Commercial
Manufacturing
Integrated Manufacturing Operations for Commercial Supply
At Aragen, we bring extensive manufacturing expertise in commercial APIs, underpinned by a strong R&D team. This combination allows us to develop commercially viable processes for a wide range of APIs that are supplied to customers globally. We also offer exclusive, long-term commercial manufacturing solutions for APIs and advanced intermediates, designed to support consistent quality and supply requirements.
Our team’s deep experience in process development, validation, and Drug Master File (DMF) preparation enables us to meet the chemistry manufacturing control (CMC) requirements of customer projects with precision.
We provide a smooth transition from laboratory to commercial production. R&D and technology transfer capabilities support scale-up from laboratory through pilot and commercial manufacturing stages where applicable. The strategic co-location of our R&D labs, pilot plants, and commercial manufacturing facilities facilitates a seamless progression from feasibility to commercial supply—ensuring efficient production every step of the way.
Aragen’s multi-accredited manufacturing facilities are designed to handle a diverse array of complex chemistries and operating conditions. This flexibility supports a range of production requirements across development and commercial manufacturing programmes.
Our integrated operations bring together quality control, quality assurance, supply chain management, regulatory expertise, and project management. This holistic approach ensures operational excellence, delivering consistent and timely production of commercial supplies, while maintaining cost-effectiveness and flexibility.
Active Pharmaceutical Ingredients Product Catalogue
| Products | Therapeutic Category | Documents Availability |
|---|---|---|
| Commercially Available | ||
| Betahistine HCl | Anti-Vertigo | DMF |
| Benserazide HCl | Parkinson’s Disease | DMF |
| Dobutamine Hydrochloride | Cardiovascular | CEP/DMF |
| Ezetimibe | Antihyperlipidemic | DMF/KDMF |
| Fingolimod HCl | Multiple Sclerosis | DMF |
| Gatifloxacin Sesquihydrate | Antibiotic | DMF |
| Lamotrigine | Anticonvulsant | CEP/DMF |
| Moxifloxacin Hydrochloride | Antibiotic | CEP/DMF/KDMF |
| Pentosan Polysulfate Sodium | Interstitial Cystitis | USDMF/KDMF/DMF |
| Pralidoxime Chloride | Antidote | DMF |
| Tramadol Hydrochloride | Analgesic | CEP/USDMF/KDMF/JDMF |
| Trimetazidine Dihydrochloride | Cardiovascular | CEP/DMF |
Intermediates Product Catalogue
| Name of the Intermediates | CAS No |
|---|---|
| Aripiprazole 7-(4-Bromobutoxy)-3,4-Dihydroquinoline-2 (BBQ) | 129722-34-5 |
| Benserazide 2,3,4-Trihydroxybenzaldehyde DL-Serinehydrazide monohydrochloride | 2144-08-3 55819-71-1 |
| Carvedilol 4- (2,3 –Epoxypropoxy) carbazole (CVD4) | 51997-51-4 |
| Lamotrigine Hydrazine carboxidazole -2 – [cyano (2,3 – dichlorophenyl)] methane (LA2) 2, 3 Dichloro benzoyl Nitrile(LA1) | 84689-20-3 77668-42-9 |
| Pralidoxime (E)-Picolinaldehdye oxime | 873-69-8 |
Disclaimer: Products covered by valid patents in any country are not offered or supplied to those countries.
The customer should verify the patent position in the concerned country
Leveraging Digital & AI for Optimized Manufacturing Yield
Empowering Smarter, Data-Driven Manufacturing for Consistent & Higher Yields
In today’s fast-paced and data-driven world, Aragen takes a step further to enhance the efficiency and effectiveness of our manufacturing operations by integrating Digital & AI solutions, such as Artificial Intelligence (AI) and Machine Learning (ML) into our commercial manufacturing processes.
Manufacturing yield is often influenced by Critical Process Parameters (CPPs) and the quality of raw materials. Traditionally, analyzing these parameters required time-consuming manual processes, which sometimes led to inefficiencies and missed opportunities for optimization. At Aragen, Golden Batch Analytics is an in-house capability that applies artificial intelligence (AI) and machine learning (ML) technologies to support manufacturing process monitoring and analysis.
Our Digital & AI Solutions for API Manufacturing
Data-Driven Optimization
Aragen uses advanced Machine Learning to analyze past batch data and identify key factors, like temperature and pressure, that affect yield. This automated approach replaces manual analysis and helps optimize your manufacturing process for better efficiency.
Consistent, High-Yield Production
Aragen’s AI-driven models learn from high-yield batches, identifying the best operating conditions for each production cycle. This ongoing learning ensures that your process is always improving, leading to better yields with every batch.
Real-World Results & Tangible Savings
Our Machine Learning models have consistently delivered improvements in yield, leading to higher production efficiency. These yield improvements translate into significant cost savings and better resource utilization, helping to optimize your manufacturing process.
Continuous Optimization
Our AI models continue to learn and refine processes, ensuring ongoing optimization and long-term efficiency gains. This means your operations are always improving, leading to consistent cost reductions.
Custom AI Solutions
At Aragen, we customize our Machine Learning models to fit the unique needs of each product. This ensures that every customer gets a tailored solution aimed at maximizing yield and improving production quality.
Why Aragen?
- Increased Efficiency: Automation of CPP analysis reduces manual effort and leads to faster decision-making.
- Higher Yields: Optimized operating conditions ensure that your production processes consistently achieve higher yields.
- Cost Savings: By improving yield and minimizing waste, we help you lower operational costs, resulting in higher profitability.
- Innovation at Scale: Our AI-powered solutions scale seamlessly from pilot to commercial production, ensuring consistent performance across all stages.
- Continuous Improvement: With machine learning models that learn from each batch, we provide ongoing enhancements to your manufacturing process.
Amplify Your Manufacturing Potential with Aragen
Aragen’s Golden Batch Analytics is an in-house capability that applies artificial intelligence (AI) and machine learning (ML) technologies to support manufacturing process monitoring, data analysis and process evaluation. This capability forms part of our digital and data-driven manufacturing initiatives and supports manufacturing operations through the use of advanced analytics and technology.
Ready to unlock the full potential of your manufacturing process? Discover how our Digital & AI solutions can drive continuous improvements and cost savings for your operations.
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