FORMULATION DRUGS - GOA
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Pharma Technology Development Center |
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Plant View |
GOA - This small tropical paradise lies on the west coast of India. It is well connected with the rest of the world through International Airport, seaport as well as through railways, highways and best of communication network.
The Goa plant is exclusively dedicated to the manufacturing of non-antibiotic oral solid dosage forms.
Goa plant consistently meets cGMP guidelines and WHO specifications. Environmental regulations and safety requirements are also rigorously complied with.
In the manufacturing area, all the processing rooms have their own dedicated air handling system to prevent cross contamination. Each processing area has total environmental control and a record of temperature, humidity and pressure gradient is maintained and monitored through a sophisticated computer program. It has an ultra-filtered recirculating loop purified water system meeting International Standards.
The highly automated PLC controlled high speed machines make it possible to take up manufacturing of more sophisticated products with assured Quality Standards. This Plant also supports the International Business Operations and enables the Company to meet the international standards of Good Manufacturing Practices.
- The Goa Plant is approved by Food and Drug Administration (US FDA), Medicines Control Council (MCC) - South Africa, Medicines & Healthcare Products Regulatory Agency (MHRA) - U.K., Therapeutic Goods Administration - Australia, ANVISA-Brazil, WHO (Geneva) and by many other regulatory authorities.
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Pharma Technology Development Centre - Goa
Unichem Goa is not only focusing on World-class infrastructure but is also having its forays in Research and Development capabilities. The Pharma Technology Development Centre (PTDC) at Goa is now fully functional.
The focus is on development of generic formulations comprising Immediate Release as well as Novel Drug Delivery Systems and ANDAs exclusively for US market. The facility has been equipped to handle the development of formulation for New Chemical Entities (NCE’s)
The PTDC facility has a team of highly result oriented scientists to lead the research efforts and is a self-contained State-of-the-Art product development laboratory meeting cGMP requirements which is fully equipped to conduct pre-formulation studies, prototypes development, scale-up & optimization and technology transfer of oral solid dosage forms. The team also developed expertise in handling New Chemical Entities.
Each cubicle in the core process area is constructed with clean room partition made of stainless steel. The core process area has a dedicated Air Handling Unit with pressure balancing arrangement to avoid cross contamination.
The developmental activities are supported by highly talented Analytical Research Development team which is equipped with sophisticated instruments for carrying out analytical method development such as assay methods, dissolution methods, discriminating methods, stability indicating methods and stability testing.
The PTDC has capability of developing a platform technology whereby different molecules shall be processed for their controlled rate of release.
For the PTDC, technology transfer is simple, smooth and effective as it is located in the same premises of manufacturing facility and the procedures followed are in line with cGMP and simulating each condition of manufacturing.
Modern techniques, trained professionals, hi-tech minds, the perfect set-up and the right environment are the essentials to maintain a world class infrastructure, which is exactly what lies at Unichem-Goa.
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