Contract Manufacturing

Sama Biotech is an integrated contract manufacturer of Non beta Sterile injectables (Dry/ Liquid), Non beta Tablets and Capsules.

  • Leading contract manufacturer of Clinical to Commercial Sterile injectables.
  • Serving global leaders in pharmaceutical industries.
  • Offering key services including full testing, regulatory support, customize secondary packaging and stability.

Manufacturing Facilities

(Capacities) per Month

  • Dry Injection (Non Beta) 20 lacs (approx)
  • Liquid injection 30 lacs (approx)
  • Tablets (Non Beta) 1cr (approx)
  • Capsule (Non Beta) 1.2 cr. (approx)

Area

  • 100% panel work 360 degree 20,000 sq. ft.
  • 100% area with epoxy flooring inside the building.
  • Built as per WHO norms.

All manufacturing facilities are based on PLC and are Automized.

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Quality Assurance

  • Sama Biotech conforms to all local and National pharmaceutical bodies thereby providing pharmaceutical products of the highest quality. The plant design meets the World Health Organization (WHO) requirement and GMP standards which further ensures that all products are consistently produced and controlled according to quality standards.
  • QA department is well equipped with qualified persons & necessary equipment's.
  • QA is having valid systems with validated process.

Quality control

  • Quality Control Laboratory’s determination comes from perseverance and a strong desire to contribute to the betterment of patient’s lives by high quality standards of finished products.
  • Quality Control Laboratory is equipped with latest sophisticated equipment's & machines. Such as HPLC, FTIR, UV, Dissolution apparatus, Disintegration test apparatus, Friability test apparatus, Stability chambers, muffle furnace & LOD oven etc.
  • QC Laboratories is consists of different sections; wet chemistry, Microbiology & Instrumentation section.
  • QC has stability chambers for stability studies.
  • Quality control department have separate well equipped microbiology section.
  • Microbiology section has separate AHU, sterility/ MLT testing facility with vertical and horizontal LAF, Bio-safety cabinet, Incubators and BOD incubator, separate autoclave (double door autoclave for sterilization and vertical autoclave for discard) etc.

  • Production team

  • Production is run on strict accordance with international and local quality management standards and systems.
  • The plant is having two different blocks: General Production Block( Tablet Capsule) & Sterile Block (Liquid & Dry powder injection)
  • Ground Floor: The Ground floor consists of warehouse for Raw & primary Pkg. materials with dispensing & sampling booth; well equipped Quality control department Having HPLC, FTIR, UV, Dissolution apparatus, Disintegration test apparatus, Friability test apparatus of different renowned make.
  • First Floor: The first floor consists of tablet & Capsule. Tablets Department is well spaced with three granulation stations, blending stations, two compression stations, Auto coater; the packing departments is well equipped with Blister machines, strip machines and Alu-Alu machine
  • Second floor: The second floor is consists of sterile injection (Dry Powder and Liquid) manufacturing facility.
  • Third floor: The third floor consists of Quality Assurance department, Utility area Stability chamber room, Retention sample room & Engineering office.
  • Fourth floor: The fourth floor consist of Utility equipment such as Chiller compressor, Boiler , Purified water generation system & WFI (Multi column)
  • The manufacturing plant provide a intelligent building climate control system (HVAC) to protect product integrity
  • HVAC system supplies clean air to all manufacturing & critical primary processing areas
  • Supplied clean air is filtered from Initial filter, intermediate filter & terminal filtration is through HEPA (0.3micron)
  • Sterile production area & HVAC system is completely separated from General
  • production block.
  • PWS is having dedicated loop system for each floor.