Dr Reddys Laboratories Ltd 6-K, filed Feb 27, 2020
Dr Reddys Laboratories Ltd (RDY)
About this 6-K
Dr Reddys Laboratories Ltd filed this 6-K on February 27, 2020.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
February, 2020
Commission File Number 1-15182
DR. REDDY’S LABORATORIES LIMITED
(Translation of registrant’s name into English)
8-2-337, Road No. 3, Banjara Hills
Hyderabad, Telangana 500 034, India
+91-40-49002900
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
| Form 20-F x | Form 40-F ¨ |
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): ______
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): ______
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 ¨ | No x |
If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.
EXHIBITS
SIGNATURES
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) | |||
| Date: February 27, 2020 | By: | /s/ Sandeep Poddar | |
| Name: | Sandeep Poddar | ||
| Title: | Company Secretary | ||
Exhibit 99.1
 |
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 |
February 27, 2020
| 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 / | Fax Nos.: 022-26598120/ 26598237/ | |
| 22722037 / 22722039 | 26598238 |
| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Dear Sirs,
Sub: Intimation
This is to inform you that the audit of our Integrated Product Development Organization (IPDO) at Medchal-Malkajgiri, Telangana, by the US FDA, has been completed today, and no Form 483 was issued at the closure of the audit.
This is for your information.
With regards,
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
Exhibit 99.2
| |
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 |
February 27, 2020
| 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 / | Fax Nos.: 022-26598120/ 26598237/ | |
| 22722037 / 22722039 | 26598238 | |
| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on “Dr. Reddy's Laboratories announces the first generic launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets in the U.S. Market”
This is for your information.
With regards,
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
Encl: As above
CC: New York Stock Exchange (Stock Code: RDY)
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. |
AMIT AGARWAL amita@drreddys.com
(Ph: +91-40-49002135) |
Deep GHATAK deepghatak@drreddys.com (Ph: +91-40- 49002121) |
Dr. Reddy's Laboratories announces the first generic launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets in the U.S. Market
| Hyderabad, India, February 27, 2020 | For Immediae Release |
Hyderabad, India and Princeton, NJ, USA. February 27, 2020 — 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 first-to-market launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, a therapeutic equivalent generic version of Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets approved by the U.S. Food and Drug Administration (USFDA).
“This launch is a testament to our core strengths in areas of research and development and intellectual property,” says Marc Kikuchi, Chief Executive Officer, North America Generics. “We are excited to be a part of forming the first generic market for Vimovo® Tablets and to provide an affordable treatment alternative for patients.”
The Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets brand had U.S. sales of approximately $414 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health*.
Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of 60.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
| · | Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. |
| · | Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. |
Gastrointestinal Bleeding, Ulceration, and Perforation
| · | NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. |
Please see the full prescribing information including boxed warning as well as medicatin guide.
https://www.drreddys.com/pi/naproxen-eso-leaflet.pdf
https://www.drreddys.com/pi/naproxen-eso-mg.pdf
Vimovo® is a trademark of Horizon PharmaMedicines LLC.
*IQVIA Retail and Non-Retail MAT December 2019.
RDY-1019-264
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.