Production
Kleva cooperates with many companies worldwide, producing pharmaceutical products on their behalf.
Our two facilities in Athens-Greece operate in full compliance with the
European standards (EU GMPs, EU GSPs, EU GDPs) with regards to
development, production, quality assurance, storage and distribution of
medicines for human use. Compliance strictly according the GMPs
specifications, the WHO regulations issued by the National Organization for
Medicines (EOF), all GMP related audits received annually by EU (GMP-
regulated) or non-GMP regulated countries, as well as according
ISO 9001-2015 and a EUGMP Certificate.
Our two facilities in Athens, Greece, operate in full compliance with the
European standards (EU GMPs, EU GSPs, EU GDPs) concerning
development, production, quality assurance, storage, and distribution of
medicines for human use. Compliance strictly according the GMPs
specifications, the WHO regulations issued by the National Organization for
Medicines (EOF), all GMP-related audits received annually by EU (GMP-regulated) or non-GMP-regulated countries, as well as according to ISO
9001-2015 and a EUGMP Certificate.
- Implement and industrialize in production and in quality control
- Compliance with GMPs
- Observance of the timing for supply, launch and registration
- Alignment with the budget and identify sources of costs optimization.
- Thorough communication to our customer of project status.
Commercial manufacturing capacity includes production of medicinals, Food Supplements, medical devices and Health & Beauty products in the following forms:
solid dosage forms: various tablet forms (plain, coated, controlled release), capsules, granules in sachets and jars.
semi-solids: creams, ointments, gels
liquids: oral solutions (syrups, elixirs and suspension in bottles, solution in drops and monodose vials) and liquids for external use
nasal preparations
small and large volume parenterals injectable vials and ampules (by sterile filtration or by final sterilization)
suppositories
ophthalmic products
Boasting an annual capacity of more than 18,000,000 boxes, Kleva’s production lines can efficiently produce several different pharmaceutical forms. The annual production capacity per pharmaceutical form (one shift) is:
- 300.000.000 tablets
- 25.000.000 capsules
- 12.000.000 sterile amps
- 10.000.000 bottles of solutions for external use (low and high volume)
- 10.000.000 sachets
- 6.000.000 of oral solution bottles (volume up to10 ml)
- 3.500.000 nasal sprays
- 3.500.000 sterile glass vials (low volume [1-2ml])
- 3.500.000 sterile plastic vials (5ml & 10ml)
- 3.000.000 of oral solution bottles (high volume [15-200ml])
- 2.000.000 creams/gels/ointments
- 1.500.000 sterile vials (high volume [5-200ml])
An independent warehouse of 10.000 m2 is used for the handling and storage of raw materials, packaging materials and finished products.
