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FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
of the Securities Exchange Act of 1934
For the Month of June 2011
Commission File Number — 1-15182
DR. REDDY’S LABORATORIES LIMITED
(Name of Registrant)
7-1-27, Ameerpet
Hyderabad, Andhra Pradesh 500 016, India
+91-40-23731946
Hyderabad, Andhra Pradesh 500 016, India
+91-40-23731946
(Address of Principal Executive Offices)
Indicate by check mark whether registrant files or will file annual reports under cover of Form
20-F or Form 40-F.
Form 20-F þ Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted
solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted
to furnish a report or other document that the registrant foreign private issuer must furnish and
make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled
or legally organized (the registrant’s “home country”), or under the rules of the home country
exchange on which the registrant’s securities are traded, as long as the report or other document
is not a press release, is not required to be and has not been distributed to the registrant’s
security holders, and, if discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant
is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes o No þ
If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule
12g3-2(b):
Not applicable.
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Press Release
|
 |
|
| Dr. Reddy’s Laboratories Ltd. | ||
| 8-2-337, Road No. 3 | ||
| Banjara Hills, Hyderabad — 500 034 | ||
| Andhra Pradesh, India | ||
| Tel: 91-40-4900-2900 | ||
| Fax: 91-40-4900-2999 | ||
| www.drreddys.com |
Dr. Reddy’s announces three generic product launches in the US Market
Hyderabad, India, June 6, 2011 — Dr. Reddy’s Laboratories (NYSE: RDY) today announced that it has
launched the following three products in the US market:
| • | Donepezil Hydrochloride tablets (5mg and 10mg strengths), a bioequivalent generic version
of ARICEPT® tablets*. The Food & Drug Administration (FDA) approved Dr. Reddy’s ANDA for
Donepezil HCl tablets on May 31, 2011. Both strengths of Dr. Reddy’s Donepezil Hydrochloride
tablets are available in 30, 90 and 500 count bottles. |
| • | Venlafaxine Hydrochloride Extended Release capsules (37.5mg, 75mg and 150mg strengths), a
bioequivalent generic version of EFFEXOR XR® Extended Release capsules**. The Food & Drug
Administration (FDA) approved Dr. Reddy’s ANDA for Venlafaxine Hydrochloride Extended Release
Capsules on May 05, 2011. All three strengths of Dr. Reddy’s Venlafaxine Hydrochloride
Extended Release Capsules are available in 30, 90 and 500 count bottles. |
| • | Letrozole tablets, USP (2.5mg), a bioequivalent generic version of FEMARA®***. The Food &
Drug Administration (FDA) approved Dr. Reddy’s ANDA for Letrozole tablets, USP on June 3,
2011. Dr. Reddy’s Letrozole tablets, USP are available in 30 count bottles. |
Notes to the editor:
| • | The ARICEPT® brand and Donepezil Hydrochloride tablets generic had total combined U.S.
sales of approximately $2.3 billion for the twelve months ending March 31, 2011 according to
IMS Health. |
| • | The EFFEXOR XR® brand and Venlafaxine Extended Release Capsules generic had total combined
U.S. sales of approximately $2.3billion for the twelve months ending March 31, 2011 according
to IMS Health. |
| • | The FEMARA® brand had U.S. sales of approximately $702 Million for the twelve months ending
March 31, 2011 according to IMS Health. |
IMS National Sales Perspectives: Retail and Non-Retail MAT 03/31/2011
| * | ARICEPT®, is a registered Trademark of Eisai R&D Management Co. Ltd. |
|
| ** | EFFEXOR XR®, is a registered Trademark of Wyeth, LLC |
|
| *** | FEMARA®, is a registered Trademark of Novartis Corporation |
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of venlafaxine hydrochloride extended-release
capsules or any other antidepressant in a child, adolescent, or young adult
must balance this risk with the clinical need. Short-term studies did not show
an increase in the risk of suicidality with antidepressants compared to placebo
in adults beyond age 24; there was a reduction in risk with antidepressants
compared to placebo in adults aged 65 and older. Depression and certain other
psychiatric disorders are themselves associated with increases in the risk of
suicide. Patients of all ages who are started on antidepressant therapy should
be monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should be
advised of the need for close observation and communication with the
prescriber. Venlafaxine hydrochloride extended-release capsules are not
approved for use in pediatric patients. (See Warnings: Clinical Worsening and
Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric
Use)
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Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities
Litigation Reform Act of 1995. We have based these forward-looking statements on our current
expectations and projections about future events. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to differ materially. Such factors
include, but are not limited to, changes in local and global economic conditions, our ability to
successfully implement our strategy, the market acceptance of and demand for our products, our
growth and expansion, technological change and our exposure to market risks. By their nature, these
expectations and projections are only estimates and could be materially different from actual
results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. Through its three businesses
— Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products — Dr.
Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services,
generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and
pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa,
Romania, and New Zealand. For more information, log on to: www.drreddys.com
CONTACT INFORMATION
Investors and Financial Analysts:
Kedar Upadhye at kedaru@drreddys.com / +91-40-66834297
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Milan Kalawadia (North America) at mkalawadia@drreddys.com / +1-908-203-4931
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Milan Kalawadia (North America) at mkalawadia@drreddys.com / +1-908-203-4931
Media:
Rajan
S at rajans@drreddys.com / +91-40- 49002445
4
Table of Contents
Press Release
|
|
|
| Dr. Reddy’s Laboratories Ltd. | ||
| 8-2-337, Road No. 3 | ||
| Banjara Hills, Hyderabad — 500 034 | ||
| Andhra Pradesh, India | ||
| Tel: 91-40-4900-2900 | ||
| Fax: 91-40-4900-2999 | ||
| www.drreddys.com |
Dr. Reddy’s Chemical Manufacturing Facility at Cuernavaca, Mexico Receives Warning Letter from
USFDA
Hyderabad, India, June 14, 2011:
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) announced today that Industrias Quimicas Falcon de Mexico
SA de C.V. (Dr. Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned
subsidiary of Dr. Reddy’s Laboratories Limited has received a four item Warning Letter from the
United States Food and Drug Administration (USFDA).
The USFDA inspected Dr. Reddy’s Mexico facility in November 2010. That Inspection resulted in
issuance of Form FDA 483, with observations. Dr. Reddy’s felt it responded to the 483 observations
by implementing a number of corrective actions. However, the USFDA has asked for additional data
and corrective actions to the items listed in the Warning Letter. Dr. Reddy’s takes these matters
seriously and will respond to the USFDA within the stipulated timeframe. Dr. Reddy’s looks forward
to working collaboratively with the USFDA to resolve the matters contained in the Warning Letter.
The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients.
Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities
Litigation Reform Act of 1995. We have based these forward-looking statements on our current
expectations and projections about future events. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to differ materially. Such factors
include, but are not limited to, changes in local and global economic conditions, our ability to
successfully implement our strategy, the market acceptance of and demand for our products, our
growth and expansion, technological change and our exposure to market risks. By their nature, these
expectations and projections are only estimates and could be materially different from actual
results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. Through its three businesses
— Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products — Dr.
Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services,
generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and
pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa,
Romania, and New Zealand. For more information, log on to: www.drreddys.com
CONTACT INFORMATION
Investors and Financial Analysts:
Kedar Upadhye at kedaru@drreddys.com / +91-40-66834297
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Milan Kalawadia (North America) at mkalawadia@drreddys.com / +1-908-203-4931
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Milan Kalawadia (North America) at mkalawadia@drreddys.com / +1-908-203-4931
Media:
Rajan
S at rajans@drreddys.com / +91-40- 49002445
5
Table of Contents
Press Release
|
|
|
| Dr. Reddy’s Laboratories Ltd. | ||
| 8-2-337, Road No. 3 | ||
| Banjara Hills, Hyderabad — 500 034 | ||
| Andhra Pradesh, India | ||
| Tel: 91-40-4900-2900 | ||
| Fax: 91-40-4900-2999 | ||
| www.drreddys.com |
Dr. Reddy’s announces the launch of Levofloxacin tablets
Hyderabad, India, June 22, 2011:
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Levofloxacin tablets
(250 mg, 500 mg and 750 mg), a bioequivalent generic version of LEVAQUIN®* tablets in
the US market on June 20, 2011, following the approval by the United States Food & Drug
Administration (USFDA) of Dr. Reddy’s ANDA for Levofloxacin tablets.
The LEVAQUIN® brand had U.S. sales of approximately $1.1 billion for the most recent
twelve months ending March 2011 according to IMS Health.
Dr. Reddy’s Levofloxacin tablets 250 mg and 500 mg strengths are available in 50 count bottles and
the 750 mg strength is available in 30 count bottles.
Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities
Litigation Reform Act of 1995. We have based these forward-looking statements on our current
expectations and projections about future events. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to differ materially. Such factors
include, but are not limited to, changes in local and global economic conditions, our ability to
successfully implement our strategy, the market acceptance of and demand for our products, our
growth and expansion, technological change and our exposure to market risks. By their nature, these
expectations and projections are only estimates and could be materially different from actual
results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. Through its three businesses
— Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products — Dr.
Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services,
generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and
pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa,
Romania, and New Zealand. For more information, log on to: www.drreddys.com
| * | LEVAQUIN®, is a registered trademark of Daiichi Sankyo Company, Limited. |
IMS National Sales Perspectives: Retail and Non-Retail MAT March 2011
CONTACT INFORMATION
Investors and Financial Analysts:
Kedar
Upadhye at kedaru@drreddys.com / +91-40-66834297
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Raghavender R at raghavenderr@drreddys.com / +91-40-49002135
Milan Kalawadia (North America) at mkalawadia@drreddys.com / +1-908-203-4931
Media:
Rajan
S at rajans@drreddys.com / +91-40- 49002445
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| DR. REDDY’S LABORATORIES LIMITED | ||||||||
| (Registrant) | ||||||||
| By: | /s/ Sandeep Poddar | |||||||
Date: July 5, 2011
|
Name: | Sandeep Poddar | ||||||
| Title: | Company Secretary | |||||||
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