Oman Pharmaceutical Products Co. L.L.C.
 
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Oman Pharmaceutical Products Co. L.L.C.
Facility Overview Capacity & Capabilities Non Antibiotic Unit Antibiotic Unit Hormones Module
 
 
Facility Overview
 

Salient features of the facility are :

  • Unidirectional Flow of Men & Materials
  • High Level of Product Protection from contamination & cross-contamination
  • Use of gravity/vacuum transfer systems for the product movement and high degree of automation for product & personnel safety.
  • HVAC System designed to meet the requirements of OPP’s Zone concept Policy, e.g. Pressure Differentials, Filtration Rating, Temperature & Humidity control. HVAC system is provided with monitoring and alarm system by linking to Control and Monitoring System.
    Men - material flow : Uni linear man and material movement for the starting and finished products ensure prevention of mix-ups. The plant is designed in “U” shape for the movement of uni linear material movement for prevention of cross contamination.

Zone concept :
The facility is divided into three zones for areas demarcation. Yellow zone after primary change, orange and red for secondary change. Red is for segregated areas like Steroids, Hormones and Antibiotics. By having zone concept the contamination of starting materials and finished products are avoided .These are validated periodically to ensure prevention of cross contamination.

Manufacturing capabilities include tablets, capsules, liquids, powders and topicals which are packaged, stored, batch released and distributed worldwide, using the expertise of our Qualified Persons on site.

In addition to the manufacture of our own developed products, Oman Pharma offers contract manufacturing of solid dosage forms, liquids, topicals and powders. Quantities range from lab scale to pilot plant stage through to commercial production.

We also have the ability to handle controlled drugs.


Validation :
validation activity is a journey and not a destination through out the lifecycle of a product, process, equipment and facility. Validations are carried out as per defined procedure for processes, new formulas, changes to the existing procedures. Re-Validations are carried out as per schedule to ensure that the processes are achieving the intended use.


Following non-sterile dosage forms are manufactured at the OPP, Salalah site :

  • Solid Dosage Forms - Tablets and Capsules
  • Multi Dosage Forms - Dry powder Syrups
  • Oral Liquids – Clear Syrups, Suspensions, Emulsions, Elixer
  • Semi-Solid Dosage Forms - Creams, Ointments, Gels & Lotions etc.

Certifications :

  • MHRA-UK
  • TGA-Australia
  • RVO-Germany
  • GCC-DR

Regulatory & Documentation :
Today’s fiercely competitive and highly regulated markets demand rigorous design and management of product development and registration strategies for success.

Critical time is saved in getting the product to the market in optimum period for submission to the Regulatory authorities. At Oman Pharmaceutical Products Co LLC, a team of highly qualified scientists and technical professionals work as part of Regulatory Affairs.


Quality Assurance and Documentation Department services include :

Regulatory & Documentation
  • Domestic and International registrations.
  • Technical package containing Pharmaceutical, Clinical and Therapeutic updates.
  • Site Master File, Abbreviated Applications and Dossiers.
  • Liaison with regulatory authorities for audits, inspection and technical queries.

Brief Description of Water Purification System :
The Water Purification System is designed to process and purify the feed water supplied by Raysut Industrial Authorities. Click here to know more...


Safety Health Environment :

As a responsible corporate citizen, Oman Pharmaceutical Products Co. LLC family believes that maintaining the ecological balance is as important as business achievements and that success is not acceptable at the cost of disturbing the environment. Click here to know more...