Actavis Italy Nerviano Plant
Starting out in 1901 in Jerusalem
The company known today as Teva was established as a small wholesale drug business by Chaim Salomon, Moshe Levin and Yitschak Elstein. (They named it S.L.E after their names)
We came a long way in the last century Through mergers, acquisitions and organic growth, fueled by our commitment to patients and healthcare communities.
One of the top 10 pharma companies in the world North America Europe ROW Headquartered in Israel. Distributing medicines in approximately 100 markets around the world. Our business is divided across the United States, Europe and Rest of the World (ROW). The leading global generic company A strong specialty medicines portfolio, as well as OTC & API Commercial presence in 80 markets 58,000 employees 87 production sites 2015 revenues: $19.7 billion Manufactures: 120 billion tablets & capsules annually
Teva in Italy
Leader in the generic market 6th company in units in the retail market 3rd company in units in the hospital market Top player in the Multiple Sclerosis market in terms of patients We supply 166 packs every minute of the night and of the day in the retail market and 36 packs in the hospital market Established in 1996, is now one of the first 15 pharmaceutical companies in Italy. 6 manufacturing plants + 1 commercial office Over 1,400 employees
Teva in Italy
5 TAPI (Teva Active Principle Ingredient) sites 550 employees Total production: over 90 API Export level is on average 80-90% Nerviano Injectable final dosage production site (new from acquisition of Actavis Generics by Teva in 2016) Over 400 employees Worldwide markets are supplied
Nerviano Plant
Nerviano Plant, acquired by Teva Pharmaceuticals in 2016, was founded in the late Sixties by Farmitalia. Since its origin, the plant has always boasted a great reputation, thanks to the professionalism of its employees, to their background and to its state-of-the-art equipment and machineries. Along the years, the plant has matured a front rank experience in the manufacturing of injectable drugs.
Nerviano Plant Evolution
1969 2016 1969 Farmitalia built Nerviano plant for animal health products 1975 Farmitalia transferred the production of antracyclines to Nerviano plant 1980 Farmitalia acquired Carlo Erba forming Farmitalia Carlo Erba (FICE) 1982 FICE moved the production of all injectables products and all R&D activities to Nerviano 1994 Kabi Pharmacia acquired FICE forming Pharmacia 1996 Pharmacia merged with Upjohn forming Pharmacia & Upjohn 2000 Pharmacia & Upjohn merged with Monsanto to create Pharmacia Corporation 2003 Pfizer acquired Pharmacia 2004 Pfizer sold NRV R&D center to Nerviano Medical Sciences (NMS) 2008 Actavis acquired Nerviano Plant 2012 Watson acquired Actavis 2015 Actavis acquired Allergan 2016 Teva acquired Actavis Generics 2016, August 3 TEVA DAY ONE
Nerviano Plant Departments
Quality Control Office A98 Dept. NON-CYTOTOXIC freeze-dried and solution in vial 1 ml - 30 ml filling volume 5 ml - 40 ml vial size Solution in ampoule 1ml - 10 ml filling volume Packaging 7 packaging lines, sleeving, datamatrix, tamper evident & serialization capabilities Warehouse Workshop A200 Dept. CYTOTOXIC freeze-dried & solution in vial 1 ml - 50 ml filling volume 10 ml - 100 ml vial size solution in pre-filled syringes (PFS) 1ml long - 5 ml syringes size A100 Dept. CYTOTOXIC freeze-dried & solution in vial 1ml - 100 ml filling volume 3 ml - 100 ml vial size A90 Dept. CYTOTOXIC solution in vials 1 ml - 100 ml filling volume 5 ml - 100 ml vial size Utilities Bulk Non Cyto vials, FD, liquid, amps Bulk Cyto vials, liquid, FD, PFS Bulk Cyto vials, liquid Packaging: 7 lines
Nerviano Plant Vial Solutions & FDs
All primary packaging materials, equipment and drug solution are sterilized before entering the sterile core. The rubber stoppers, the seals, the materials and the equipment are steam sterilized. The vials are washed, rinsed with hot and cold WFI and sent directly into aseptic area through the depyrogenating and sterilizing tunnel that is shown in the picture. The drug product is filter-sterilized prior to filling. Picture shows an example of a filling line with RABS (Restricted Access Barrier System) that protects the product assuring the validated aseptic process. The dosage/fill volume is assured by in line weight check. The lyophilization (freeze-drying) of the product is carried out according to validated cycles, using our five 20 sqm shelf area freeze-dryers 4 dedicated to cytotoxic products and 1 dedicated to non-cytotoxic products.
