Ahmedabad, Gujarat, INDIA +91 79 27411 111 [email protected]

Manufacturing

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State-of-the art Manufacturing

THEO PHARMA PRIVATE LIMITED

Our mission to improve patient's lives by identifying, developing, and commercializing meaningful products that addresses unmet medical needs of the society.

The site is located without any danger from industrial fumes, pollutants, pests etc. The traffic pollution is also the least in manufacturing area. No factory producing any obnoxious odors pollutants is adjacent to the factory. The possibility of cross-contamination.

Manufacturing Process/Facility Highlights:

  • Flow of Processes from Raw Materials to Dispatch
  • Warehouse for Storage and distribution
  • Material Dispensing in RLA in a class A by D Environment
  • 21 CFR Instraments & Monitoring System
  • HVAC System with Air Control Quality
  • Zero Discharge Effluent Treatment Plant (ETP)
  • Plant Design complying with latest CGMP requirements as per PIC/WHO Guidelines
  • Well-Equipped Laboratory with modern CGLP instruments

R&D

Research & Development Center

Our primary focus is to provide quality medicines with better patient compliance by providing novel drug delivery systems. Our scientists at R&D are having a strong background of Educational qualification along with a rich experience of Research Orientation.

Some of the recent technologies developed by us are as follows:

  • Controlled Release Tablets
  • Bilayer Controlled Release Tablets
  • Sublingual Tablets
  • Mouth Dissolving Tablets

Approvals

Approvals Facility by Authorities

THEO PHARMA PVT. LTD. has a manufacturing system for Oral Solid Dosage formulation at 819/C, Village. Rakanpur, Taluka: Kalol, Dist.- Gandhinagar, Gujarat, India, The company is licensed to manufacture drugs specified in schedule C , C (1) & X as per the Drugs & Cosmetic rules 1945. Drug manufacturing license issued by Food & Drug Control Administration, Gujarat, India. The company is permitted to manufacture the Psychotropic & Narcotic formulation. THEO PHARMA PVT. LTD is WHO GMP certified company.G/25/1323 and G/28/956 issued by Food & Drug Control Administration, Gujarat, India.

Quality

Quality Management System & Quality Policy

THEO PHARMA PVT. LTD.. matches the cGMP/GLP also desire to set the system which have complied regulation offer by other country. Well established Quality management system in the organisation including identification and control of requisite documentation, records and internal audit.

To be acknowledged as a Quality, Health, Safety and Environmental Industry (QHSE) leader in manufacturer of General Tablet finished dosage forms at "THEO PHARMA PVT. LTD." meeting the needs of our customers in line with global principles of sustainable development and quality management systems. As a responsible manufacture of the finished formulations, we will continually strive to incorporate technological and methodological inputs to make our process and product consistent.

We are also committed to comply with the requirements of Drug and Cosmetic Act and system authorization agencies.

Standards

GDP & GSP

Excellent warehouses were finally upgraded to comply with WHO guidelines for Good Storage Practice (GSP) and Good Distribution Practices (GDP), our storage areas have sufficient capacity to:

  • Allow orderly storage of the various categories of pharmaceutical products.
  • Ensure dry and clean environment with acceptable temperature limits, through Records of temperature monitoring data.
  • Keep products off the floor to permit cleaning and regular inspection.
  • Permit adequate storage and handling of the products.

Production

Capacity of Production

TABLETS

  • A fully automated Manufacturing Unit.
  • All the manufacturing equipment procured from renowned Pharmaceutical machinery manufacturers is suitable for all Types of Tablets.
  • The Unit has a separate air-conditioned storage facility.
  • TABLETS Production Capacity: 25,00,000 Units per Day

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