Morepen Labs today announced a Joint Venture with Drugmax
Inc. of Florida for marketing of it’s generic offerings
in USA. Drugmax is a NASDAQ listed (DMAX) $300 million
pharmaceutical distribution company, which caters to pharmacy
chains, retailers, wholesalers etc. all over USA. Headquartered
in Florida, Drugmax has offices in Ohio, Pennsylvania,
Louisiana etc. and is armed with over 20,000 SKUs from
leading pharmaceutical manufacturers and has the license
to ship to over 50 states. The Joint Venture with Drugmax
will give Morepen’s products a direct entry into
the US markets and will provide them immediate shelf space
in the competitive Generic Drugs scenario prevailing in
USA.
Under the Joint Venture, Morepen will form an SPV (Special
Purpose Vehicle) with Drugmax in which Morepen will hold
the majority stake. As per the agreement, the new entity
will be the marketing arm for the USA generic operations
and Morepen will undertake the manufacturing of all the
products in India as per the USFDA Guidelines. Another
role of this SPV will be to complete all regulatory approvals
and to file ANDA (Abbreviated New Drug Application) on
behalf of Morepen, for an entire range of generic products,
beginning with Loratadine . Drugmax will provide the necessary
support and know how for filing for the ANDA, which is
required for generics in finished dosage format under
the US regulatory system. To cater to this market, formulation
manufacturing facilities are being set up by Morepen,
in accordance with the USFDA guidelines. India offers
a low cost advantage of supplying high quality generic
drugs at competitive price.
Commenting on the Joint Venture, Mr.Sushil Suri,
CMD, Morepen Labs said, "This Joint Venture
is a milestone for us and will lay the foundation for
a strong presence for Morepen in the USA markets. With
a number of generic drugs worth an estimated US $83 billion
scheduled to go off patent by the year 2005 it provides
us with immense business opportunity. Morepen Labs is
moving up the value chain and this marketing tie-up will
act as a bridge between the Morepen products and the US
market place further strengthening our bottom line."
Morepen is the largest producer of Loratadine - non-sedative
anti-allergic drug besides the innovator Schering Plough
of USA. Morepen got the USFDA approval for manufacturing
Loratadine in March 1999 and has an exclusive tie-up with
Geneva Pharmaceutical of USA, which is first generic company
to file ANDA in USA for Loratadine and has six months
exclusive marketing rights post patent expiry in the year
2002. Morepen also have strategic understanding with over
10 generic companies in USA and Canada for supply of Loratadine
in the near future. Loratadine which is one of the largest
selling drug in the world, enjoys over 50% market share
among all anti-histamines and the market size of Loratadine
is currently estimated at over 3.2 Billion US$ with USA
being the major Loratadine market – with over 85
per cent. This new tie-up will put Morepen into an advantageous
position and will open new vistas of growth for Morepen
in the US Generic Market thereby contributing substantially
to the future growth.
By successfully compiling with USFDA standards for Loratadine
, Morepen has cleared the decks for other generic product
entries in the world market. While catering to a growing
list of customers across regulatory markets in the US,
Canada, Europe etc., Morepen has introduced new products
like Fexofenadine, Atorvastatin and Zafirlukast in the
global market. In the R&D pipeline are products like
Pioglitazone, Montelukast, Levofloxacin, Fluvastatin and
Gatifloxacin. The standards prescribed by USFDA are extremely
stringent and the toughest quality checks to meet in the
world. Any facility that has received this seal of approval;
is held in high esteem, and hence Morepen products find
easy acceptance in the highly regulated world markets.
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Morepen Laboratories Limited (MLL) is a preferred generic
manufacturer of bulk drugs internationally and the largest
generic manufacturer of Loratadine in the world. With
a market capitalization of more than US$ 200 million and
three high-tech plants at Himachal, MLL exports to over
50 countries, including the highly regulated markets of
USA, Western Europe and Canada. A leadership position
in its core business of bulk drugs, adherence to international
quality standards with USFDA approved facilities and a
strong R&D base gives Morepen the cutting edge required
to meet the demands of an economy poised to enter the
GATT regime. Besides bulk drugs, Morepen is a professionally
managed, R&D based company that is also engaged in
manufacturing and marketing of Formulation dosage forms.
Morepen has made a foray into the self-health category
with Dr.Morepen- its FMHG brand.
