logo
#

Latest news with #OAI

Stock in focus today: Glenmark Pharmaceuticals shares eyed after US FDA warning letter to Indore facility
Stock in focus today: Glenmark Pharmaceuticals shares eyed after US FDA warning letter to Indore facility

Business Upturn

time2 days ago

  • Business
  • Business Upturn

Stock in focus today: Glenmark Pharmaceuticals shares eyed after US FDA warning letter to Indore facility

Glenmark Pharmaceuticals will be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the United States Food and Drug Administration (US FDA) for its Indore manufacturing facility in Madhya Pradesh. The regulatory action follows an inspection conducted by the US FDA between February 3 and February 14, 2025. In a statement, Glenmark clarified that the warning letter is not expected to impact current supplies or revenues generated from the Indore site. Importantly, the company confirmed that the US FDA's observations did not involve any data integrity issues. 'This warning letter will not affect the availability of our products in the market, and we remain focused on ensuring consistent supply without disruptions,' the company said. Glenmark also reaffirmed its commitment to addressing the concerns raised by the regulator, noting it is working closely with the US FDA to resolve the issues at the earliest possible. The company emphasized its adherence to Current Good Manufacturing Practices (CGMP) and its focus on maintaining high quality and compliance standards across all operations. This development comes after Glenmark had earlier informed on May 9, 2025, that the Indore facility was classified as 'Official Action Indicated' (OAI) by the US FDA. Investors and analysts will closely watch how the stock reacts today as the company works through the regulatory process and reassures the market about its supply chain and compliance measures. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.

Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action
Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action

Time of India

time07-07-2025

  • Business
  • Time of India

Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action

Drug major Sun Pharmaceutical Industries aims to bolster compliance across its manufacturing operations and work towards achieving full regulatory resolution at the three facilities facing USFDA action, according to Chairman and MD Dilip Shanghvi. In his address to shareholders in its annual report for 2024-25, Shanghvi said the company is facing US Food and Drug Administration (USFDA) compliance-related issues at three of its facilities. The company is facing an import alert for the Halol facility and also is in receipt of non-compliance letter for the Mohali facility , he stated. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Shape your journey in the unforgiving desert world of Arrakis! Shop Now Undo Additionally, the company's Dadra facility was accorded an Official Action Indicated (OAI) status in FY24, he noted. "We have completed the implementation of Corrective and Preventive Action (CAPA) in the Halol facility, which is currently awaiting USFDA inspection, and we are in the process of implementing CAPA at the Mohali and Dadra facilities," he added. Live Events Besides these three, all facilities remain compliant with global regulatory standards, including those of the US FDA, Shanghvi said. On the business front, he noted the company expects its R&D investment to be in the range of 6-8 per cent of sales in the current financial year, with enhanced focus on speciality products. The company aims to expand its product pipeline of global speciality products, he added. "Our R&D spend in FY26 is likely to be in the range of 6-8 per cent of sales, with increased spending expected on speciality products," Shanghvi stated. The Mumbai-based drug major invested USD 154 million on speciality products R&D in FY25. Sun Pharma reported consolidated revenues of Rs 52,041 crore in FY25, with the share of global speciality business increasing from 18 per cent in FY24 to 20 per cent in FY25 sales. The company sells speciality products like Ilumya, Winlevi, Cequa and Odomzo across markets. "We anticipate mid to high single-digit consolidated topline growth in FY26, and expect our global speciality business to continue on its growth path," Shanghvi said. Elaborating on the focus areas, he said the company plans to prepare the business for potential disruptions arising from tariffs and geopolitical issues. The company would also continue to focus on cost and operational efficiency, he added.

Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1
Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1

