c


„
 


  

 







 

 

 c




 


c  

 !
"     

 #
$ " c%
 $

& %'"(  )* $

  !''
) &

+ ,



 -

- 
%    .

.  
"  /

/ 0
'
) !! 

  

 1c%
 

 
2  "  $$


cc3  

INTRODUCTION
The Indian Pharmaceutical Industry has come a long way from being almost
non-existent in the 1970¶s tobeing one of the largest and most advanced
Pharmaceutical industries in the world. The domesticPharmaceutical output has
increased at a CAGR of 13.4.Currently the Indian Pharmaceutical Industry
isvalued at $ 8 billion (approx).Globally the industry ranks 4 th in terms of
volume and 13th in terms of value. Itprovides employment to millions and
ensures that essential drugs are available to the vast population ofIndia at
affordable prices. Indian Pharmaceutical Industry has attained wide ranging
capabilities in thecomplex field of drug manufacture and technology developed
through a range of governmental incentivesand the industry has been declared a
knowledge based industry. This Industry is a highly organized sectorand is
extremely fragmented with severe price competitions and governmental price
control. The majorplayers in the Industry are Ranbaxy, Dr. Reddy¶s
Laboratories, Cipla, Sun Pharmaceutical Industries, LupinLab, Glaxo
SmithKline Pharmaceutical, Cadila Healthcare, Aventis etc.

,c415
India has the highest number of manufacturing plants approved by US FDA,
which is next only to that inthe US. More than 85% of the formulations
produced in the country are sold in the domestic market. Over60% of India's
bulk drug production is exported. In dia holds the lion's share of the world's
contract researchbusiness as activity in the Pharmaceutical market continues to
explode, over 15 prominent contract researchorganizations (CROs) are now
operating in India attracted by her ability to offer efficien t R&D on a low-cost
basis. Thirty five per cent of business is in the field of new drug discovery and
the rest 65 per cent ofbusiness is in the clinical trials arena. India offers a huge
cost advantage in the clinical trials domaincompared to Western count ries. India
got a major boost with the signing of Trade Related Intellectual


0
'
  
 6''
)7

Established in the year 1990, with Research & Development as its prime
fundamental, Divis Laboratories focussed on developing new processes for t he
production of Active Pharma Ingredients (APIs) & Intermediates. The company
in a matter of short time expanded its breadth of operations to provide complete
turnkey solutions to the domestic Indian pharmaceutical industry. With five
years of experience, expertise and a proven track-record of helping many
companies with its turn-key and consulting strengths, Divis Laboratories
established its first manufacturing facility in 1995.Built on a 500 acre site at
Hyderabad (Unit-I). the plant comprises of 13 multi-purpose production blocks
and has space for further growth and expansion.

Divis Laboratories set up its second manufacturing facility at Visakhapatnam

(Unit-II). in the year 2002 on a 350 acre site. The site has 14 multi purpose
production blocks. Both the facilities are primarily engaged in the manufacture
of:

y? Active Pharmaceutical Ingredients (APIs) & Intermediates for Generics

y? Custom Synthesis of API's and Advanced intermediates for discovery
compounds for pharma giants
y? Building blocks for Peptides
y? Building blocks for Nucleotides
y? Carotenoids
y? Chiral ligands

Complete cGMP guidelines are compli ed with in both the plants. Unit-1 at
Hyderabad was successfully inspected by the US FDA during September 2000,
in April 2004 and in February 2008. Our Unit -2 at Visakhapatnam was
successfully inspected by the US FDA during November 2006. Divis also
undertakes FTE/Contract Research on process development for discovering new
compounds for leading MNCs across the world and partners with them for the
supply of APIs. The company is global in its outlook and benchmarks its quality
standards to the best in the world. 

c,

 8"% 

To maintain leadership in custom synthesis of APIs and Intermediates for health
care and life sciences industry and to be one of the top companies world -wide in
the domain. To develop generic APIs for the late life cycle needs of the
Industry.


c

  ' 
To be a good corporate citizen and not only add value in our core competency
areas of Pharma but also serve the community at large through social,
educational and environmental initiatives that would establish strong
foundations for a better tomorrow.


?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?
?

?

1990 : Divis Research Center (DRC) established.

1991-1993 : DRC successfully develops several commercial processes for
intermediates and bulk actives and supplies to
manufacturing majors.
1994 : Divis Research Center changes its name to Divis
Laboratories Limited to reflect its growing area of
operations and its plans to enter the manufacturing sector
in the following year.
1995 : Manufacturing Facility (Unit-1) at Choutuppal near
Hyderabad starts operations.
1997 : SGS-Yarsley of U.K certifies Divis Laboratories as ISO-9002
compliant.
1999 : European Directorate gives a �Certificate of
Suitability� (CoS) for Naproxen produced at Divis
Laboratories.
2000 : US-FDA inspects Divis Laboratories successfully SGS-
Yarsley of U.K awards Divis the ISO 9001 Certification SGS
International AG of Switzerland awards Divis the ISO-14001
Certification (for its efficient Environment Management
Systems).
2001 : BVQI of London awards Divis the OHSAS-18001
Certification (for its Occupational Health and Safety
Management Systems).
2002 : Divis commences the setting up of its 2nd Manufacturing
Facility (Unit-2) at Chippada near Visakhapatnam.
2003 : Divis opens a new research center christened �DRC-
Vizag� for fundamental research in selected niche
business core segments.
2003 : Went for IPO and listed on stock exchanges BSE, NSE and
HSE.
2004 : US-FDA inspects the Choutuppal (Unit-1) for a second time.
No 483.
2006 : US-FDA inspects the Visakhapatnam(Unit-2) for the first
time.
2008 : Third US-FDA inspection for Choutuppal(Unit-1).
2008 : KFDA inspects the Visakhapatnam(Unit-2) for the first time.
 2009 : KFDA inspects the Visakhapatnam(Unit-2) for the second
time.
2009 : US-FDA inspects the Visakhapatnam(Unit-2) for the second
time.


