At present Incepta has one fully operational plant at Zirabo, Savar, Dhaka (Zirabo plant) and another at Dhamrai, Dhaka. The second site is currently under development and several projects of finished formulation unit are being set up.
The Zirabo manufacturing plant is located about 35 Km north of Dhaka City and covers an area of land about 15,000 m2. The total built up production area is about 300,000 square feet. Currently the plant consists of a general purpose manufacturing building, a dedicated cephalosporin manufacturing building, and a specialized manufacturing building for the production of lyophilized products, insulin and amino acids in addition to several floors dedicated to the production of solid dosage forms- tablets and capsules. A newly built liquid and semisolid manufacturing building is also in operation at this site. The site also houses a warehouse for raw, packaging and finished goods. To meet the increasing demand from domestic as well as overseas markets, another warehouse is currently under construction with three times the capacity of the existing one. A separate multipurpose building houses the Research & Development lab along with the canteen facility. At present all the products are coming from this plant at Zirabo.
Manufacturing and packaging operations are carried out according to the validated methods through systematically qualified machines with full documentation at all stages of operations.
The production sites follow the cGMP guidelines for environmental requirements of the manufacturing and packaging area, as well as comply with the EHS requirements.
Highly sophisticated HVAC systems are used to condition, monitor and supply clean air to the working zone according to the manufacturing zone concept, capture and control any dust, vapor, gas or fume generated, as well as treat re-circulated and/or exhausted air. Temperature and moisture level are maintained at the desired level through this system.
Design of the room and air-conditioning systems ensure:
- Prevention of contamination of the product.
- Protection of the environment.
- Protection of people.
- Prevention of the ingress of vermin, insects, birds etc.
There are different environmental zones maintained within the manufacturing area.
Training programs take place on a regular basis according to written plan. Personnel at all levels undergo general cGMP and Technical Training appropriate to perform their job satisfactorily.
Purified water and water for injection plant and distribution systems are designed to maintain the water quality according to the relevant requirements and state-of-the-art engineering design which include e.g. 24 hours run circulation loops, smooth interior surfaces, adequate materials, minimum flow rates.
At the Zirabo plant the following activities are carried out
- Pharmaceutical Manufacturing – processing and packaging of pharmaceuticals to supply to the local market and for Export to 3rd parties. Approved suppliers supply the active substances used in manufacturing. Most of the auxiliaries used for production are bought from approved third parties.
- Logistics, Warehousing – Storing of raw and packaging materials to meet the requirements of production and also storing and dispatch of finished products as per concept of Good Storage Practice of pharmaceuticals.
- Engineering/Industrial Engineering – In line with pharmaceutical production, health safety and environmental protection, infrastructure maintenance, machinery and other maintenance. Effluent treatment and safe disposal of pharmaceutical waste.
- Quality Assurance/Quality Control – Quality Control of pharmaceuticals, raw and packaging materials, reagents and chemicals, plant and personnel hygiene, method and process validation, and overall quality assurance of pharmaceuticals.
- Research & Development – Formulation development and adaptation for scale up production with process validation, method validation in collaboration with QA/QC. Stability study and shelf life determination of pharmaceutical products. Reformulation/improvement of existing formulations in line with new/advanced technology.
- Plant HR/Administration – Support different units of the plant for HR related issues, general services, general logistics and administrative issues.
The following product forms are manufactured on site:
A. Sterile Products:
- Liquid dosage forms (LVP & SVP, Terminally sterilized and aseptically filled ampoule)
- Eye Drops
- Solid dosage forms (Solid fill, Dry vials and Freeze-Dried Products)
B. Non Sterile Products:
- Liquid dosage forms (Oral Liquid, Nasal Solution, Nasal Spray)
- Semisolid dosage forms (Creams, Ointments, Gels)
- Solid dosage forms (Tablets, Capsules, Powders, Granules)
C. Biological Products:
- Aseptically prepared injectables: Erythropoetin, Enoxaparin, Insulin, Insulin Glargine (rDNA), Filgrastim
D. Cephalosporins (Dedicated manufacturing facility):
- Solid dosage forms (Tablets, Capsules, Powder)
- Sterile Powders (Aseptically filled vials)