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Sun Pharmaceuticals Industries Ltd News

Dr Reddy's, Sun Pharma recall drugs in US due to production issues: USFDA

Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). 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

Dr Reddy's, Sun Pharma recall drugs in US due to production issues: USFDA
Updated On : 04 Jul 2024 | 6:08 PM IST

USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility

Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, as per the US Food and Drug Administration (USFDA). In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said. The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated. USFDA further noted that the company's investigations

USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
Updated On : 04 Jul 2024 | 6:48 AM IST

ITC, NTPC, LIC Housing among 10 F&O stocks to watch ahead of June expiry

The Nifty PCR data suggests that the index may attempt a rally towards 23,700 level ahead of the June series expiry; On the downside, strong support is expected around 23,350 - 23,290.

ITC, NTPC, LIC Housing among 10 F&O stocks to watch ahead of June expiry
Updated On : 25 Jun 2024 | 10:17 AM IST

Sun Pharma completes Taro merger, acquires all outstanding shares

New York headquartered Taro has operations in the US, Canada, Israel, and Japan with manufacturing facilities in Canada (Brampton) and Israel (Haifa)

Sun Pharma completes Taro merger, acquires all outstanding shares
Updated On : 24 Jun 2024 | 5:46 PM IST

Sun Pharma inks MoU with Takeda to introduce gastrointestinal drug in India

Sun Pharmaceutical Industries on Friday said it has inked a licensing pact with Takeda Pharmaceutical Company to commercialise a novel gastrointestinal drug in India. The company has entered into a non-exclusive patent licensing agreement with Takeda to commercialise Vonoprazan tablets in strengths of 10 and 20 mg in India, the Mumbai-based drug major said in a statement. Vonoprazan is a novel, orally active potassium competitive acid blocker (PCAB), used to treat reflux esophagitis and other acid peptic disorders. "Sun Pharma is a leader in gastroenterology and we are excited to introduce Vonoprazan in India under non-exclusive patent license from Takeda," Sun Pharma CEO - India Business Kirti Ganorkar said. The partnership demonstrates the company's commitment to gastrointestinal health by providing patients and healthcare practitioners with a novel treatment option to manage reflux esophagitis and other acid peptic disorders, he added. Gastroesophageal Reflux Disease (GERD) is

Sun Pharma inks MoU with Takeda to introduce gastrointestinal drug in India
Updated On : 21 Jun 2024 | 10:54 AM IST

USFDA issues warning letter to Sun Pharma's Dadra unit; stock slips 2%

The fall came after the company announced that it has received a warning letter from USFDA for current Good Manufacturing Practice (cGMP) violations at its Dadra facility

USFDA issues warning letter to Sun Pharma's Dadra unit; stock slips 2%
Updated On : 20 Jun 2024 | 11:09 AM IST

Sun Pharma expects high single-digit top line growth in current fiscal: MD

Drug major Sun Pharmaceutical Industries expects a high single-digit top line growth in the current fiscal, according to Managing Director Dilip Shanghvi. The Mumbai-based firm reported a consolidated total revenue from operations at Rs 48,497 crore for FY24. The number stood at Rs 43,886 crore in FY23. "We expect high single-digit consolidated top line growth for FY25. All our businesses are positioned for growth," Shanghvi said in an analyst call. He noted that in the current fiscal, the drug firm will be in the investment phase for its several businesses. "This includes, but not limited to, product launch costs in the US as the ramp-up of our global specialty business is expected to continue," Shanghvi said. He noted that R&D investments will be 8-10 per cent of sales during the year. Replying to a separate query, Shanghvi said: "We have to continue to invest for the future. And our effort would be that while we are creating that investment for future, we don't do it at the ..

Sun Pharma expects high single-digit top line growth in current fiscal: MD
Updated On : 02 Jun 2024 | 11:16 AM IST

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA
Updated On : 30 May 2024 | 7:44 PM IST

US-based firm Taro's shareholders approve merger with Sun Pharmaceutical

The merger agreement between Sun Pharma and Taro was approved by an affirmative vote of Taro shareholders at an extraordinary general meeting and an ordinary class meeting on May 22

US-based firm Taro's shareholders approve merger with Sun Pharmaceutical
Updated On : 23 May 2024 | 8:09 PM IST

Weak Q4 due to lower growth may be rare bitter pill for Sun Pharma

Sun Pharma is in the process of acquiring US-based Taro Pharmaceuticals and taking it private

Weak Q4 due to lower growth may be rare bitter pill for Sun Pharma
Updated On : 23 May 2024 | 10:21 PM IST

Sun Pharma hits over 3 month low; slips 5% in strong market post Q4 results

The management guided for high single digit revenue growth in FY25 factoring in the impact of US site compliance issues.

