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operationBackground
R-Cinex Anti-TB 1
AKT Anti-TB 1
Akurit Anti-TB 1
R-CIN Anti-TB 1
G-CIN Gemifloxacin 1
Combutol Ethambutol& 1
Comb.
Pyzina Pyrazinamide 2
Plain
Market 52-Week
Sales(Rs.Million Current Change
Company P/E Ratio Cap. High/Low
) Price (%)
(Rs.Million)
Glaxosmithkline
18707.67 2038.00 -0.30 32.03 173149.91 2271/1086
Phar
Lupin 28985.60 1815.60 0.12 24.87 161393.89 1844/755
AstrazenecaPharm
3965.06 841.00 1.41 39.15 20732.50 1109/570
a
Fresenius
2620.83 129.05 3.16 53.38 19794.28 163/42
KabiOncol
Suven Life
1400.11 28.35 3.09 45.78 3204.75 37/18
Sciences
Piramal Life
21.30 130.50 4.99 0.00 3163.60 152/50
Science
12800/251
Zandu Realty 877.46 3540.00 -0.65 8.66 2873.40
3
Sharon Bio-
4197.91 115.00 2.68 5.30 1182.37 144/42
Medicine
Bharat
71.08 18.75 3.02 0.00 785.88 26/17
Immunological
Rubra
10.21 61.85 4.92 0.00 322.36 59/10
Medicaments
Syncom
575.64 26.50 4.33 6.47 315.22 34/15
Formulations
Maxter
Merotrol Meropenem 1
Tazar Piperacillin + 1
Tazobactam
Ceff Cephalexin Oral 3
Solids
Cetil Cefuroxime Oral 5
Solids
Cefantral CefotaximeInjectible 9
s
Escitalopram 10mg +
Stalopam Plus Antidepressant
Clonazepam 0.5mg
Citicoline 500mg
Nootropic
(250mg/ml)
Citicoline 1000 mg
Sustained Release Nootropic
tablets
Levetiracetam 250mg
Epilive Antiepileptics
Tablets
Levetiracetam 500mg
Antiepileptics
Tablets
Levetiracetam 750mg
Antiepileptics
Tablets
Oxcarbazepine 300mg
Lovax OD Antiepileptics
Extended Release
Oxcarbazepine 600mg
Antiepileptics
Extended Release
Pregabalin 75mg +
Pregadoc M Mecobalamin 750mcg Agent for Neuropathic Pain
Capsules
Pregabalin 150mg +
Mecobalamin 750mcg Agent for Neuropathic Pain
Pinnacle
For more details on the below given information, kindly
visit www.epinnacleworld.com
Atorvastatin + Fenofibrate
TRITONACT Cholesterol Reducer
+ Ezetimibe
Torsemide +
RETORLIX SP Diuretic
Spironolactone
LUPIDIP 2.5/5/10
Amlodipine Anti-Hypertensive
mg
LUPIBOSE
Bosentan Pulmonary Anti-Hypertensive
62.5/125 mg
Endeavour
Brand Name Molecule Therapy Segment
CALCIUM CARBONATE +
CALUFT CAPS CALCITRIOL + ZINC + ANTI-OSTEOPOROSIS
MAGNESIUM + BORON
CALCIUM CITRATE
MALEATE + VIT.D3 + ZINC +
CALUFT-G CALCIUM PREPARATION
MANGANESE + MAGNESIUM
+ COPPER
CEFAXONE 100
CEFTRIAXONE IM/IV ANTI INFECTIVE INJECTABLE
0 Mg
CEFAXONE 125
CEFTRIAXONE IM/IV ANTI INFECTIVE INJECTABLE
Mg
CEFAXONE 250
CEFTRIAXONE IM/IV ANTI INFECTIVE INJECTABLE
Mg
CEFAXONE 500
CEFTRIAXONE IM/IV ANTI INFECTIVE INJECTABLE
Mg
Anti-bacterial
CEFFOREN CEFDITOREN
(CEPHALOSPORIN ORAL)
CO-Q-DENT CO-Q-10 HERBAL TOOTHPASTE
CO-Q-DENT CO-Q-10 HERBAL TOOTHPASTE
PHENYLPROPANOLAMINE
CZ-3 COLD 25MG + CETIRIZINE 5MG + COLD PREPARATION
PARACETAMOL 500MG
CZ-3 SYRUP CETRIZINE ANTI-HISTAMINE
CZ-3 TABLET CETRIZINE ANTI-HISTAMINE
CETRIZINE 5MG +
CZ-COLD PSEUDOEPHEDRINE COLD PREPARATION
30MG/5ML
AMBROXOL 15MG + R-
SALBUTAMOL 1MG +
CZ-EX COUGH PREPARATION
GUAIPHENESIN 50 MG +
MENTHOL 0.5MG
DEXTROMETHORPHAN +
CETRIZINE +
CZ-TUS COUGH PREPARATION
PSEUDOEPHEDRINE +
MENTHOL
Anti-bacterial
DOXCEF 100 CEFPODOXIME
Lupin Diabetes Care
Brand Name Molecule Therapy segment
Metformin 500 mg
Gluconorm SR Diabetes Management
extended release
Gluconorm SR Metformin 1 gm extended
Diabetes Management
1g release
Metformin 500 mg ER +
Gluconorm G1 Diabetes Management
Glimepiride 1 mg
Metformin 500 mg ER +
Gluconorm G2 Diabetes Management
Glimepiride 2 mg
Metformin 500 mg ER +
