Pharmaceuticals Inc, USA, (GPI), the wholly owned subsidiary
of Indian pharmaceutical company Glenmark Pharmaceuticals
Ltd, has signed a new supply and marketing agreement with
Lehigh Valley Technologies, Inc (LVT) to manufacture and
market seven products for the US market.
products, with a cumulative market size of $2.8 billion,
belong to the controlled substances category which have
limited competition. These products, which are for pain
management are a mix of immediately release and controlled
release solid oral dosage formulations.
to the agreement, LVT will develop and manufacture the
products, which will be filed with the FDA under the Glenmark''s
name and marketed exclusively by the Glenmark in the US
new deal, according to Glenn Saldanha, managing director
and CEO, " greatly enhances our product basket and
takes us closet to establishing our presence as a Company
selling niche products in the highly competitive US generics
market. Presently, we are marketing 10 products in the
US and expect to meet our target of ending the year with
18 to 22 generics in the market."
currently markets codeine sulphate and morphine sulphate,
from its deal with Aspen USA, Inc, signed earlier this
year. Glenmark also says that it is in the process of
launching three more controlled substance products before
the end of FY07of which one is from Aspen and the other
two from LVT, which it had in-licensed earlier this year.
One of the products, Oxycodone HCI capsules is due to
be launched next week.
LVT collaboration is in line with our strategy of developing
our product portfolio with products having greater margins
and sustainability," explained Terrance Coughlin,
president of Glenmark''s US subsidiary. "We have already
captured significant inroads into this niche market with
the launch of the two Aspen products since August 2006,"
has filed a total of 35 ANDAs as of October 2006 from
its US FDA approved facility at Goa. It had purchased
two ANDAs from Clonmel Healthcare Ltd in FY 2005. In addition
to filing ANDAs, Glenmark''s efforts to accelerate its
portfolio build-up have involved in-licensing generics
from US based manufacturers, collaboration agreements
for joint development with other Companies and also acquisition
strategic co-development tie-ups with Shasun Chemicals
and Drugs Ltd and InvaGen Pharmaceuticals Inc. together
account for 20 additional filings, to which Glenmark has
had launched its sales and marketing front-end in the
January 2005 and has 10 generics on market as of October
2006. The Company also has 25 ANDAs undergoing the US
FDA approval process.