Injectables Formulation Facility – Vials and Ampoules
Built up Area = 7,537 sq.m
Project Brief
Facility for Gonadotropins including Protein purification.
Produces both Liquid and Lyophilized Injectables in Vials and Ampoules.
Entire development comprises of Production block, Bio Lab (Animal House), Protein Purification section and ancillary areas like utility block, ETP area, Security cabin, fuel yard and Pump house.
The project is approved by UK MHRA & ANVISA.
Morison PLC - Colombo, Sri Lanka
Snapshot
Oral Solids & Liquids Dosage Formulation Facility
Built up Area = 16,728 sq.m
Project Brief
Greenfield project built on a 5-acre plot for Tablets, Capsules, Liquids (Multi-level manufacturing)
Annual production capacity of 5 billion tablets and 10 million bottles.
The plant is designed for minimum human intervention to prevent human error and includes cutting edge equipment such as the fully automated liquid manufacturing and packing lines, fully-fledged chemical and microbiology labs, separate air handling units to control environment conditions.
The following separate blocks/ Infrastructure are developed on entire plot.
Production Block
Utilities (General & Block specific)
Canteen
Substation
Fuel tank farm
Solvent tank yard
Effluent treatment plant / Incinerator
Environmental health and safety
Administration
Quality control and quality assurance.
The proposed facility is planned, designed, engineered and operated as per cGMP standards of International Regulatory Authorities like WHO, PIC/S and local statutory / regulatory guidelines.
JSC Pharmasyntez - Irkutsk, Russia
Snapshot
Oral Solid Dosage and Injectable Formulation Facility
Built up Area = 14,400 sq.m
Project Brief
The project is Design Engineered for manufacturing of products like Antitubercular, antiviral, antineoplastic, antifungal medicines, sterile dosage forms, antibiotics.
Annual Production Capacity -
Tablets: 72 Million per annum
Capsules: 396 Million per annum
Injectable: 40 Million per annum
DPI : 50 Million per annum
Targeted approvals include WHO cGMP.
JSC Eastpharm - Ussuriysk, Russia
Snapshot
Large Volume Parental Formulation Facility
Built up Area = 3,100 sq.m
Project Brief
Phase-I Built in a time span of 22 months.
Phase-II Built in a time span of 14 months.
Blood-substituting, antibacterial, antimycotic, haemostatic drugs and low-volume infusion therapy drugs.
Polyethylene bottles from 50 to 500 ml – 20 Million/annum
The facility was planned in accordance with cGMP requirements of WHO.
Engineering was design of HVAC systems for sub-zero temperatures of up to (- 32 Degrees)
The plant is being set up in a plot of about 36,000 Sq.m with an overall built-up area of proposed facility of about 10,000 Sq.m. The facility will produce Pharmaceutical products under general category. The dosage forms and their annual production volumes include Tablets (180 Million), Capsules (45 Million), Liquid Syrups (6 Million) and Ointments/ Creams (3 Million) .
Main block will house of Change Rooms, Production Area, Warehouse, Formulation Development Section, Quality Assurance, Quality Control, Administration Departments, Laundry and Technical area.
Pharmax Pharmaceuticals - Dubai, UAE
Snapshot
Oral Solids Dosage Formulation Facility
Built up Area = 8,828 Sq.m
Project Brief
The Facility is designed for manufacturing Oral Solid Dosage formulations under General category with plans to expand and set up facilities for the other pharmaceutical dosages in near future, in the industrial area at Dubai Science Park, Dubai
The facility produces 195 million tablets per year & 10 million Capsules (Hard Gelatin) per year.
The core areas are planned in Modular Panels. The Cooling system is designed considering the Distinct Cooling system.
The facility is designed in compliance with requirements of the various local authorities like DEWA, DM, and DCDA, etc. and designed to meet cGMP requirements of regulatory bodies like US FDA, EU and GCC.
The facility is designed to produce Oral Solids and Liquids and Freeze Dried Injectables.
Injectables – 60 Vials/min line.
Oral Solids – 30 kg/batch.
Single pot processor technology is used for Granulation and Drying.
Containment technology includes.
cRABS for Vial filling line & for Lyophilizer.
Isolators for Compounding and Dispensing.
The facility is EU GMP approved.
Glenmark Generics SA - Pilar, Argentina
Snapshot
Oncology : Injectables Formulation Facility
Built up Area = 10,000 sq.m
Project Brief
The facility situated on a plot of approx. 10,000 sq m. can produce 1 million units of liquids and around 1.3 million units of lyophilized concentrates.
Produces both Liquid & Lyophilized Injectables.
AHUs with Bag-In Bag-Out type filter arrangement.
Deactivation of potent liquid waste prior to discharge into the main ETP and filtering of exhaust air thru ULPA filters.
Isolators - Dispensing of Actives and Solution Compounding for Injectables. Protective suites for Personnel Protection.
The facility is approved by US FDA & Brazilian ANVISA
BDR Pharmaceuticals International ltd - Vadodara, India
