ISSAR ’s USFDA compliant R&D, with a state – of – the – art production facility of 62,000 Sft was established at Genome Valley, MN Park, Hyderabad, Telangana, India in 2012.

ISSAR is using the most modern and advanced automatic equipment for the development, synthesis, purification and manufacture of peptide-based drugs. We reached to the level of manufacturing 50 amino acids length of peptides with high quality and purity standards. ISSAR has scaled up the synthetic peptide purity and yield by continued process optimisation. Today we have the capabilities to manufacture 10 Kgs peptide per batch maintaining up to 99.5% purity. ISSAR is able to manufacture and formulate the liquid and lyophilised injectables and topical products.

ISSAR is dedicated towards maintaining the highest standards in the industry. Our Quality Control (QC) group is involved throughout the entire development process, from drug substance and raw material control, through intermediate drug product testing, to finished drug product release testing and stability studies. All Quality Control activities and equipment are fully supported by approved GMP documentation. Our Quality Assurance (QA) group ensures quality management, documentation and records, materials management, laboratory controls, and cGMP. Our QA team also supports any range of validation effort, including process validation, methods validation, and cleaning validations. We ensure our facility operates to full cGMP, and our SOP systems are comprehensive, reaching every aspect of material flow.

Issar Main Building

Back-side Road

GC

Pre HPLC Purification System

East-side Road

South – side Road

Synthesis Lab & Deep Freezer

LC/MS

North-side Road

West – side Road

Shimadzu HPLC

Lyophilizer

List of Equipment used in Manufacturing Unit:

1. Auto Synthesizer
2. Lyophilizer
3. LCMS-MS Quadruple ToF
4. Preparative HPLC
5. Analytical HPLC
6. UV Spectroscopy
7. Water Purification System
8. Fine chemical Balance
9. Minicentrifuge
10. Dry Block Heater
11. Bacter Incubator
12. pH meters
13. Hot air oven
14. Hot Plate & Magnetic stirrer
15. Rotar Evaporator
16. Melting Point apparatus
17. Microfuge
18. Refrigerated Table Top Centrifuge
19. Non-Refrigerated centrifuge
20. Electrophoresis
21. Micropipettes
22. Ultra Deep Freezer (-80oC)
23. CO2 Incubator
24. Semi-Micro Balance
25. Deep Freezer (-40°C)
26. Water Bath
27. Homogenizer
28. Overhead Stirrer
29. Vertex
30. G2 Funnel
31. RB Flask
32. KF Titrator