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.