Generic APIs and process development. Ankleshwar, Gujarat, since 1993.
Difficult chemistry, made at scale.
One company, from the first milligram on the bench to tonnes a month in the plant.
Stylised particle model. Move your cursor through it.
Illustrative trace, not analytical data.
Two ways in
Buyers and formulators usually arrive with one of two questions. Pick yours.
Source an API
You need a qualified supply of a molecule we already make.
- Commercial APIs7
- Regulatory fileDMF or technical package
- US referenceUSDMF 26343, Nebivolol
- Letter of AccessOn request
Develop a process
You have a molecule and need a route that holds up in a plant. We take it through four stages, and ten more APIs are moving through them now.
- 1Development
- 2Lab validation
- 3Scale-up
- 4Commercial
- FocusRoute development, polymorphs, impurity profiling
- ExpertiseChiral separation, stereoselective synthesis, hydrogenation
Pipeline
17 APIs across four stages. Filter by therapeutic area to see what is on the shelf and what is on its way.
Filing dates shown as to confirm were targets published around 2012 and have not been verified. Products protected by valid patents are not offered for sale in countries where the sale would constitute patent infringement.
Chemistry
25 reaction types in routine use, grouped by family, and the window of temperature and batch size we run them in.
Scale ladder
Five rungs from bench to bulk. A process moves up only when it is ready for the next one. Select a rung and watch the vessel light up.
Quality
Release decisions sit with people who do not run the plant, and most of the testing happens under our own roof.
Quality assurance is independent of production and of quality control.
- In-process checks during manufacturing
- Validation of facilities, equipment, processes and cleaning
- Batch release
- Customer and regulatory audits
- Supplier and internal audits
- Document control, record and sample retention
- cGMP training
Manufacturing follows current GMP guidelines. Certifications (WHO-GMP, EU-GMP) to confirm
| Instrument or facility | Used for | Where |
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Export markets
Eight markets, with regulatory affairs built around the European Union, the United States and Japan. Point at a market to trace its route from Ankleshwar.
Supplied from Ankleshwar, Gujarat. Number of manufacturing sites to confirm. The globe shows routes only and is not a map.
Start the conversation
Tell us which of three things you need and we will ask only for what that request takes.
A quote needs a product, a quantity and a destination. A Letter of Access needs the DMF and the applicant. A development brief needs the molecule and the scale you are aiming for.
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