Full Press Release Details
| Dr. Reddy's Laboratories Ltd. | |
| 8-2-337, Road No. 3, Banjara Hills, | |
| Hyderabad - 500 034, Telangana, | |
| India. | |
| CIN: L85195TG1984PLC004507 | |
| Tel : +91 40 4900 2900 | |
| Fax : +91 40 4900 2999 | |
| Email : mail@drreddys.com | |
| www.drreddys.com |
| Corporate Relationship Department | National Stock Exchange of India Ltd. | ||
| BSE Limited | "Exchange Plaza" | ||
| Dalal Street, Fort | Bandra-Kurla Complex, Bandra (East), | ||
| Mumbai - 400 001 | Mumbai - 400 051 | ||
| Fax Nos.: | 022-22723121 / 22723719 / 22722037/ 22722039 | Fax Nos.: | 022-26598120/ 26598237/ 26598238 |
| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Please find enclosed a Press Release on
"Dr. Reddy's Laboratories announces the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules in
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| DR. REDDY'S LABORATORIES LTD. | CONTACT | |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | Investor relationS | Media relationS |
| AMIT AGARWAL amita@drreddys.com (Ph: +91-40-49002135) | MITALI SARKAR mitali.sarkar@drreddys.com (Ph: +91-40- 49002121) |
Reddy's Laboratories announces the launch of
Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules in the U.S. Market
Hyderabad, India and Princeton, NJ, USA. June 22, 2019-
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as
"Dr. Reddy's") today announced the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules,
a therapeutic equivalent generic version of Vitamin K1 (Phytonadione) Injectable Emulsion USP, 10 mg/ml, approved by the U.S. Food
and Drug Administration (USFDA).
"We're pleased to bring this product to market for
the customers and patients who will benefit from access to this medicine and who have in the past experienced supply disruptions
in the market place," explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy's Laboratories.
"This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio to drive
growth for the Global Hospitals segment."
The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10
mg/ml brand and generic had combined U.S. sales of approximately $46.6 million MAT for the most recent twelve months ending in
April 2019 according to IQVIA Health*.
Dr. Reddy's Phytonadione Injectable Emulsion USP, 10 mg/ml
Single-Dose Ampules is available in 1 mL Ampule containing 10 mg/mL of Phytonadione.
WARNING: INTRAVENOUS
AND INTRAMUSCULAR USE
Severe reactions, including fatalities, have occurred during
and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and
to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration.
Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory
arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time.
Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be
restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
About Dr. Reddy's: Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable
and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients,
Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs,
custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets
across the globe. Our major markets include - USA, India, Russia & CIS countries, and Europe. For more information,
log on to: www.drreddys.com
Disclaimer: This press release may include
statements of future expectations and other forward-looking statements that are based on the management's current views
and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to
differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason
of context, the words "may", "will", "should", "expects", "plans", "intends",
"anticipates", "believes", "estimates", "predicts", "potential", or "continue"
and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from
those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets,
credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events
(ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes
in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization
, including related integration issues.
The company assumes no obligation to update any information contained herein.