A Leader in manufacturing of Pharmaceutical Ingredients

Bioaltus Labs has a state-of- the art API manufacturing facility at Paithan, Aurangabad, Maharashtra. The plant is spread over a plot area of 45000 sq.ft.

  • GMP/ Production Block
  • Intermediate Manufacturing Block
  • Quality Control
  • Quality Assurance
  • Microbiology Lab
  • Warehouse Block
  • Utility Block
  • Effluent Treatment Plant
  • Administrative Block
  • Pilot Plant Block

GMP / API Production Block

The GMP Block shall be built with three key points in mind: Efficiency, Safety and Environment. Our compact, yet robust factory complex shall have all the key ingredients for a successful manufacturing unit. Our API manufacturing facilities shall be operated in accordance with cGMP guidelines as well as requirements of International Regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA, KFDA, COFEPRIS.

The Flexible manufacturing infrastructure and multipurpose facilities will allow the expansion of product range and change in product mix in response to changes in the customer demand. It shall enable us catering to customer requirements ranging from Gram, Kilo level to Commercial production in multi tons.

Built to GMP requirements, our production lines uses the best of breed equipment including a fully qualified HVAC system including full control of temperature, humidity and room pressure which ensures the right environment for quality manufacturing.

The facilities at the plant includes

  • Containment class OEB3
  • Capabilities to handle pressurized reaction up to 25 kg/cm2
  • Capability to handle reactions from -20°C to +120°C
  • Glass Lined Reactors
  • Stainless Steel Reactors
  • Hydrogenator
  • High Vacuum Pumps
  • Different type of filtration systems such as Centrifuge Machines, Nutsche Filter, Leaf Filter
  • Different type of Drying systems such as FBD, VTD, ATD, ANFD
  • Multimill, Vibro Shifter, Blenders

Utility Block

Our utilities shall be housed in a separate building –Utility Block to ensure that these critical aspects of the facility can be effectively maintained and serviced by our dedicated staff.

  • HVAC System comprising of 10 AHUs

  • Chilling Unit

  • Boiler

  • Compressor (oil free)

  • Water Purification System

  • PLC controlled Purified Water System

  • HVAC System comprising with HEPA filters

  • Brine plant (-25°C )

  • Generator system

  • Thermic fluid system

  • Nitrogen distribution system for interstation

Quality Control / Quality Assurance Lab

Our Quality Control Laboratory will be our advanced, accredited research facility, delivering end to end testing solutions of raw and processed material. Our facility will be geared to conduct high intensity quality control testing in both a Wet and Dry Analytical conditions. Our array of essential equipment for Chemical Analysis, Laboratory testing, Microbiology Laboratory, and Instrumental Analysis Laboratory include:

  • HPLCs with Auto Sampler (UV & PDA detectors)
  • GC head space with auto Sampler
  • FTIR
  • UV Spectrometer
  • Stability chambers as per ICH guidelines

Microbiology Lab

Our lab is staffed with trained and qualified analysts to oversee products in accordance with GLP and GMP standards and it is facilitated with:

  • TOC Analyzer
  • Auto Titrators
  • Dedicated AHUs
  • Digital Polarymeter with Temperature controller
  • Laminar Flow station
  • ISO Class areas with Incubators
  • Autoclave & Bio safety cabinet

Effluent Treatment Plant

It includes physical, chemical, and biological processes to remove physical, chemical and biological contaminants. Its objective is to produce a waste stream including solid waste suitable for discharge or reuse back into the environment. This includes below:

  • ETP setup with complying with the ZLD requirements
  • 2 ATFD Unit
  • MEE Unit
  • Reverse Osmosis