 
" 9
4
" 

Divis manufacture API's for the Generics. As a company Divis understand that
sustained development is not possible without respecting IPR. Divis takes great
care to ensure that its products or processes do not infringe valid patents.Divis is
actively involved in developing alternate, patent non -infringing processes for
APIs, for the inventors to manage late life cycle and leading generic drug
manufacturers.


 

Divis supplies advanced intermediates for generic APIs that are already out of
patent, as also for APIs which are about to enter generic status shortly. Here
again, Divis has tie-ups with both original inventors and generic API
manufacturers.

 "c
 c"
 

Divis has built up a strong base in the manufacture of BOC, FMOC and CBZ
protected amino acids, the protecting reagents themselves, peptide condensing
agents, totally synthetic, natural and novel unnatural amino -acids and
oligopeptides. Divis has invested heavily in knowledge, equipment and man -
power to expand in this technology area which is sophisticated, challenging and
of course rewarding. Currently, Divis is a major manufacturer of protected
amino-acids.

*
% *

Divis has an established and proven expertise in stereo selective synthesis using
chiral ligands, high yield resolutions using chirally active resolving agents,
recovery of resolving agents and ligands, recycling of undesirable isomers,
resolutions involving enzymes and manuf acture of novel ligands like binol,
binap and so on.

 
 6 *
"7

"

"% 

Divis has succeeded in developing multistep total synthesis of important

carotenoids like Apocarotenal, Betacarotene, Lycopene, Astaxanthin,
Canthaxanthin etc.

)!! 


 0
'
%  
 


The company is visualising several new opportunities for further investments as

the global economic situation improving, the company is very firm in deploying
their investments in the areas where we have expertise.

Some targets like anti-cancers, steroids, prostaglandins etc., are generally

considered toxic but in small doses they are useful medicines because of their
high potency. These are also of high value. Manufacture of such high potency
APIs requires special facilities and training of scientists to overcome hazards to
the persons and environment. There are also few manufacturers in this niche
area both in India and abroad, who have built capabilities for manufacture of
High Potency APIs. It is reported that by 2012, the high-potency drug market
alone will reach 80 billion dollars worldwide. Annual growth rate of 8.4% is
predicted upto 2015 by Newport forecasts.

Divi¶s has already made a beginning by dev eloping a process and dedicated
facility for manufacturing a highly potent prostaglandin analogue used in
glaucoma. We also have a process and facility ready for manufacture of a
highly potent anti-cancer drug. The facilities include sophisticated and
dedicated laboratory, pilot plant and manufacturing areas and specially trained
chemists and engineers.


1

1cc3  9
* 9
y? Large pool ofà D personnel 
y? Strong financials 
y? 14000 skilled workforces 
y? Largest distribution networks-2500+skilled field force. 
y? Increasing liberalization of government policies. 
y? Efficient technologies for large number of generic drugs. 
y? Strong brand image. 
12 9
y? Lack of experience to exploit efficiently the new patent regime. 
y? Stricter registration procedures. 
y? Alternatives are easily available. 
y? Low or NO switching over costs for the customers. 
y? Severe competition. 
y? Inadequate funds. 
y? Lack of inadequate infrastructure. 
!! 


 9

y ? Growing income 

y ? Growing attention to health. 

 y ? Globalization. 

y ? New therapy approaches. 

y ? New diagnoses and new social diseases. 

y ? Saturation point of the market is far away. 

y ? Ageing of the world organization. 


* 9

y ? High entry costs in new markets 

y ? High costs of sales and marketing. 

y ? High costs of discovering new products, Few discoveries


2  " 
Divi lays emphasis on risk management and has an enterprise -wide approach to
risk management, which lays emphasis on identifying and managing key
operational and strategic risks. Through this approach, the company strives
to identify opportunities that enhance organisational values while managing or
mitigating risks that can adversely impact its future performance. The risk
management framework entails regular review of risk status and risk exposure
by designated senior management committees. Divi is engaged in manufacture
of generic APIs, custom synthesis of active ingredients for innovator companies
and other specialty chemicals like peptides and nutraceuticals. From the very
inception of manufacturing operations, the company committed itself to
respecting intellectual property and playing a complementary role to its
innovator customers thus ensuring a consistent business in custom synthesis.
The company constantly reviews its policies and procedures to adhere to
conformity to the various regulatory approvals for its manufacturing facilities,
its commitment to IPR. With a diverse product portfolio, the company has a
unique derisked business model. The company has a review mechanism to
monitor foreign exchange and various ot her business risks and take appropriate
measures. The company¶s current and fixed assets are adequately insured
against various risks. The company¶s risk management and control procedures
involve prioritization and assessment of the risks and devise appropriate
controls, evaluating and reviewing the control mechanism and redesigning it
from time to time in the light of its effectiveness.