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Q. What is the advantage of a grass-root built cGMP facility?
Facility built from the grass-root level is designed in best possible manner to compliment the cGMP requirements. Unlike the GMP modified units these units will not have to be renovated, changed or reconstructed for any GMP developments. This assures quality and unrestricted workflow.

Q . Why European cGMP consultants?
In India GMPs had been given a statutory status as late as 1988. India doesn't have a team/company/group working as professional GMP consultants with much experience. The European consultants help Vedants to build a facility as per the stringent norms of European cGMP.

Q . What is the Indian Contract manufacturing organizations scenario?
The cGMP built plants in India are either producing commercial products or catering to their own requirements. CMOs present in India are few who are built as per EU cGMP. There are more rectified cGMP units than a grass-root level cGMP built CMO. Vedants is a pioneer by hiring European consultants for cGMP & building a dedicated CMO from grass-root level.

Q . What is the World Contract manufactruing organizations scenario.
Overcapacity due to paucity of new drugs & unexpected failure of high profile drugs & increasing competition from low cost Asian competitors. Cost of a new cGMP plant in the west is about 15-20 times more expensive than in Asia. The annual costs for maintaining & running an GMP plant is also very high.

 
 

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