Sumy Pharmaceuticals Pvt. Ltd.

Production
- Sumy is considered to be the biggest WHO GMP-certified pharmaceutical manufacturer in Kathmandu, Nepal. The company claims a modern facility that covers a total land area of roughly 150, 000 square feet. Its dedication to the constant improvement of its facilities ensures that all products are made using advanced manufacturing equipment at all stages of the production process from research to packaging.
- Sumy has experienced and skilled technical manpower engaged in product manufacturing. It is mainly concerned with the manufacturing of non-sterile products for pharma and dental care, which include solids, liquid orals, semi solids, and solutions for external use.
- These dosages form accounts for tablets, capsules, dry syrups, oral liquids, gels, cream and water-soluble powders. Sumy manufactures antiallergic, antiamoebic, antibacterial, anti bacterial + antifungal, antibiotic, antidiabetics, antiemetic, anti fibrinolytic, antifungal, antihelminthic, antihypertensive, antimigraine, antiseptic, antispasmodic, antiulcerant, cold & cough, cyclopegic/mydriatic, directic, diurectic/antihypertensive, ear wax remover, iron supplement, keratolytic, keratolytic + antibacterial, lipid lowering agent, lubricating eye drop, nasal decongestant, NASAID, vitamin and minerals.
- The manufacturing facility of different categories is segregated by separate HVAC systems. It has separate rooms with complete facilities for the manufacturing of pharma products. Sumy manufactures and supplies 114 products of different concentrations in the market.
- All equipment used in Sumy to manufacture are under WHO-GMP guidelines.
- Some of the equipment used includes; Fluid Bed Dryer, Mass Mixer, Vibratory Sifter, Colloid Mill, Multi Mill, Cone Blender, Rotary Compression M/C, Capsule Filling M/C, Capsule Sorting and Polishing M/C, Rapid Cota M/C or Sprayer, Blister Packing M/C, Alu-Alu Packing M/C, Strip Packing M/C, Bottle Washing M/C, Liquid Filling /Sealing/Inspection and Labelling M/C, Planetary Mixer, Semi Solid Filling/Sealing M/C, Dry Syrup Filling/Sealing M/C

Marketing

Quality Assurance
Quality Assurance system is developed for the overall systematic approach for the production of quality products, which includes implementation of various requirements in line with current Good Manufacturing Practices. The Q.A. Dept. is responsible for batch release, process validation, preparation of various documents related to manufacturing, quality control and calibration of various equipment.

Quality Control
- Medicines made with the mindset of approaching the care of patients in the same way the way they would if they were their own children.
- New cutting edge technology
- The thought of providing excellent quality medicine is shared throughout the company and employee.
- Focusing on patient.
- Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products and appropriate monitoring environmental conditions for GMP purpose.
- Records are made manually and recorded by a recording instrument, which shows that all required sampling, inspecting and testing procedures were carried out. Any deviations are also recorded in the system.
- Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures.
- All the finished products of Sumy contain active ingredients complying with qualitative and quantitative composition of the marketing authorization, are of the purity required, and are enclosed within their proper packaging and correctly labeled.
- An authorized person certifies no batch of products released for sale or supply that it is in accordance with the requirements of the relevant authorizations.
- Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.

Vendor Validation
Suppliers of critical starting materials and packing materials are assessed on the basis of their supply records. Quality control report with respect to their internal or pharmacopoeial specifications are reviewed and compared with the reports from the manufacturer/ supplier.

Self-Inspection (Audit Program)
There is an in-house self-inspection program and is regularly carried out by company’s self-inspection team.

Release for Sale Procedure
Finished products are assessed finally when the product is in final container and is ready for dispatch. This is done as per the specifications and protocols. As soon as the product is finally tested, analyst prepares the analytical report as per Quality Control Monograph.