Environment, Health and Safety Policy

Aktinos’s goal is to create a safe and healthy workplace. No job is so important that it cannot be done safely and without adverse environmental impact. Our aim is to have zero incidents.

Therefore, we operate with the greatest care for the safety, health and the environment for our employees and the communities we engage with. Our activities are supported by a management system that includes policies, procedures, training and feedback, which ascertain that we comply with laws and regulations applicable to our operations and in accordance with our own corporate standards and codes.

THE ENVIRONMENT AND THE ECONOMY ARE REALLY BOTH TWO SIDES OF THE SAME COIN. IF WE CANNOT SUSTAIN THE ENVIRONMENT, WE CANNOT SUSTAIN OURSELVES.

The analytical department at Aktinos offers unique integrated analytical capabilities and expertise, delivering complete and high-quality packages of analytical services for drug discovery and development, customised for each phase – from early definitions to analytical tech transfer, in a fully validated GMP environment.

Aktinos Pharma analytics benefits from a broad range of analytical technique expertise and capabilities to provide for any development phase and API process development.

The strong Analytical chemistry team at Aktinos works closely with the Chemical Development and Tech-transfer teams and support all phases of development. Analytical lab is equipped with latest sophisticated analytical instruments like HPLC, GC-HS, IR, UV, Polarimeter, Automated titrator, LCMS etc.

Capabilities

  • Analytical method development for raw materials, intermediates and API
  • Method validations, Method verification and Method transfer
  • Impurity profiling – Synthesis, isolation and characterization
  • ICH Stability Studies & Support for Regulatory filing and approvals (CMC, DMF)
  • Complete evaluation and characterization of polymorphs
  • Strong and close cooperation with external partners for structural characterization equipments (NMR, Prep HPLC, PXRD, DSC, TGA, ICPMS), BET and Microbiological studies.

Manufacturing Capabilities

Aktinos Pharma involved in the manufacturing and supply of:
  • Key Starting Materials (KSMs)
  • Registered Starting Materials (RSMs)
  • Key GMP Intermediates
  • Commercial-scale APIs

Aktinos Pharma has the following manufacturing sites available for catering to the customer requirements.

CGMP Manufacturing Plant – Unit I: Hyderabad, India (Suitable for advance Intermediates, KSM, RSM)

Over 36 KL of reaction volume consisting of SS 316 & GLR reactors and Glass assemblies

  • Temperature range of – 80 ° C to +250 ° C
  • Capacity ranging from 50 L to 5000 L

Hydrogenation Plant:

  • Capacity : 1000 L, 1500 L
  • Temperature range: – 5 ° C to +150 ° C
  • Pressure up to 10 kg/cm2

CGMP Manufacturing plant – Unit II: Visakhapatnam, India (Suitable for advance Intermediates, KSM, RSM, API)

Over 228 KL of reaction volume consisting of MSGL, Glass assemblies and SS 316 reactors

  • Temperature range of – 80 ° C to +180 ° C
  • Capacity ranging from 50 L to 8500 L

Hydrogenation Plant:

  • Capacity : 250 L, 1000 L, 2000 L
  • Temperature range: – 5 ° C to +135 ° C
  • Pressure up to 20 kg/cm2
All manufacturing facilities well supported with appropriate:
  • Filtration Equipments: Centrifuge, Nutsche filters, Agitated Nutsche filter
  • Post Production Equipments: Tray Dryer, Vacuum tray Dryer, Fluid bed dryer, Multimill, Sifter, Micronizer, Blenders
  • Supporting Utilities
  • Solvent recovery plants
  • QC equipped with modern Analytical equipments