Contract Manufacturing

Cytoxic Finished Dosage Formulation @Chemi Pharma Ltd in Malta

Chemi Pharma, subsidiary of Chemi SPA, is a pharmaceutical company that delivers cytotoxic injectable Finished Dosage Formulation complying with international pharmaceutical standards: EMA (Europe), FDA (USA) and PMDA (JP)

Chemi Pharma (Plant start-up foreseen 1Q 2016) is developing a comprehensive portfolio of : “fully in-house developed” generic oncology products: Chemi SPA’s Products are sold worldwide in cooperation with Sales and Marketing team of key global players.

Chemi Pharma will act as well as CDMO offering development and manufacturing services to clients and partners internationally.

CDMO service is characterized by customer oriented approach, allowing a high level of flexibility to fulfill customer’s needs and standards. Tailored development, turnkey package of analytical services, support drug development process will complete the services offered.

  • High speed filling line in Class A under isolator (SIP/CIP)
  • 200 L Stainless steel compounding vessels
  • Cytotoxic injectable solutions (aseptic process and terminal sterilization) and freeze dried powders in glass vials
  • Vials size from 10 to 100 mL
  • 10 m2 Freeze-Drier (batch size ranging from 15000 vial for the 10R size – to 4500 vials for the 50H size)
  • Lyophilization process with solvents feasible
  • FLEXIBILITY (BATCH SIZES, FAST TURN AROUND)
  • STATE-OF-THE-ART MANUFACTURING FACILITY AND EQUIPMENT
  • ON-SITE ANALYTICAL SERVICES
  • MANUFACTURING SUPPORT WITH STRONG EXPERTISE
  • Process Development, Optimization and Validation
  • Analytical Methods Development and Validation
  • Quality and compliance
  • Commercial batches
  • Packaging and labeling
  • Cold storage
Pre-Filled Syringes