Nerviano Plant Vial Solutions & FDs
At the end of the lyophilization cycle, the product is automatically stoppered in the freeze-drier. After unloading, the product is maintained under grade A air supply until capping. Crimping closure is assured by an integrity closure test. Sealed vials are externally washed to eliminate any trace of residue: vials cleanliness is assured by validated washing processes. 24 hours/day, 7 days/week continuous monitoring of critical parameters allows strict control of processes.
Nerviano Plant Pre-filled syringes
Pre-filled syringes filling line is installed in a crabs, with CIP/SIP and IPC weight control in line. It is equipped with formats from 1 ml long syringe up to 5 ml syringe. The line is fed with pre-sterilized syringes ready to fill, supplied in nest & tub and with ready to use plunger stoppers. The dosage ranges are from 0.3 ml to 5 ml. The filled pre-filled syringes are then automatically or manually visual inspected and once the inspection is complete they are automatically packed in blister and then in unit carton. The pre-filled syringes can also be packed in Safety Device.
Nerviano Plant Inspections
The vials and PFS are 100% automatically inspected with validated machines or visually inspected by qualified operators, in order to remove defective units. The inspected vials are statistically sampled by Quality Control.
Nerviano Plant Ampoules
The ampoules are automatically opened, filled and closed. The ampoules, collected in trays, are washed, tested for integrity and then 100% automatically inspected by validated machines that check the presence of foreign particles, the filling volume and the position of the identification ring, in order to avoid any mix-up among different products. The inspected ampoules are statistically checked by Quality Control.
Nerviano Plant Products portfolio
Strong products portfolio cover the major therapeutic areas. Injectable Cyto-Non Cytotoxic freeze dried & solution in vial Injectable Non Cytotoxic solution in ampoule Injectable biologic freeze dried in vial Injectable solution in pre-filled syringes
Nerviano Plant packaging and warehouse
The 7 packaging lines assure flexibility in secondary packaging presentations and capability to package all the products manufactured in the plant. F31 ampoules F34 vials + ampoules or vials in blister or multiple vials F35 vials F38 prefilled syringes F37 vials or vials + ampoules F40 vials F41 semi automatic / print & check multipack labelling machines ampoules/vials sleeving capabilities on F35 and F40 2 lines equipped with tamper evident (F38/F40) + standalone equipment Serialization capability available. The 5,000 pallet space warehouse is managed with a validated ERP (Enterprise Resource Planning) system. A controlled cold room is available for heat labile products. Warehouse also hosts dispensing and sampling suites where activities are carried out in class C environments.
Nerviano Plant Chemical laboratories
Analyses of raw material, finished product & stability: UV-VIS, FTIR, AAS, TITRATOR, HPLC, GC Analyses to support cleaning and process validation. Stability studies according to all ICH conditions. Photostability Studies. Analytical Method Development and Validation. Analytical Technology Transfer.
Nerviano Plant Microbiological laboratories
Analyses of raw material, finished product & stability: Sterility test in isolator, total bacterial count, microorganism identification and bacterial endotoxin test. Analytical Method Development and Validation. Environmental Monitoring. Microbiological support to Facility/Equipment Validation.
Nerviano Plant Certifications
Safe, reliable Products NERVIANO offers fast access to a wide choice of pharmaceuticals. We operate GMP-approved manufacturing facilities, with meticulous in-house quality standards within a rigorous regulatory environment, ensuring the highest quality at all times. This quality is reflected in our commercial customer base, which includes a number of leading businesses companies. Nerviano produces vials for oncology treatments, providing freezedried and solution products, as well as high volumes of cytotoxic and non-cytotoxic injectables, for worldwide sale. Offering high-quality pharmaceuticals to an extensive customer base.
Nerviano Plant Certifications
Caring for Environmental Health & Safety (EH&S) The plant is committed to protecting the environment and employees health. This is demonstrated by tangible actions, not just words. Nerviano site has achieved ISO 14001 certification in 2006 and OSHAS 18001 in 2007, providing independent reassurance that our systems meet internationally recognised standards.
Actavis Italy S.p.A. Via L.Pasteur, 10 20014 Nerviano (Milano) Italy +39 0331 583111 infoactavisitaly@actavis.com