Gluconorm P15 Diabetes Management
Pioglitazone 15 mg
Metformin 500 mg ER +
Gluconorm P30 Diabetes Management
Pioglitazone 30mg
Metformin 500 mg ER +
Gluconorm PG-
Pioglitazone 15 mg + Diabetes Management
1
Glimepiride 1 mg
Metformin 500 mg ER +
Gluconorm PG-
Pioglitazone 15 mg + Diabetes Management
2
Glimepiride 2 mg
Gluconorm G1 Metformin 1 gm ER +
Diabetes Management
Forte Glimepiride 1mg
Gluconorm G2- Metformin 1 gm ER +
Diabetes Management
1 Forte Glimepiride 2 mg
Glutide CR Gliclazide Controlled
Diabetes Management
30MG Release 30 mg
Glutide CR Gliclazide Controlled
Diabetes Management
60MG Release 60 mg
Glador 1 Glimepiride 1 mg Diabetes Management
Glador 2 Glimepiride 2 mg Diabetes Management
Glador 3 Glimepiride 3 mg Diabetes Management
Glador 4 Glimepiride 4 mg Diabetes Management
Lipril 2.5 Lisinopril 2.5 mg Diabetic Hypertension
Lipril 5 Lisinopril 5 mg Diabetic Hypertension
Lipril 10 Lisinopril 10 mg Diabetic Hypertension
Lisinopril 5 mg +
Lipril AM Diabetic Hypertension
Amlodipine 5 mg
Lisinopril 5 mg +
MARKET SHARE OF LUPIN PHRMA
Financials:
Advanced markets – US & Europe
Lupin continued its growth momentum in the US and Europe
a healthy contribution of 36% to our total revenues at Rs.
13634 million. (Formulations)
USA:
Lupin Pharmaceuticals Inc., the company’s US subsidiary,
reported a stellar performance recording sales of Rs. 12563
million reflecting a growth of 74.4% as compared to Rs. 7205
million in FY 07-08. Lupin’s Generic and Branded business
recorded exponential growth during the financial year.
More importantly, FY 08-09 saw Lupin increasing its product
portfolio in the branded generics segment through the
launch of AeroChamber Plus®. LPI forged a Strategic
Alliance with Forest Laboratories, Inc. for marketing and
promoting AeroChamber Plus® thereby extending Lupin’s
presence in the respiratory segment and our franchise with
Pediatricians which would also additionally open up new
offices for Suprax. The brand business contributed 27% to
the overall business at USD 74 mn
The company further expanded and consolidated on its
generic product portfolio with the launches of Ramipril caps,
Divalproex DR tabs, Cefadroxil suspension and caps
&Levetiracetam tabs. The Company now has a total of 22
products in the market, out of which 8 are market leaders.
We are in the top 3 market positions by market share in 17 of
these products (IMS Jan 09).
Lupin today is one of the fastest growing generic players in
the US based on growth in prescriptions and the 9th largest
in terms of total prescription base.
LPI was also recognized by Wal-Mart and awarded its
prestigious “Supplier Award of Excellence” for the 2nd
Quarter 2008 – which is an acknowledgement of the inroads
we have made into the US markets.
During the year, the company demonstrated its capabilities
on the Intellectual Property management front by
successfully litigating and settling all ongoing Hatch-
Waxman litigation relating to Desloratadine tablets, the
generic version of Schering-Plough’s "Clarinex"® tablets. As
per the terms of the settlement, Lupin Ltd. will be licensed
under the relevant Desloratadine patents, and free to
commercially launch its generic Desloratadine product, on
July 1, 2012, or earlier in certain circumstances. Schering-
Plough’s Clarinex® tablets had U.S. sales of $329 million for
the year 2007-MAT June 2008, according to IMS Health.