Sun Pharma hits over 3 month low; slips 5% in strong market post Q4 results
Updated On : 23 May 2024 | 1:21 PM IST

Sun Pharma Q4 result: Profit up 33% over strong US, specialty sales

Firm guides for high single-digit top line, higher R&D spend in FY25; board approves appointment of Dilip Shanghvi as chairman

Sun Pharma Q4 result: Profit up 33% over strong US, specialty sales
Updated On : 22 May 2024 | 7:24 PM IST

Sun Pharma Q4 results: Net profit rises 34% to Rs 2,655 cr, revenue up 10%

Sun Pharma Q4FY24 results: The board of the company recommended a final dividend of Rs 5 per equity share of Re. 1 for the financial year 2023-24

Sun Pharma Q4 results: Net profit rises 34% to Rs 2,655 cr, revenue up 10%
Updated On : 22 May 2024 | 3:37 PM IST

Q4 Results Today: Sun Pharma, Grasim, Nykaa Among 32 Firms to Post Earnings

Company Results Q4 FY24: Jubilant, Ramco Cements, NIIT Learning also anticipated to release fourth quarter earnings on May 22

Q4 Results Today: Sun Pharma, Grasim, Nykaa Among 32 Firms to Post Earnings
Updated On : 22 May 2024 | 11:06 AM IST

Sun Pharma Q4 Preview: Profits may grow up to 41% on higher specialty sales

Sun Pharma is set to see a strong financial earnings on a year-on-year (Y-o-Y) basis for Q4FY23, showing a 8-14 per cent Y-o-Y jump in its topline

Sun Pharma Q4 Preview: Profits may grow up to 41% on higher specialty sales
Updated On : 21 May 2024 | 2:59 PM IST

Sun Pharma gets Rs 1.11 cr tax demand over disallowed input tax credit

Sun Pharmaceutical Industries Ltd on Monday said it has received a tax demand of over Rs 1.11 crore from authorities over disallowed input tax credit. The company has received an order from the Joint Commissioner, CGST and Central Excise, passed under the GST Act, raising a demand of Rs 1,11,60,156, imposing a penalty of Rs 11,16,016 and interest as applicable, Sun Pharmaceutical Industries said in a regulatory filing. The reason for the order is disallowed input tax credit on account of inadmissible transitional credit, it added. "There is no material impact on financial, operation or other activities of the company," the filing said.

Sun Pharma gets Rs 1.11 cr tax demand over disallowed input tax credit
Updated On : 29 Apr 2024 | 9:38 PM IST

Investment idea: Motilal Oswal bullish on Sun Pharma; check outlook, upside

Sun Pharma, the brokerage said, is building an interesting specialty pipeline (under development) for addressing patient's needs in areas of dermatology, ophthalmology, and onco-dermatology

Investment idea: Motilal Oswal bullish on Sun Pharma; check outlook, upside
Updated On : 24 Apr 2024 | 11:50 AM IST

Sun Pharma slips 3% after OAI status from USFDA for Dadra facility

In an exchange filing Sun Pharma said, the US Food and Drug Administration (US FDA) conducted an inspection at the company's Dadra facility from December 4, 2023 to December 15, 2023

Sun Pharma slips 3% after OAI status from USFDA for Dadra facility
Updated On : 12 Apr 2024 | 9:58 AM IST

Sun Pharma gets approval to sell acne treatment cream Winlevi in Australia

Collaboration with Cosmo enables rights for cream in several countries, says company

Sun Pharma gets approval to sell acne treatment cream Winlevi in Australia
Updated On : 19 Mar 2024 | 1:14 PM IST

Sun Pharma gets regulatory nod in Australia for acne treatment cream

Sun Pharmaceutical Industries Ltd on Tuesday said the Australian Therapeutic Goods Administration has granted regulatory approval for Winlevi cream indicated for the topical treatment of acne. The approval is for Winlevi (clascoterone cream 1 per cent), which is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, the company said in a statement. Sun Pharma received the exclusive right to develop and commercialise Winlevi in the US, Japan, Australia, New Zealand, Brazil, Mexico, and Russia from Cosmo, it added. "Winlevi is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia. Winlevi's novel mechanism of action will be a welcome addition to the physician's toolkit while treating acne," Hellen de Kloet, Business Head, Western Europe, Australia and New Zealand, Sun Pharma, said. The company said Winlevi will be available in Australia this June. "This is another achievement in the mission of Cosmo and

Sun Pharma gets regulatory nod in Australia for acne treatment cream
Updated On : 19 Mar 2024 | 10:46 AM IST