API, active pharmaceutical ingredient is key spend line item for pharmaceutical companies. In order to have strategic alliance with right vendor, one should evaluate API manufacturing experience that each vendor carries. Best way to check API mfg strength of potential strategic vendors is by evaluating their US DMF count. Below is the list of top 10 US DMF holders in Type II category.
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
|Company||US DMF Count|
|TEVA or TAPI||311 ( website says 370 APIs )|
|MSN||266 ( website says 152 APIs )|
|AUROBINDO PHARMA||215 (SEC filings states 220 APIs)|
|MYLAN||213 ( website says 250 APIs )|
|DR REDDY||205 ( website says 450 + globally)|
As expected, market was led by TAPI which holds close to 311 DMFs under Type II DMF category, followed by MSN, Aurobindo, Mylan & Dr Reddy.
Below are some important points from analysis:
- Total of 10243 active DMF count were recorded in Type II DMF category.
- Top 12 players accounted for ~23% of overall DMF count, with more than quarter of this 23% coming from Teva and MSN alone.
- Only 5 companies accounted for greater than 2% of DMF count share, and included likes of Dr Reddy, Aurobindo Pharma, Mylan and two mentioned in above point.
DMF count might appear as just another number but it is one of the most important KPI to understand vendor’s technical know-how. Hence, the above mentioned vendors if part of your incumbent list, should be retained as is, and must be transitioned to strategic vendors going forward. If otherwise, these suppliers must be positioned in your preferred partner list, probably for future consignments mapped to large volumes.
Source 1 : http://www.msnlabs.com/api-dmfs.html
Source 2 : http://www.aurobindo.com/docs/press-room/press-reports/aurobindo-pharma-ltd-q4-fy-16-17-and-fy-1617-press-release.pdf
Source 3 : https://www.tapi.com/ProductCatalog.pdf?v=812