Lupin also received the final approval for the Company’s
Abbreviated New Drug Application (ANDA) for Levetiracetam
Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S.
Food and Drug Administration (USFDA). Commercial
shipments of the product have commenced.
Lupin’sLevetiracetam tablets are the AB-rated generic
equivalent of UCB Pharmaceuticals’ Keppra® tablets,
indicated as adjunctive therapy in the treatment of certain
types of seizures associated with epilepsy. Keppra tablets
had annual sales of approximately $ 1.2 billion (USD) for the
twelve months ended September 2008, based on IMS Health
sales data.
Europe:
Lupin further strengthened its presence in the European
Union by completeing its acquisition of HormosanPharma
GmbH (Hormosan), a German generics company specialized
in the supply of pharmaceutical products for the Central
Nervous System (CNS).
We also recorded our first strategic win in the German
market through Hormosan in the next two quarters – having
received information on the results of the
AllgemeineOrtskrankenkassen (AOK) Tender, pursuant to §
130a SGB V. Hormosan has been offered to supply Setraline
in all 5 regions of Germany covering all AOK-insured
persons.
Hormosan has a strong brand identity in the German
generics market through its strong patient compliance
message, essential for patients within the CNS sector.
Lupin also made strategic inroads into the French market by
launching CefpodoximeProxetil suspension in Q3.
CefpodoximeProxetil has over 60 % market share in France.
AAMLA
Japan:
Kyowa, the Company’s subsidiary in Japan posted robust
net sales of Rs. 4424 mn contributing 12% of Lupin’s
Revenues having grown at over 21 % YoY
Our products like Amlodipine “Amel” continues to maintain
majority market share and Risperidone “Amel”, which was
launched last year, continue to exhibit market leadership in
unit terms.
South Africa
Lupin clocked in revenues of Rs 919 million after having
acquired an equity stake in Pharma Dynamics (PD) in South
Africa in September 08. Pharma Dynamics is one of the
fastest growing generic companies in South Africa growing
at around 30 % for FY 08-09 with a clear leadership in the
cardiovascular segment.
PD is ranked number 6 amongst generic companies in South
Africa. The South African Generics Market is currently
valued at close to 800 Million USD and growing rapidly
Phillipines
In March 2009 the Company acquired a majority stake in
MulticarePharmaceuticals Phillipines, Inc. (MC) in
Phillipines. MC is a premium branded generics company
with a strong position in women’s health and child care
segment.
ANZ
The Company continued its focus on this important market
with aggressive filings in Australia, taking the cumulative
MAA filings to 24 till date of which 18 have been approved.
Emerging Markets
India
Domestic Formulations forms a very important part of
Lupin’s overall growth. In the current financial year, it
contributed about 28% of the net sales at Rs 10,575 million
as against Rs. 8,487 million registering a growth of 24.6%
over the previous year.
This growth was driven by the good performance in the CVS,
Diabetes, CNS, Asthma and Gastro therapy Segments. The
divisions catering to branded segments continued to
outpace the industry growing over 27%. Lupin has
maintained its leadership in Anti-TB segment and has
secured a double digit market share in the anti-asthma
market riding high on the strengths of its offering in this
segment.
Research and Development
Research & Development has always been a strategic and
key focus area for Lupin and this year – 2008-09 was no
exception with 6% of the sales earmarked for R&D and
related spends.
The year 2008-09 was a landmark year with Lupin filing 28
Abbreviated New Drug Application (ANDA) with the USFDA,
11 DMFs, 15 MAAs and two EDMFs during the year.
The cumulative ANDA filings stood at 90 with 34 approvals
granted by the USFDA.
Lupin also received the final approval for the Company’s
Abbreviated New Drug Application (ANDA) for Levetiracetam
Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S.
Food and Drug Administration (USFDA) during the quarter.
Other
The USFDA issued a warning letter for the Cephalosporin
facility of the Mandideep plant. The facility was inspected in
November, 2008 for a routine GMP inspection. As a result
Lupin had received 15 procedural observations. Lupin
responded to the observations in December and provided
corrective actions for each of the responses.
