API Development Pipeline | Active Ingredients in R&D and Scale-Up
Access technical data packages, impurity profiles, and validation samples for early-stage and scale-up API development.
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![Ensitrelvir Fumaric Acid]()
Ensitrelvir Fumaric AcidCAS No. 2757470-18-9. Molecular Formula: C26H21ClF3N9O6. Molecular Weight: 647.95 g/molread more -
![Fezolinetant]()
FezolinetantCAS Number: 1629229-37-3. Molecular Formula: C16H15FN6OS. Molecular Weight: 358.39 g/molread more -
![Ubrogepant]()
UbrogepantCAS Registry Number: 953762-84-8. Molecular Formula: C29H26F6N6O3. Molecular Weight: 624.55 g/molread more -
![Abrocitinib]()
AbrocitinibCAS Registry Number: 1622908-18-2. Molecular Formula: C14H21N5O. Molecular Weight: 275.35 g/molread more -
![Baricitinib]()
BaricitinibCAS No. 1187594-09-7. Molecular Formula: C16H17N7O2S. Molecular Weight: 371.42 g/molread more -
![Linagliptin]()
LinagliptinCAS No. 668270-12-0. Molecular Formula: C25H28N8O2. Molecular Weight: 472.54 g/molread more
Category Introduction
Managing regulatory risks and raw material specs early in formulation reduces downstream tech-transfer delays. The API Development Pipeline covers active pharmaceutical ingredients currently undergoing synthetic route optimization, process validation, or scale-up manufacturing. Each compound includes full analytical characterization, impurity profiling, and stability data aligned with ICH guidelines to support global regulatory filings.
Product Portfolio
Data packages, crystalline form reports, and analytical reference standards are accessible under a Non-Disclosure Agreement (NDA).
Cardiovascular & Metabolic Pipeline
Focus on tight polymorph control, residual solvent limits, and low impurity thresholds for oral solid dose development.
Central Nervous System (CNS) Pipeline
Engineered crystallization processes to ensure controlled particle size distribution (PSD) for uniform dissolution rates.
Antiviral & Anti-Infective Pipeline
Multi-step catalytic synthesis managed in high-containment processing units.
Oncology & High-Potency Pipeline
Process engineering supported by isolation systems tailored for active substances with tight occupational exposure limits (OEL).
Product Information
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Active Ingredient / Code |
CAS Number |
Indication / Application |
Dosage Form |
Available Documentation Package |
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Rosuvastatin Intermediate Derivative |
Under NDA |
Cardiovascular / Dyslipidemia |
Tablet / Capsule |
Synthetic Route, Mass Spec, Impurity Profile |
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Ranolazine Advanced Pipeline |
Under NDA |
Anti-anginal |
Extended Release |
COA, Lab-Scale Stability Summary, PSD Report |
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Tenofovir Derivative |
Under NDA |
Antiviral |
Film-Coated Tablet |
Tech Transfer File, Method Validation Protocol |
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Pazopanib Related Pipeline |
Under NDA |
Oncology |
Oral Suspension |
Polymorph Screening, Structural Elucidation |
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Contrast Media Pipeline |
Under NDA |
Diagnostic Imaging |
Injectable Solution |
Genotoxic Impurity Risk Assessment, Tech Pack |
Route Selection & Lab Scale (100g – 1kg)
- Execution: Synthetic route defined; analytical method development underway.
- Deliverables: Analytical samples for early formulation screening, initial impurity identification, draft specifications.
Pilot Scale & Process Optimization (10kg – 100kg)
- Execution: Critical Process Parameters (CPP) established; method validation active; ICH stability testing ongoing.
- Deliverables: Pilot batches, 3-month and 6-month stability summaries, preliminary Open Part DMF / Tech Pack.
Commercial Scale-Up & Regulatory Filing (100kg+)
- Execution: Process validation completed in GMP-compliant reactors; regulatory dossier compilation active.
- Deliverables: Commercial evaluation samples, full USDMF / CEP data packages, validation batch COAs.
Reactor Capacity & Conditions: Glass-lined and stainless-steel vessels from 50L to 5,000L. Reaction parameters operating from -78°C to +200°C; pressure equipment rated to 5 MPa.
Physical & Particle Control: Air-jet milling, mechanical micronization, and controlled crystallization to yield specific d90, d50, d10 particle profiles.
Analytical Testing Instrumentation:
- HPLC (UV, CAD, MS detection) for purity and related substance monitoring.
- GC for residual solvent profiling.
- PXRD and DSC for crystalline form verification.
- Laser diffraction particle size analyzers.
Quality & Regulatory Information
Quality Framework
Manufacturing and quality control follow ICH Q7 guidelines for active pharmaceutical ingredients.
Impurity Management
Routine risk evaluation for elemental impurities (ICH Q3D), residual solvents (ICH Q3C), and mutagenic impurities (ICH M7).
Regulatory Submissions
Technical dossiers structured in eCTD format to facilitate seamless Drug Master File (DMF) referencing.
Sample & Technical Package Request Pathway:
1. Submit technical inquiry detailing required specs and target volume.
2. Execute NDA to exchange complete Technical Data Packages (Tech Packs).
3. Receive evaluation samples along with batch COA and MSDS.
Order Volumes: Flexible scale options matched to project stage (Lab evaluation: 10g – 500g; Pilot verification: 1kg – 25kg; Scale-up: Commercial drum sizes).
Packaging Standards: Double PE bags placed in anti-static aluminum foil bags, packed in UN-certified fiber drums. Light-resistant or cold-chain packaging supplied when specified.
Sample Delivery: Dispatched within 5 to 10 business days upon request confirmation.
FAQ
Request Technical Data Package & Evaluation Samples
Submit your required parameters to receive technical dossiers, impurity data, or validation samples for API development projects.
[ Request Tech Pack & NDA ] [ Request API Sample ]
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