.40 g/mol
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Carvedilol
CAS No. 72956-09-3. Molecular Formula: C24H26N2O4. Molecular Weight: 406.48 g/mol
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Enalapril Maleate
CAS No. 76095-16-4. Molecular Formula: C24H28N2O9. Molecular Weight: 492.49 g/mol
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Lisinopril
CAS No. 83915-83-9. Molecular Formula: C21H31N3O5. Molecular Weight: 405.49 g/mol
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Category Introduction

This category covers commercial-scale Generic APIs synthesized in cGMP-compliant facilities operating under ICH Q7 guidelines. The portfolio provides active substances for cardiovascular, antiviral, oncology, and central nervous system therapeutics.

Synthetic operations utilize automated reactor systems with multi-step chemical processing capabilities. Each active substance is supported by complete technical packages, impurity profiling, nitrosamine risk assessments, and regulatory documentation for global dossier filings.

Product Portfolio

Generic API Name	CAS Number	Empirical Formula	Therapeutic Category	Key Control Parameters	Regulatory Support
Rosuvastatin Calcium	147098-20-2	C₄₄H₅₄CaF₂N₈O₁₂S₂	Antihyperlipidemic	Diastereomer ≤ 0.10%; Micronized grade d90 < 10 μm	US DMF, CEP, EU-GMP
Tenofovir Disoproxil Fumarate	202138-50-9	C₁₉H₃₀N₅O₁₀P · C₄H₄O₄	Antiviral (HIV / HBV)	Mono-ester impurity < 0.15%; Isopropanol control strictly within limits	US DMF, CEP
Ranolazine	95635-55-5	C₂₄H₃₃N₃O₄	Antianginal	Polymorphic Form I verified by XRPD; Single unknown impurity < 0.05%	US DMF, Tech Package
Pazopanib Hydrochloride	635702-64-6	C₂₁H₂₃N₇O₂S · HCl	Oncology	Genotoxic impurities evaluated per ICH M7; Controlled particle habit	US DMF, Tech Package
Etoricoxib	202409-33-4	C₁₈H₁₅ClN₂O₂S	NSAID (COX-2 Inhibitor)	Related substances A/B < 0.10%; Heavy metals compliant with ICH Q3D	US DMF, Tech Package

Product Information

Specifications are defined to meet or exceed current USP, EP, and JP pharmacopeial monographs.

Purity & Impurity Profiling: HPLC assay purity routinely exceeds 99.5%. Synthesis pathways limit single unspecified impurities below 0.05%. Analytical methods include ICH M7 genotoxic evaluations and LC-MS/MS nitrosamine screening.

Particle Engineering: Micronization achieved via fluid-energy jet milling. Custom particle size distributions (PSD) are adjusted to match target dissolution and bioavailability parameters in solid oral dosage forms.

Polymorphic Control: Differential Scanning Calorimetry (DSC) and X-ray Powder Diffraction (XRPD) verify crystal form stability across commercial lots.

Solvent Control: Headspace Gas Chromatography (GC-FID) quantifies residual Class 1, 2, and 3 solvents strictly within ICH Q3C limits.

Product & Supply Status

Production Capacity: Metric-ton annual scale with commercial batch output ranging from 50 kg to 500 kg per reaction cycle.

Commercial Availability: Validated campaign production active. Commercial lots in stock for immediate dispatch.

Packaging: Outer fiber drums lined with double food/pharma-grade polyethylene bags and aluminum foil light-barrier protection. Standard sizes: 10 kg, 25 kg, and 50 kg.

Sample Logistics: Evaluation samples (10g–100g) shipped with full Certificate of Analysis (CoA), spectral data, and analytical methods.

Manufacturing & Technical Capabilities

Synthesis reactions are carried out in dedicated bays equipped with glass-lined, stainless steel, and Hastelloy reactors ranging from 500L to 10,000L.

Reaction Unit Operations

Cryogenic synthesis (-78 °C), catalytic pressure hydrogenation (up to 5 MPa), fractional crystallization, and halogenation.

Isolation & Cleanrooms

Enclosed filtration using Agitated Nutsche Filter Dryers (ANFD). Final milling, sieving, and drum filling are conducted in ISO Class 7 (Class 10,000) cleanroom environments.

Process Automation

Distributed Control Systems (DCS) record critical process parameters (temperature, pressure, agitation, pH) in real time to ensure batch reproducibility.

Quality & Regulatory Information

Quality systems conform to cGMP standards with continuous oversight across all production operations.

Regulatory Status: Inspected and aligned with US FDA, EMA, and NMPA cGMP requirements.

Quality Management: Automated change control, deviation tracking, and Out-of-Specification (OOS) investigations based on root-cause analysis.

Dossier Support: Drug Master Files (DMF) compiled in eCTD structure for direct integration into ANDA or MAA filings.

Analytical Testing: In-house laboratory equipped with HPLC, UPLC, GC-Headspace, LC-MS/MS, ICP-MS (elemental impurities), XRPD, Malvern Mastersizer, and stability chambers operating under ICH Q1A–Q1E conditions.

Procurement Information

Minimum Order Quantity (MOQ): 1 kg for trial/R&D batches; 25 kg for commercial supply.

Lead Times: 2–3 weeks for stocked inventory; 6–8 weeks for campaign manufacturing runs.

Cold-Chain Delivery: Temperature-controlled shipping options (2 °C - 8 °C or -20 °C) accompanied by calibrated temperature data loggers.

Documentation Included:

Batch Certificate of Analysis (CoA)
GHS-compliant Safety Data Sheet (SDS)
Method of Analysis (MoA) & Method Validation Summary
BSE/TSE Risk Statement
Elemental Impurities Statement (ICH Q3D)
Residual Solvents Statement (ICH Q3C)

FAQ

Q: How are nitrosamine impurity risks evaluated for these Generic APIs?

A: Each synthesis route undergoes a nitrosamine risk assessment covering starting materials, water loops, recovered solvents, and side reactions. Testing is validated using LC-MS/MS to ensure levels stay below acceptable intake (AI) limits specified by FDA and EMA guidance.

Q: Can particle size specifications be customized for low-solubility active substances?

A: Yes. Dedicated air-jet milling equipment allows precise control over particle size parameters (such as d10, d50, d90) to align with formulation dissolution profiles.

Q: What regulatory support is provided when referencing a DMF for market authorization?

A: A Letter of Authorization (LoA) is provided upon quality agreement execution. Technical regulatory teams assist directly with deficiency letters and information requests during dossier review cycles.

Q: How is crystal form consistency verified across commercial batches?

A: Batch process consistency is controlled via automated DCS systems. Finished lots undergo XRPD and DSC analysis to confirm crystal form identity and thermal properties before final quality release.

Q: What is the procedure for scheduling an audit of the manufacturing site?

A: Facility audits are accommodated upon request. Quality Assurance provides the Site Master File (SMF) and audit questionnaires prior to scheduling on-site or virtual inspections.

Request Technical Documentation & Commercial Quotes

Submit target API specifications, required regulatory documentation, and estimated annual quantities. Technical sales specialists and regulatory managers respond within 24 hours.

[ Request DMF Open Part & LoA ] [ Submit Commercial Quote Request ]

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