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Commercial API Manufacturing:
Process Validation, DMF Support and Long-Term Supply

Integrated Manufacturing Operations for Commercial Supply

Aragen Life Sciences manufactures commercial APIs and advanced intermediates for customers worldwide. Our R&D teams develop commercially viable processes. Our manufacturing teams then run them at commercial scale with quality control, quality assurance, supply chain, regulatory and project management working together.

Our teams have experience in process development, validation and Drug Master File (DMF) preparation, which meets the CMC (chemistry, manufacturing and controls) needs of customer projects.

R&D labs, pilot plants and commercial manufacturing facilities are co-located. Scale-up and technology transfer move from laboratory to pilot to commercial scale where applicable.

Active Pharmaceutical Ingredients Product Catalogue

ProductsTherapeutic CategoryDocuments Availability
Commercially Available
Betahistine Di HClAnti-VertigoDMF (CEP in process)
Benserazide HClParkinson’s DiseaseDMF (CEP in process)
Dobutamine HydrochlorideCardiovascularCEP/DMF
EzetimibeAntihyperlipidemicDMF/KDMF
Fingolimod HClMultiple SclerosisDMF
Gatifloxacin SesquihydrateAntibioticDMF
LamotrigineAnticonvulsantCEP/DMF
Moxifloxacin HydrochlorideAntibioticCEP/DMF/KDMF
Pentosan Polysulfate SodiumInterstitial CystitisUSDMF/KDMF/DMF
Pralidoxime ChlorideAntidoteDMF
Tramadol HydrochlorideAnalgesicCEP/USDMF/KDMF/JDMF
Trimetazidine DihydrochlorideCardiovascularCEP/DMF/CADIFA

DMF = Drug Master File. CEP = Certificate of Suitability (Europe). KDMF = Korean DMF. USDMF = US DMF. JDMF = Japanese DMF.
 

Intermediates Product Catalogue

Name of the IntermediatesCAS No
7-(4-Bromobutoxy)-3,4-Dihydroquinoline-2 (BBQ)
129722-34-5
2,3,4-Trihydroxybenzaldehyde
DL-Serinehydrazide monohydrochloride

2144-08-3
55819-71-1
4-(2,3-Epoxypropoxy) carbazole (CVD4)
51997-51-4
Hydrazine carboxidazole-2-[cyano (2,3-dichlorophenyl)] methane (LA2)
2,3 Dichloro benzoyl Nitrile (LA1)

84689-20-3
77668-42-9
2-(3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl) methylthio-1H-benzimidazole (LS)
103577-40-8
(E)-Picolinaldehyde 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.

Frequently Asked Questions (FAQs)

A Drug Master File (DMF) is a confidential submission to a regulator that holds detailed information about an API's manufacture and quality.

See the product catalogues on this page. They list 12 APIs and a set of intermediates.

Yes. R&D labs, pilot plants and commercial facilities are co-located.