Commercial API Manufacture and Supply
Here at Aptuit we have developed the capacity to provide commercial and post-commercial production for niche products (up to low, single-digit tons) at our US and UK facilities. We also have full commercial manufacturing capabilities at Laurus Labs, our strategic partners’ facilities in Vishakhapatnam, India, providing unique flexibility in our capacity to respond to your specific supply demands, including dual site options, which provides a second-sourced, minimized risk. We also supply a single solution to API development and manufacture throughout your drug development program. This could involve API development in the US, Italy or the UK transferred to large scale manufacturing in India, or, conversely, bulk supply of early stage intermediates from our partners in India can be transferred for final stage cGMP production at either US or UK API sites.
Commercial
Aptuit will provide consistent supplies of bulk actives, generics, or pharmaceutical intermediates in commercial quantities. Our production team will develop the appropriate protocols and process understanding to validate the process, and, thus, guarantee product consistency and purity from batch to batch, all under the careful guidance of Quality Assurance. We are committed to maintaining the highest standards of regulatory and environmental compliance as regulatory demands increase. Our production facilities are FDA inspected and, in the case of our Oxford, UK, facility, MHRA approved.
Our partners', Laurus Labs, site in India also has TGA approval. These facilities are designed to safely handle complex, multi-step organic synthesis in kilogram to multiple metric ton quantities.
We can fine tune supply generation to stay in line with your changing needs.
- We can gear up quickly, cutting down time before your launch.
- We have the versatility to switch from product to product, allowing fast attention to your specific needs.
- We can help you in your launch, qualifying raw materials suppliers and consulting with our wide range of expertise.
Harrisonville, KS - Facility EquipmentSuite A - (2) 1200L glass-lined reactors
- 800L Hastelloy reactor
- 400L glass-lined reactor
- Tray Dryer
- Rotary Cone Dryer
Suite B - (2) 1200L glass-lined reactors
- 400L glass-lined reactor
- Tray Dryer
Suite C - 400L glass-lined reactor
- 120L glass-lined reactor
- Isolator
Suite D - 1000L glass-lined reactor
- 400L glass-lined reactor
- Isolator
Suite E - 100L glass-lined reactor
- 20L Hastelloy hydrogenator and a multi-kilo Biotage 400L Chromatography System
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Oxford, UK - Facility EquipmentBuilding 150
- 100L glass-lined reactor
- 250L glass-lined reactor
- 400L Hastelloy reactor
- 400L Hastelloy reactor (cryogenic)
- 4 Nutsche Filters
- 2 Hastelloy Filter-Dryers
- 1 Stainless Steel Tray Dryer
- 20L Hastelloy hydrogenator and a multi-kilo Biotage 150L Chromatography System
Building 117 - 1600L Hastelloy reactor (cryogenic, pressure hydrogenation)
- 1200L Hastelloy reactor
- (2) 1200L glass-lined reactor
- 1 Hastelloy Pan Dryer
- 1 Stainless Steel Pan Dryer
- 1 Hastelloy Pressure Filter
- 1 Hastelloy Filter-Dryer
- 1 Centrifuge
Verona, Italy - Facility EquipmentPilot Plant
- 100L glass-lined reactor
- 100L Hestelloy reactor
- 200L Hastelloy reactor
- 400L Hastelloy reactor
- Three closed mobile pan/pressure filters, mobile pumps and flexible pipes
- One mobile filter dryer
- Two tray dryers
Scale Up Laboratories - 10 reactor modules dquipped with 2-20L three walss glass reactors ranging from -80 to +150 degrees C
- Several Process Analytical Technologies (PAT)
- Filter dryer equipped with isolator
- 1-5-20L Hastelloy hydrogenator
- Multi-kilo Biotage 150L Chromatography System
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Hyderabad, India - Facility Equipment11 Reactors in Oncology area - 50L-250L in Stainless Steel and glass-lined
- 1L-20L all glass reactors
4 Reactors in Non High Potents area - (2) 200L Stainless Steel reactors
- (2) 100L glass-lined reactors
17 Reactors in Intermediates area - 50L-250L in Stainless Steel, glass-lined and glass reactors
Isolation can be carried out in tray dryers, fluid bed dryers, isolators or rotary cone drers Hydrogenation area - 750ml and 2L Autoclaves in Hastalloy and Stainless Steel
- 25L Hastalloy Autoclave
- 100L and 200L Stainless Steel Autoclave
Column Chromatography area at Pilot Plant (Hyderabad) with column lengths ranging from 50mm up to 1200 |
Visakhapatnam (Vizag), India - Facility Equipment Nearly 200m3 of cGMP reactor capacity with flexible isolation, drying and finishing suites comprising of:- 10 Reactors in dedicated Oncology Building
- 500L-2000L Stainless Steel and glass-lined reactors
- 88 Reactors in General Chemistry Building and Hazardous Chemistry area
- 500L-7500L Stainless Steel and glass-lined reactors
- Rotary Cone Vacuum Driers SS-316 (1000L)
- Vacuum Tray Dryers (12, 24, 36 trays)
- Fluid bed dryer 925kg
- Hastelloy ANFD with Isolators (250L and 300L)
- 4x Multimills SS-316 (50-250kg)
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