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<keyword id="20555600" type="General" weightage="20" keywordseo="Dr-Reddys-Laboratories" source="keywords" meta.keywordsubtype="org" meta.entityname="Dr Reddy's Laboratories" meta.hostid="261" meta.entityid="Dr Reddy's Laboratories">Dr Reddy's Laboratories</keyword> and <keyword id="20026907" type="General" weightage="20" keywordseo="Sun-Pharma" source="keywords" meta.keywordsubtype="org" meta.entityname="Sun Pharma" meta.hostid="261" meta.entityid="Sun Pharma">Sun Pharma</keyword> are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (<keyword id="19914245" type="General" weightage="20" keywordseo="USFDA" source="keywords">USFDA</keyword>). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the US market due to the "presence of foreign substance". The company initiated the Class II nationwide (US) recall on June 7, 2024, the US health regulator said. The USFDA said a US-based unit of Sun Pharma is recalling 2,088 vials of Decitabine for Injection (50mg per vial) due to "CGMP Deviations". The affected lot of the chemotherapy medication was produced at Sun Pharma's Gujarat-based manufacturing plant. New Jersey-based Sun Pharmaceutical Industries Inc. initiated the nationwide Class II recall on July 2 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. SEE ALSO:<a href="https://www.businessinsider.in/sports/webstories/virat-kohli-not-included-in-the-rohit-sharma-led-icc-team-of-the-tournament/slidelist/111398470.cms" target="_blank"></a> <a href="https://www.businessinsider.in/sports/webstories/virat-kohli-not-included-in-the-rohit-sharma-led-icc-team-of-the-tournament/slidelist/111398470.cms" target="_blank">Virat Kohli not included in the Rohit Sharma-led ICC Team of the Tournament</a><a href="https://www.businessinsider.in/business/auto/news/upcoming-cars-launching-in-india-in-july-2024/slidelist/111341281.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/auto/news/upcoming-cars-launching-in-india-in-july-2024/slidelist/111341281.cms" target="_blank">Upcoming cars launching in India in July 2024</a><a href="https://www.businessinsider.in/business/telecom/news/reliance-jio-and-airtel-price-hike-new-plans-and-how-you-can-save-money/articleshow/111331794.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/telecom/news/reliance-jio-and-airtel-price-hike-new-plans-and-how-you-can-save-money/articleshow/111331794.cms" target="_blank">Reliance Jio and Airtel price hike – new plans and how you can save money</a>

Dr Reddy's, Sun Pharma recall drugs in US market: USFDA

<ul><li>The portfolio includes approximately 45 commercial products, four pipeline products and 40 approved non-marketed products, including a number of generic products focused on women's health.</li><li><keyword id="44587" type="General" weightage="20" keywordseo="Dr-Reddy" source="Orion">Dr Reddy</keyword>'s will acquire the portfolio for an upfront payment of approximately $90 million in cash.</li><li>For the financial period ended June 30, 2022, <keyword id="277934" type="General" weightage="20" keywordseo="Mayne-Pharma" source="Orion">Mayne Pharma</keyword> reported total revenue of $111 million for the acquired portfolio.</li></ul> <keyword id="67944" type="General" weightage="20" keywordseo="Dr-Reddys-laboratories" source="Orion">Dr Reddy's Laboratories</keyword> Ltd on Monday said its subsidiary entered into a definitive agreement to acquire the US generic prescription product portfolio of Australia-based Mayne Pharma Group Limited for USD 105 million. A press release form Dr Reddy's said the portfolio includes approximately 45 commercial products, four pipeline products and 40 approved non-marketed products, including a number of generic products focused on women's health. Under the terms of the agreement, Dr Reddy's will acquire the portfolio for an upfront payment of approximately USD 90 million in cash, contingent payments of up to USD 15 million, consideration towards inventory and credits for certain accrued channel liabilities to be determined on the closing date, it said. For the financial period ended June 30, 2022, Mayne Pharma reported total revenue of USD 111 million (USD) for the acquired portfolio. Approved high-value products include a hormonal vaginal ring, a birth control pill and a cardiovascular product. The closing of the transaction is subject to satisfactory completion of customary closing conditions including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended. The acquisition will complement Dr Reddy's US retail prescription <keyword id="6469017" type="General" weightage="20" keywordseo="pharmaceutical" source="Orion">pharmaceutical</keyword> business with limited competition products. It also supports Dr Reddy's efforts to accelerate and expand affordable medications for patients, the release further said. Marc Kikuchi, Chief Executive Officer, North America business, Dr Reddy's, said, "This important acquisition provides our North America organisation with a significant foothold in the women's health space. The acquisition is in line with our stated strategy to enhance our portfolio in our chosen growth markets. We are well-positioned to successfully integrate the portfolio and grow the business." Erez Israeli, Chief Executive Officer, Dr Reddy's, said, "The portfolio of products acquired from Mayne Pharma is a strategic fit with our growth objectives. The portfolio includes some high entry-barrier products. It also complements our existing portfolio by introducing products focused on women's health. Our strong balance sheet enables us to acquire products of strategic importance to strengthen our base business and build for long-term growth." The value of total addressable market for the pipeline and approved non-marketed products in the US is approximately USD 3.6 billion for the calendar year ending in December 2022 according to IQVIA, the release said.

Dr Reddy's acquires Mayne Pharma's USA prescription portfolio for $105 Mn

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Dr Reddy's, Sun Pharma recall drugs in US market: USFDA

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Dr Reddy's acquires Mayne Pharma's USA prescription portfolio for $105 Mn

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