Sourcing Process in Pharmaceucticals

Will be decided based on the

Global Scan for best destinations to source APIs following criteria:-
1. Number of DMF’s/ANDA’s
submitted by a country in the
Master Database of API Manufacturers past and to be submitted in
future until 2015.
…………………… 2. Political/Risk and Trade
Italy India China Spain
security with the USA.
3. History of IP
violation/infringements.
4. cGMP/GMP compliance;
List of Qualified suppliers *
5. EHS compliance and good
Italy India China …………………… Spain corporate citizenship;
6. Patent strategy;
*Indicates suppliers who manufacture APIs required by client,
Who also have FDA approvals, active DMFs, CGMP/GMP compliant 7. Product quality;
and comply with 8. Quality specifications and
Minimum acceptable standard (ICH Q7A) analytical methods
9. DMF review management;
10. Supply chain;
Run RFQs to find the best price quote
11. API supply chain evaluation;
12. Launch management;
1. Develop Input cost models/cost of production in short listed countries.
2. Compare with Price quotes from API suppliers to find the profit margin 13. Cost competitiveness;
14. API cost drivers in the
country;

Contract Maintenance : short-term/long term/market based pricing or Flexi price 15. Strategies for maintaining
cost competitiveness and
ANDA – Abbreviated New Drug Application
DMF – Drug Master Files 16. Multiple source qualification
strategy
Quality Audits at regular intervals during contract period IP _ Intellectual Property
GMP – Good Manufacturing Practice
Follow up with Customs clearance & shipping
cGMP – current Good Manufacturing Practice
EHS - Environmental Health & Safety