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What we do
Latina Pharma is a full-service contract development and manufacturing organization (CDMO) for the creation of APIs, pharmaceutical products and associated packaging services. We have over 35 years of experience in the field of API development that we make available to our partners and their pharmaceutical productions, enhancing their brands around the world.
A motivated staff, with great passion and long experience supports our customers during all phases, from the beginning of the development of the API by QbD to the finalization of the process, making our experience in stability studies available, accelerated studies, validation and method development. A dynamic company is essential to improve the products of its partners and to realize their projects, through a production process that ensures the best solutions for the business, thanks to great capabilities and skills.
CAPABILITIES
Onco
sterile
160/230
BATCHES
Capsules
150/200
MILLIONS
Tablets
40
MILLIONS
Tablets
(control release)
40
MILLIONS
API
manufacturing
GENERAL OVERVIEW
Sterile Cephalosporines
Potential capacity:
more than 20 tons
Oral Monobactams
Potential capacity:
more than 20 tons
Sterile Monobactams
Potential capacity:
more than 20 tons
FDF
manufacturing
GENERAL OVERVIEW
Sterile
Oncologic Production
Manufacturing Equipment
Suite I
• 6 dissolution vessels from 50 L to 1,150 L
• Production speed of about 150 vials / minute
• Vials size from 5 to 200 mL
• Lyo-1 with 35.65 m2 (18 shelves)
• Lyo-2 with 27.5 m2 (15 shelves)
Manufacturing Equipment
Suite II
• 2 stainless steel dissolution vessels 120 L / 400 L
• Production speed up to 300 vials / minute
• Vials size from 10 mL to 100 mL
• Lyo-1 with 27.9 m2 (15 shelves)
Oral
Oncologic Production
• Granulation capacity: from 15-30 L/batch to 180-420 L/batch
• Tableting capacity 10.000 cps/h
• Capsule Filling 100.000 pcs/h
Sterile Cephalosporins
Department
• Production speed up to 300 vials/minute
• Vial size from 13 to 77 ml
Packaging
GENERAL OVERVIEW
Sterile
Oncologic Production
• Vial Packaging Line
• Automatic Vial Packaging Line
• Manual Serialization Station
• Vial Labelling Machine
• Ampoules Labelling Machine
Sterile
Cephalosporine Production
• Vial Packaging Line 1- Vial Labeller
• Vial Packaging Line 2 – Vial Labeller
• Vial Packaging Line 3 – Vial Labeller
• Case Stamper
• Semi – Automated Serialization Line
Oral
Oncologic Production
• Bottle Packaging Line
• Blister Packaging Line
• Datamatrix System Antares Vision – Print & Check
Quality Control Laboratory
Equipment
• HPLC with UV, DAD, RI, ELSD, MS detectors
• IC
• GC-HS capillary and packed columns
• Dissolution
• Spectrophotometer UV, IR, NIR, atomic absorption, ICP and RX
• Flame Photometer
• HIAC, Microscopy (optical and stereo)
• Particle sizing Laser and scattering
• Amino acid Analyzer
• TOC
• Titrator;KF, Polarimeter; refractometer
• Isolators & VHP
• Autoclave & Ovens
• BET, Sterility testing system
• Thermostatic Units, Refrigerators, Freezers
• Climate rooms for all conditions required by ICH
• X-ray diffractometer
• Biohazard hoods
• Leak tester for the CCIT
Analytical Testing
• Vial Packaging Line 1- Vial Labeller
• Vial Packaging Line 2 – Vial Labeller
• Vial Packaging Line 3 – Vial Labeller
• Case Stamper
• Semi – Automated Serialization Line
Via Murillo 7
04013 Sermoneta – LT
Italy
Tel. +39 0773 3101
info@pharmalatina.com
