OREX PHARMA PRIVATE LIMITED

Company Description

OREX PHARMA PVT. LTD. is a Manufacturer and Exporter of Active Pharmaceutical Ingredients (API) , Intermediates in India. OREX PHARMA PRIVATE LIMITED manufacturing unit is located at country's well known city Dombivli which is just 25 km away from the Commercial capitol "MUMBAI", India.

We have moderate manufacturing facility, Pilot Plant with analytical support to provide excellent services as per customer requirements under confidentiality Agreement.

We have ISO 9001-2008 and WHO GMP compliant manufacturing facility located in Dombivli. Our manufacturing facility is multipurpose with reactors capacities range from 2000 KL to 5000 KL.

Our manufacturing facilities are designed to manufacture a variety of APIs and Intermediates using a combination of processes. Our flexible manufacturing infrastructure enables us to expand our product range and change our product mix in response to changes in customer demand and to serve customer requirements ranging from laboratory scale research to commercial production.

We have the capability to handle several complex reactions in a cost-effective manner with scale of operations ranging from multiple, multi-product facilities with capacities varying from gram to kilograms and multi tons.

Our Infrastructure is equipped to carry out the following reactions :

1. Bromination
2. Condensation
3. Crystalization
4. Reduction
5. Hydrogenation
6. Benzylation
7. Hydrolysis
Quality Assurance

We have a strong Technical Personnel in our Quality Assurance and Regulatory Affairs. They are independent and fully dedicated towards control all the Documentation and Production Activities.

Our Q.A. and Regulatory Affairs team comprises of a wealth of experience in all areas of WHO GMP implementation, audits and compliance, Preparation of Regulatory Documentation, submission, deficiency response, updation to regulatory agencies and customers.

The prime aim of our team is customer satisfaction through continuous improvement in system as per all applicable statutory and regulatory requirements.

Quality Control

Our laboratory is well equipped with modern instruments wherein we carry out all the required tests for raw material and finished products.

All fished products tests are carried out strictly as per procedure framed by Quality Assurance Department.

Our Raw material approval are subject to stringent Quality Control methods to ensure quality finished products.
RESEARCH & DEVELOPMENT


Being R & D Driven manufacturing entity our highly skilled techno-commercial team is continuously starving in enhancing the quality and cost reduction to remain abreast with the competitive and quality conscious global pharmaceutical market.

The research facility is equipped with most of the modern infrastructure & we are capable of handling reactions involving diverse chemistry

PILOT PLANT
Pilot Plant facility is used for scale up and development of our new products and processes as well as commercial manufacture to support our customer's smaller volume requirements.
The facility consists of 6 Fully Flexible reactors , available in both glass lined and Stainless Steel. The array of reactors gives a capacity from 50 liters upto 150 litere. The reactors are complemented by a range of enclosed filter dryer's for solids handling with fractional and short path distillation equipment for liquids. The Pilot Plant is connected to the site ring main system meaning that the vessels are all vented to our Scrubber system.

MICROBIOLOGY LABORATORY

Our Microbiology Laboratory is a well equipped with AHU and all the required equipments like Laminar Flow, POD Incubator, Autoclave, Quality Control, Microscope, pH Meter etc. as per regulatory requirements.

This allows us to carry out all the microbiological the analysis In-House like Total Bacterial count, Total Fungal Count in purified water, Environmental Monitoring GMP areas.