The warning letter was issued to provide Lupin with an
opportunity to submit additional documentation and
explanation to a few selected observations where the FDA
felt that the initial responses were inadequate and could be
strengthened by further evidence of compliance with
enhanced documentation practices.
All products maintain their approved status. Lupin
manufacturing will not be disrupted and it will continue to
provide quality products to customers without interruption.
Lupin has formulated a strategy to address and resolve the
USFDA and is confident of being able to satisfy the USFDA’s
observations expeditiously.
Dividend-In view of excellent performance, the Board of
Directors recommended a dividend of 125 % i.eRs. 12.50 per
equity share of the face value of Rs. 10 each.
COMPANY MANUFACTURING/R&D
Business Development
Top of Form
Lupin was founded to meet the very basic need for effective treatment
of tuberculosis. Our success is tied to continually meeting the need
for basic products to promote human health. Our company strives to
bring important new products to market each year. We expect our
products to come from:
• In-house product development;
• Licensing and acquisitions;
• Marketing alliances.
Lupin is also seeking to be the partner of choice for product
development. Our scientists apply know how and expertise to
develop NCE’s or to solve difficult formulation challenges.
We strive for continued growth and are avidly interested in learning
about prospective opportunities in the specialty pharmaceutical
market. We are also open to collaborating to develop innovative
products formulated with Lupin’s drug delivery and taste masking
technology. Our API business unit is seeking partners for Lupin
developed API's.
Please contact us regarding business or product collaboration
opportunities
Phone: 410-576-2000
Facsimile: 410-576-2221
Email: admin@lupinusa.com
NEW Products
Generics
Lupin Pharmaceuticals, Inc. entered the U.S.
generic pharmaceutical market in 2003 with the
ANDA approval for cefuroxime axetil. Since then we
have received more than a dozen FDA approvals.
Six of Lupin's 14 ANDA approvals were the first
granted by the US FDA, reinforcing our ability to
submit high quality dossiers and gain on time
approvals.
We are vertically integrated, from process
development of the API to the submission of
dossiers for finished dosages. This provides
control over the supply chain and the ability to
offer quality products at the right time and at
competitive prices.
Our integrated manufacturing capability provides a
portfolio of the highest quality generic products.
Expanding the product portfolio, Lupin
Pharmaceuticals, Inc. is geared to file 15 or more
ANDA’s per year in some of the following areas:
Oral and injectable cephalosporins;
Cardiovascular;
Controlled release ANDA’s;
Paragraph IV’s.
Our oral and injectable cephalosporin facilities, US
FDA approved manufacturing sites and the new
tablet and capsule facility in Goa, allow us to file
and manufacture a wide range of finished products
for the US market.
Newsroom
Lupin receives FDA approval for Imipramine Pamoate Apr 16, 2010
Capsules
View
Lupin receives FDA tentative approval for Eszopiclone Mar 20, 2010
tablets
View
Lupin receives FDA approval for Perindopril Erbumine Jan 28, 2010
Tablets
View
Lupin receives USFDA approval for Topiramate Tablets May 29, 2008
View
Lupin Receives “Best New Manufacturer of the Year” July 30, 2007
Award from AmerisourceBergen
View
Lupin receives final approval for Amlodipine Tablets July 12, 2007
View
Products
Specialty
A commitment To Caring For Kids
API
Lupin is recognized as a leading manufacturer of
cephalosporin API’s, with FDA approval to manufacture
complex oral and injectable cephalosporins.
Lupin is fast gaining share in the cardiovascular segment
manufacturing a wide range of ACE-inhibitors and
cholesterol reducing agents.
Lupin’s capabilities in sterile processing, synthetic
process development and fermentation skills coupled with
its intellectual property strengths, puts the company in a
very strong position to offer a diverse portfolio of niche
API’s to its customers.
Business Segments
\
in India and a presence in more than 100 countries. [12]In India it the biggest drug maker by
sales[13]
Sales
Yr Market
Turnove
Name Ende Capitalization Net Profit in Rs Cr
r in Rs
d in Rs Cr
Cr
Mar
Lupin 6,473.42 2,661.62 443.38
'08
Mar
Sun Pharma 26,975.87 2,427.35 1,014.04
'08
Mar
Cipla 17,947.66 4,293.95 701.43
'08
GlaxoSmith Dec
9,992.41 1,762.64 576.57
Kline '07
DrReddys Mar
9,662.53 3,428.40 475.22
Labs '08
Market Share on the basis of Retail Sales Due to high level of fragmentation none of the Pharma
Companies had more than 6% of the total market on the basis of the total retail sales.[15]