NOVA LABORATORIES LIMITED – MIA(IMP) 13581

1.1 — Sterile Investigational Medicinal Products

1.1.1 — Aseptically prepared (processing operations for the following dosage forms)

1.1.1.4 — Small volume liquids

1.1.1.5 — Solids and implants

1.1.1.6 — Other aseptically prepared products

1.2 — Non-sterile investigational medicinal products

1.2.1 — Non-Sterile Products (processing operations for the following dosage forms)

1.2.1.1 — Capsules, hard shell

1.2.1.6 — Liquids for internal use

1.3 — Biological investigational medicinal products

1.3.1 — Biological medicinal products

1.3.1.2 — Immunological products

1.3.1.3 — Cell therapy products

1.3.1.4 — Gene therapy products

1.3.1.5 — Biotechnology products

1.3.1.6 — Human or animal extracted products

1.4 — Other investigational medicinal products or manufacturing activitiy

1.4.2 — Sterilisation of active substances/excipients/finished products:

1.4.2.1 — Filtration

1.5 — Packaging

1.5.1 — Primary packaging

1.5.1.1 — Capsules, hard shell

1.5.1.6 — Liquids for internal use

1.5.1.11 — Semi-solids

1.5.2 — Secondary packaging

1.6 — Quality control testing

1.6.1 — Microbiological: sterility

1.6.2 — Microbiological: non-sterility

1.6.3 — Chemical/Physical

1.6.4 — Biological