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Sr. Executive / Executive, Production; THE IBN SINA PHARMACEUTICAL IND LTD

 
Radiant Pharmaceuticals Limited
Corporate Vision
Radiant is to flourish as a leading performer in areas of activities and to excel as a caring corporate citizen committed to a high ethical standard in our business, products and services.
Corporate Mission
  • To achieve profitable growth in business endeavors as a reputed and flourishing corporate organization.
  • To ensure that the corporate performances are achieved by sincere efforts motivated to contribute through innovation and drive to deliver quality products and services with determination to lead and win.
  • To strictly adhere to the professional, social, environmental and regulatory requirements ensuring the highest possible compliance to the ethical standards and practices.
  • To emerge and continue as caring corporate citizen through providing support and services for the welfare of the employees and the society.
Core value
To improve people's health and quality of life.
History

2011

  • Export Approval from the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria.
  • ISO (9001:2008) Surveillance Audit.
  • Pharma Technical (PT) Good Manufacturing Practice (GMP) Audit by Roche.

2010

  • ISO 9001:2008 Quality Standard certified by Orion Register Inc., USA.
  • GMP Compliance, Medicines Control Authority of Zimbabwe.
  • GMP Compliance, Pharmacy and Poisons Board, Kenya.
  • ISO (9001:2008) Surveillance Audit.
  • ISO (9001:2008) Certification.
  • Renewal of Biological & Non-biological product manufacturing license.
  • For compliance with cGMP according to the Compendium of guidelines and related materials.

2009

  • Technology Transfer Initiative agreement with Roche Pharmaceutical Division.
  • Site transfer from Novartis (Bangladesh) Ltd. to Radiant Pharmaceuticals Ltd
  • Pharma Technical (PT) Good Manufacturing Practice (GMP) Audit by Roche

2008

  • Manufacturing & marketing of Radiant brands.

2006 to 2007

  • Manufacturing & marketing of Roche licensed pharmaceutical brands.
  • GMP Inspection according to AIDS Technology Transfer Initiative by Roche.

2005

  • Formation of Radiant Pharmaceuticals Ltd.
  • Licensee agreement with F. Hoffmann-La Roche Limited, Switzerland.
  • Renewal of Biological & Non-biological product manufacturing license.
Facility

Total Quality Management System

Total Quality Management (TQM) is achieved by conforming to WHO guidelines, local regulatory requirements and monographs like BP, USP, EP, etc. TQM of the firm is looked after by the Head of Quality Assurance and all departmental heads work as a team to maintain and follow the TQM system.
  • The TQM system is aimed to ensure that all processes consistently follow standard operating procedures and to assess personnel performance & competence.
  • The TQM system is designed for 'Zero Defect Product' and every employee of the company is an active team member for implementation of the TQM system.
  • Evaluation and approval of all procedures are done by the QA Department.
  • The plant has a fully equipped laboratory testing facilities and has an adequate number of competent and experienced qualified personnel to carry out the manufacturing operations as well as the necessary chemical and microbiological analysis.
  • The QA department is responsible for preparing, issuing, updating, approving, storing and controlling all GMP relevant documents.

Manufacturing Area

The facility is consisted of two buildings.
  • The capsule & dry syrup production facility is on the ground floor of building # 1.
  • It consists of a dispensing booth, dry granulation including sugar crushing, bottle washing and drying, powder filling and cap sealing, encapsulation, bottle labeling and blistering operations and a coating machine.
  • Here, processing and primary packaging areas are maintained at Class 100,000 by a separate and dedicated AHU cum dehumidifier and the secondary packaging areas are maintained and optically cleaned by Package type of air conditioning unit.
  • Tablet manufacturing facilities have been set-up on the 2nd floor along with walk-on type service void.
  • This production area consists of a dispensing booth, granulation and drying, including spray granulation, mixing and blending, compression, coating, and primary as well as secondary packaging areas.
  • This process area is maintained at Class EU-D, Roche E2 using an adequate number of AHUs.

HVAC System

  • A total number of five independent Air Handling Units (AHU) have been provided to ensure proper cleanliness class and to avoid cross contamination in the manufacturing area.
  • Each production unit has an individual HVAC system equipped with an adequate number of AHUs and Package air conditioning unit and has temperature, differential pressure, and humidity controls.
  • All environmental parameters like particle monitoring, HEPA filter integrity testing, air change rates, air pressure differentials, temperature, humidity and microbiological monitoring are checked at periodic intervals.

Quality Control System

The major activities of the Quality Control Department are:

Release of Finished Goods :

  • QC Department certifies the finished goods meet the predefined specification.
  • The final release will be preceded after QC Department certification.

Release of Raw and Packaging material :

All incoming raw and packaging materials are tested as per the approved specifications and compared with approved standards and shade cards following standard test procedures.
  • If the samples conform to the specifications, then the consignment is released.

Environmental monitoring :

  • QC department also collects samples from ETP in cooperation with the S&E engineer and carries out required tests as per respective SOPs.
  • Particle counts and microbiological counts are also carried out in the QC laboratory.
  • Potable water and purified water are also tested by the QC department.

Safety, Health and Environment

  • The site is well equipped with necessary safety measures such as an intelligent addressable fire detection system, fire hydrants and different types of portable fire extinguishers and the area is clearly identified with well-marked emergency escape routes and stairs.
  • The site has a dedicated room to ensure occupational health for employees.
  • First aid boxes are kept in appropriate places with necessary kits & medicines.
  • Periodical medical examinations of employees are done by registered hospital medical practitioners.
  • Liquid wastage is discharged to the municipal drainage system after proper treatment in the ETP. ETP water is periodically sampled and tested by our quality control laboratory as well as by the local regulatory authority and it fully complies with local regulatory requirements.
  • All solid wastage is incinerated by a third party under contract.

Warehouse

  • The warehouse is located on the ground floor and the 1st floor of a 5-storied building.
  • The warehouse is divided into three parts one for raw and primary packaging materials, one for secondary packaging materials and another one for finished products.
  • There are also three separate rooms one for narcotics, one for empty capsule shells, and another one for flavors.
Our Partners

F. Hoffmann-La Roche Ltd. Basel, Switzerland

Radiant Pharmaceuticals Limited entered into a licensee agreement in December, 2005 with the renowned innovative pharmaceutical company, F. Hoffmann-La Roche Limited, Switzerland. Now Radiant Pharmaceuticals Limited is manufacturing eight Roche Licensee brands in its own manufacturing facilities. Radiant Pharmaceuticals Limited also entered into Technology Transfer Initiative agreement with Roche for Saquinavir which is medicated to HIV patients. The manufacturing facility is fully GMP certified. Formerly, Roche used to visit RPL in every year for GMP audit. Receiving good feedback from these audits, Roche reduced the frequency of audit to once in two year.
Our Global Reach
Today Radiant Pharmaceuticals Limited has a national and global footprint, with a wide presence all over Bangladesh as well as several countries in the continents of Africa.


Radiant Pharmaceuticals Limited
22/1 Dhanmondi, Road 2,
Dhaka 1205,
Bangladesh

Tel: +88-02-9612481-6,
+8802-9660307.
Fax: +88028626253

Email: info.pharma@radiant.com.bd

Website:www.radiantpharmabd.com
 
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