M.P Presentation

MISSION PHARMACEUTICALS

Mission PharmaceuticalsUnder the Umbrella of

Universal EnterprisesCompany Presentation

January 2016

Our vision & Mission

• Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

INDUSTRY OVERVIEW Pakistan's Pharma

• Pakistan's Pharmaceutical Industry worth approx US$1.18 billion with an annual growth rate of 9.4%

• Total 1000 Pharmaceutical Manufacturers - 30 Multinationals & 970 National Companies

• The top 50 companies enjoy 83.5% market share and the top 100 companies have 94.0% market share. There are 20 multinationals in the top 50 companies

• 5. Market Share Market share Multinationals : 53.3% National Companies : 46.7%

• Leading the way in many aspects for next 25 years.

• The basis of balanced-capacity production is the tentative marketing plan for next 10 years.

THE PLANT OF MISSION PHARMACEUTICALS

PRODUCTION PLAN

• Production focuses will not only to cater the domestic demand but will provide toll services to Multinational National Companies and local groups. Spade work for export business is underway.

FACTORY AREA

• The covered area of the Factory is 12000 sft. With Ground + First Floors. + Service Floor.

• The total built-up area of the three floors is 58,000 sft.

• Production sections include Ampoules and Dry Powder Injection in the Sterile Area, while in the oral section Tablets, Capsules, Liquids and Dry-Powder Suspensions are to be manufactured.

• Site Master File (SMF) and Validation Master Plan (VMP) Preparation is Underway.

• The State of the Art facility shall start its commercial production in the first quarter of 2016.

PRODUCTION SECTIONS

ORAL PRODUCTION

• Tablets, Capsule, Dialysis Section will be Manufactured and Packed at the Ground Floor.

• The Total Built-Up Area is 12, 000 sft. • All the rooms have 8.6 ft. Ceiling height, except Liquid

and Dialysis Manufacturing area, where height is 14 ft. • Doors are made of SS/Glass with matching handles. • Windows are of 6 mm glass with SS frames of the wall. • All the right angles are coved. • Mosaic flooring• Epoxy in Dialysis Powder.

CHANGE ROOMS

• The Male and Female Change Rooms of Packaging and Manufacturing personnel are separate and dedicated, controlled & monitored through Access Control System and different Uniform Color Codes.

• Separate change room has also been provided for the visitors. The will be used as Emergency exit.

EQUIPMENTS/MACHINERY

• The selection of key equipments like Fluid Bed, Drier, Tray Drier, Mixer, Blenders, Compression, Vacuum Transfer System, Thai Coata, Blister Packaging, Encapsulation, Dry Powder, Filling/Sealing/Labeling and Liquid Section Machines is based on its suitability in terms of capacity, functional efficiency, GMP features, change - over and maintenance, each with built in programmable logical controllers.

CAPACITY OF EQUIPMENTS

• 500 Kgs Granules can be blended in a single shift• 0.5 Million Tablets can be compressed/coated in a

single shift .• 0.5 Million Tablets can be blistered in a single shift• 0.1 Million Capsules can be filled in a single shift.• 4,000 liters of liquid production can be achieved in a

single shift. • 15,00 Packs of dry suspension can be filled, sealed,

labeled and packed in a single shift.

• Close Circuit TV. PA System, Intercom, Network cabling, Insecticuters, Air Curtains and Emergency Lights are provided at the required points and places.

• All the stainless steel drain ports in the production area have been fitted with air breaks to avoid back flow or foul smell. High quality PPR piping is used for the process drainage system.

DISPOSAL

• Disposal of process wastes and social wastes have separate drainage system, connected to the respective septic tanks and after due treatment, the liquid waste shall be discharged into the outside sewerage line.

POWER SUPPLY

• Main source of power generation is local electric supply; however a Stand by Generator of required capacity has also been installed for uninterrupted production operations.

• A small generator of required capacity has also been provided for critical equipments and air handling system of Injectables clean rooms, to be used after normal working hours in case of power outage.

HVAC SYSTEM

• Split Type Package Unit have been installed for the cooling system in the production wings and Quality Control area.

• Dedicated Air Handling Units of required CFM and SP have been provided in all the manufacturing areas with appropriate filtration system to get the required air purity.

HVAC SYSTEM

• Required Air Changes/Hour shall be maintained in every area.

• Required Temperature and Humidity shall be maintained as per product requirement.

• All the ducting work has been completed using required SWG, appropriate insulation, cladding and Anti Fungus paint. Low level return ducts are used as per requirements.

WATER AND OTHER UTILITIES

• Purified Water System have been installed with SS 316.

• A comprehensive Compressed Air Network has been designed with Compressors, Specific Monitoring Program to check the quality of Compressed Air shall be in place.

STEAM

• Steam shall be produced from Steam Generators with high quality piping work is in process.

• Installation and Operational qualifications are underway for all the machines and equipments.

ENTERPRISE RESOURCE PLANING (E R P)

• A Sophisticated and Hi – Tech Data based Software (ERP) is in designing process to run all the activities of the factory.

STERILE PRODUCTION

• Sterile liquid Ampoules and Dry Powder Injection shall be Manufactured and Packed at the Second Floor.

• The Total Built-Up Area for these operations is 14, 000 sft.

• All the right angles will be coved.• Epoxy Flooring will be carried out in the entire

production area with surrounding corridors.

Sterile Production Output, Based on Single Shift x 200 Days/Annum

• 5Million Ampoules (per annum) of different sizes may be produced

• 2Million Bottle packs of Vials may be produced per annum, ranging from 2ml to 100 ml.

QUALITY CONTROL LABORATORY:

• Quality Control/Assurance and Micro lab is located at the first floor.

• Separate Instrument Room, Balance Room, fuming area, packaging materials testing area, documentation room, stability room .

• Separate changing rooms have been provided for entering into the Sterility room.

• The built-up area is 4500 sft.

Q.C LAB

• The lab will be equipped with Hi-tech equipments and instruments like :-

• HPLC• UV/Spectrophotometer• Dissolution Apparatus• Polarimetre• Climatic Chambers• Incubators and Ovens• Laminar Flow Hoods• Refractometre etc etc

Q.C LAB

• Reference Samples room is equipped with Imported Shelves where Finished Products and all incoming Raw Materials sample will be stored upto the expiration plus one year of the batch where that particular raw material was used.

• Lab is also equipped with Micro section of the existing products .

WAREHOUSE:

• The total built-up area of the warehouse is 10,000 Sft, with the roof height of 14ft in the raw material store, packaging material store,

• Goods Reception Zone, handling area, incoming quarantine section, sampling section, stores and cold room. Storage areas will have adequate metallic racks , for pallets made of Plastic/Quarantine and Finished Goods Store.

ENGINEERING/TECHNICAL AREA:

• Engineering/Technical Area shall comprise of Offices, workshop, AC plant room, Steam Generator rooms, Dust extraction system, Air Handling Units, Oil Free Compressors. Total built up of this section is 23,300 sft.

ADMINISTRATION BLOCK:

• Comprise with entrance lobby internal reception, Factory Manager/Secretarial offices, HR/Admin offices, visitors waiting on the ground floor.

• Separate Cafeteria, Prayer rooms for male & female, Guard rooms, Drivers room, shall be built on the plot facing the factory. Covered area is 7,200 S. Feet.

THANK YOU