|
The Company's Formulations Research Group is focused on developing niche, complex, difficult-to-make finished products, with the target of creating a differentiated product pipeline. The research focus is on first-to-file opportunities, niche filings and filings in differentiated therapies. These barriers to entry ensure higher sales and profitability and a sustainable position for the Company.
With as many as 28 Abbreviated New Drug Applications (ANDAs) filed with the USFDA, FY 2008-09 was a milestone year for Lupin's Formulations research group. The cumulative number of ANDA filings now stands at 90, with 34 approvals granted by the USFDA. Furthermore, the cumulative first-to-file opportunities now stand at 8. FY 2008-09 also marked the foray of the Company into the niche area of Oral Contraceptives (OC) and 7 OC ANDAs were filed during the course of the year. The Company had 5 first-to-files of which 2 are potentially exclusive first to files for the Generic versions of Fortamet ER® (Metformin extended release tablets) and Antara® (Fenofibrate tablets).
| |
|
|
 |
|
|
|
click the image
to zoom |
|
|
The year has not only raised the standard of expectations from the Formulations Research Group but has also set the bar for the industry in terms of the quality of filings, be it controlled release, exclusive and unique first-to-files or well thought out niche filings. The Company remains geared to maintain this momentum in times to come.
ANDAs:
|
Country |
Filed |
Approved |
|
US: |
98 |
35 |
|
Europe: |
|
|
|
UK |
22 |
9 |
|
France |
13 |
8 |
|
New Zealand |
5 |
5 |
|
Australia |
21 |
16 |
|
Others |
19 |
6 |
GENERICS - PROCESS RESEARCH
Lupin has always striven to be a benchmark in developing cost-effective and reliable APIs. The Company's process research capabilities have helped build a robust backward integrated model for complex and difficult-to-develop APIs. Well-versed with the stringent norms governing process chemistry for the synthesis of API, the Company is focused on developing cost-effective, non-infringing and eco-friendly technologies. It has conscientiously deployed various emergent tools such as biocatalysis, metal-mediated chemistry and use of water as reaction media as far
as possible, in addition to novel separation techniques.
In FY 2008-09, Lupin extended its scope of activities to initiate research in the niche area of steroidal hormones. For this, the Company has already invested in state-of-the-art infrastructure for both, research and manufacturing, with adherence to stringent safety and operational norm & standards.
| |
|
|
 |
|
|
|
click the image
to zoom |
|
|
During FY 2008-09, the Company filed 11 USDMF filings and 6 EDMFs/COSs.
DMFs:
|
Country |
Approved |
|
US |
90 |
|
EU |
95 |
|
Australia/NZ |
17 |
|
Korean |
5 |
|
ROW: |
|
|
South East Asia |
131 |
|
CIS |
129 |
|
Middle East & North Africa |
29 |
|
Africa |
128 |
|
South Africa |
7 |
|
Latin & Central America |
78 |
|
WHO/GDF |
5 |
| 
