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For Indian pharmaceutical companies,
there are very few options to explore in the product patent
era. Being unable to invest the kind of funds needed for
''discovery research'' they are finding in contract manufacturing
the means to maintain high growth rates.
Their expertise
in process research and development (mainly reverse engineering)
will prove handy. They want to leverage this strength
to grow bigger by transforming their relationship from
one of vendors to global producers to that of strategic
partners in the next millennium.
Ranbaxy Laboratories and Lupin Laboratories
were among the first Indian companies to bag manufacturing contracts from multinational
companies -- Ranbaxy from Eli Lilly and Lupin from Cynamid.
When Ranbaxy developed an alternative process for
manufacturing Eli Lilly''s patented drug Cefaclor, the American company sensed that it
would lose its markets to Ranbaxy''s low-cost substitute in countries that did not
recognise product patents. To make the best of a bad situation, Eli Lilly offered a
manufacturing contract to Ranbaxy for producing 7 ACCA (intermediate for cefaclor).
In case of Lupin, Cynamid offered contract to the Indian
company for manufacturing D2 amino butanol.
With liberalisation relaxing licensing rules, in the last
few years, Indian companies have found it easy to seek manufacturing partnerships. But,
again, only companies that have modern manufacturing facilities, with sizeable capacities
and financial muscle have been successful in roping in international clients.
The most aggressive Indian company in this direction is Nicholas
Piramal. It made a small beginning through the acquisition of Hoffman La Roche''s
Indian business. Along with the Thane unit of Roche, the Indian company also acquired the
technology for manufacturing vitamin A from the basic stage, with a proviso that it would
not export the product to any other country. With Glaxo''s exit from the vitamin A
business, Nicholas enjoys the monopoly in vitamin A.
In 1997, Nicholas Piramal entered a 49:51 joint venture
with Allergan Inc, USA. Along with marketing rights for Allergan''s products, it also
secured manufacturing rights.
In the same year, it signed a three-way agreement with La
Porte of the UK and another global player from the US for manufacturing inorganic
chemicals. Nicholas Piramal provided the land adjoining Sumitra Pharmaceuticals for
setting up a new plant for the joint venture. To focus on manufacturing, the company spun
off its bulk drugs business into a separate company -- Global Bulk Drugs & Fine
Chemicals -- with effect from 1 April 1998.
In early 1999, Nicholas Piramal signed an agreement with
Siegfried of Switzerland for development and manufacturing of four products that go
off-patent by 2001. Negotiations with the UK-based Baker Norton are at the final stage for
a local joint venture. Here, again, Nicholas Piramal will offer the local manufacturing
option for the entire range of Norton''s products.
On the bulk drug front, the company is holding talks with
several international companies to lease unutilised capacities at its Hyderabad unit, one
among them being Apotex of Canada.
For Wockhardt India Ltd too, contract manufacturing
is a serious consideration. This Rs 600-crore pharmaceutical company has recently built a
Rs 40-crore manufacturing facility in Chandigarh to make nutritional products. This unit
will be the main plant for contract manufacturing.
Wockhardt recently signed an agreement with Ferring BV of
the Netherlands for manufacturing certain formulations for export to the Scandinavian
countries. The products will be made at Wallis Laboratories, a UK-based company acquired
by Wockhardt for $5 million. The bulk drug for the formulations will be sourced from
India.
Recently Wockhardt signed a memorandum of understanding
with US-based Sidmak Laboratories for marketing generic formulations in America. Sidmak
will formulate the products, and Wockhardt will supply the bulk drug inputs for them.
Similarly, for the Mumbai-based Kopran group,
originally a producer of bulk drugs, which later ventured into formulations, contract
manufacturing is a decisive strategy in the tough new era of product patents that India is
moving into.
To add focus to its multi-pronged approach, the group has
formally de-merged into three separate companies. The formulation and bulk drug business,
other than penicillin-G, has been retained by Kopran Ltd, the flagship company. The
penicillin-G business was spun off into Kopran Drugs Ltd and research into Kopran Research
Laboratories Ltd. The company recently signed an MOU with Synpac Laboratories for the
supply of penicillin-G bulk.
Cadila Healthcare, of the Ahmedabad-based Zydus
Group, is yet another Indian-controlled pharma group that has entered contract
manufacturing. It has tied up with Byk Gulden of the Netherlands for supplying the Dutch
company''s global bulk drug requirement of the anti-ulcerant molecule pentaprazole.
Says Dilip Sanghvi, managing director, Sun
Pharmaceuticals, "Our philosophy is to seek an opportunity where we can add
value. Rather than go in for vendor-type contract manufacturing, we would prefer to
partner an international manufacturer. That will give us the chance to contribute and
learn. For instance, taking country-specific rights, product development and dossier
preparation. This moves us up the learning curve for developed markets."
With an eye on the burgeoning generics market in the US,
Sun Pharma acquired a 45 per cent stake in the US-based Caraco Pharmaceuticals. The Indian
company has transferred technologies for 21 products to the American company so far.
Sun
Pharma will supply bulk drugs for all the products for
which Caraco has received US FDA approval for its abbreviated
new drug applications. The ANDA approvals are a mandatory
requirement for marketing generic drugs in the US. Caraco,
in turn, will formulate the brands for marketing in the
United States.
Not to be left behind, Dr Reddy''s Laboratories has
commissioned a Rs-60 crore formulation unit in Hyderabad, dedicated solely to contract
manufacturing.
also see : Report on
contract manufacturing
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