Business Upturn

time11-06-2025

  • Automotive
  • Business Upturn

Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1

By GlobeNewswire Published on June 11, 2025, 21:42 IST MARIETTA, Ga., June 11, 2025 (GLOBE NEWSWIRE) — Yamaha Motor Corp., USA, awarded more than $387,000 in grants through its Yamaha Outdoor Access Initiative (OAI) in the first quarter of 2025, supporting efforts to protect and improve off-highway vehicle (OHV) opportunities across the country, with a particular focus on large-scale projects in Oregon and Georgia. 'Yamaha continues to support a range of projects that address challenges to outdoor recreation, and we're eager to partner with those who share our passion for building and protecting access to the spaces we all enjoy,' said Steve Nessl, Yamaha Motorsports marketing director. 'It's gratifying to see these collaborative efforts evolve into large-scale projects that help make outdoor recreation accessible to everyone.' This quarter's Yamaha OAI grants supported 12 projects, including major investments in OHV riding areas and trail systems in Oregon: The Great Outdoors Fund (supported by Florence Motorsports) was awarded funding for Phase Two of an OHV educational signage project across the Oregon Dunes National Recreation Area, promoting messages of safety, stewardship, regulations, and recreation opportunities. (supported by Florence Motorsports) was awarded funding for Phase Two of an OHV educational signage project across the Oregon Dunes National Recreation Area, promoting messages of safety, stewardship, regulations, and recreation opportunities. The Rogue Valley SxS Club (supported by Waterworld Boat and Powersport) will use its grant to support trail clearing and maintenance on the 270-mile Prospect OHV trail system, with a focus on removing downed trees to keep riders on designated trails. (supported by Waterworld Boat and Powersport) will use its grant to support trail clearing and maintenance on the 270-mile Prospect OHV trail system, with a focus on removing downed trees to keep riders on designated trails. OHV Construction and Conservation (supported by Power Motorsports) will develop a loop trail around the outer edge of the Tillamook State Forest OHV area. The 'Tour of the Tillamook Powered by Yamaha' project encompasses 49 trails, comprising 17 double-track, 13 4×4, and 19 single-track routes, and includes trail development, restoration, maintenance, tree removal, and trail signage. In Georgia, the Georgia Recreational Trail Riders Association (supported by Cycle Specialty) will use its grant to maintain more than six motorized trails and riding areas throughout the state. Work will include bridge repair, culvert installation, and signage. Yamaha OAI grant funds also will protect California's historic Perris Raceway (supported by Langston Motorsports) and continue supporting the All Kids Bike program, which teaches kindergarteners nationwide to ride bicycles as part of their physical education curriculum. Additionally, Yamaha OAI provided grants to the following organizations in Q1 2025: Burbank Police Department Everything Outdoor Fest – D2 Powersports (Spartanburg, SC) Ft. Riley Directorate of Family, Morale, Welfare and Recreation – Brooks Yamaha Inc. (Manhattan, KS) Stewards of the Sierra National Forest Inc – Clawson Motorsports (Fresno, CA) Truckee Dirt Riders – Michael's Reno Powersports (Reno, NV) The Yamaha OAI continues to accept grant applications on a quarterly basis, providing timely resources to address urgent access issues and land rehabilitation efforts. While project types vary, Yamaha OAI prioritizes initiatives that promote safe and responsible OHV use, perform essential trail and land maintenance, and protect, restore, and expand sustainable access to public lands. The application deadline for the second quarter of 2025 is June 30. Yamaha invites public land managers, riding clubs, and stewardship organizations to apply. Submission guidelines and applications are available at Follow Yamaha Outdoors on social media @YamahaOutdoors and tag your adventures with #Yamaha, #YamahaOAI, #REALizeYourAdventure, #ProvenOffRoad, and #AssembledInUSA. About the Yamaha Outdoor Access Initiative Since 2008, the Yamaha Outdoor Access Initiative has led the powersports industry in supporting responsible access to our nation's public lands for outdoor enthusiasts. With more than $6 million contributed to over 470 projects across the country, Yamaha has directly and indirectly supported thousands of miles of motorized recreation trails, maintained and rehabilitated riding and hunting areas, improved staging areas, supplied organizations with essential OHV safety education, built bridges over fish-bearing streams, helped children learn to ride bicycles, and partnered with local outdoor enthusiast communities across the country to improve access to public lands. Each quarter, Yamaha accepts applications from nonprofit or tax-exempt organizations including OHV riding and cycling clubs and associations, national, state and local public land-use agencies, outdoor enthusiast associations, and land conservation groups with an interest in protecting, improving, expanding, and/or maintaining access for safe, responsible, and sustainable public use. For updated guidelines, the application form, and the latest Outdoor Access Initiative news, please visit If you have specific inquiries about the Yamaha Outdoor Access Initiative, you can reach the dedicated hotline at 1-877-OHV-TRAIL (877-648-8724), email [email protected], or send correspondence to: Yamaha Outdoor Access Initiative3065 Chastain Meadows Parkway, Bldg. 100 Marietta, GA 30066 About Yamaha Motor Corporation, USA Yamaha Motor Corp., USA (YMUS), is a recognized leader in the outdoor recreation industry. The company's ever-expanding product offerings include Motorcycles and Scooters, ATV and Side-by-Side vehicles, Snowmobiles, Personal Watercraft, Boats, Outboard Motors, Outdoor Power Equipment, Power Assist Bicycles, Golf Cars [sold, serviced, and distributed by Yamaha Golf-Car Company], Power Assist Wheelchair Systems, Surface Mount Technology and Robotic Machines, Unmanned Helicopters, Accessories, Apparel, Yamalube products, and much more. YMUS products are sold through a nationwide network of distributors and dealers in the United States. YMUS has a corporate office in California, three corporate offices in Georgia, as well as facilities in Wisconsin, Alabama, and Florida. YMUS subsidiaries Yamaha Motor Manufacturing Corporation of America (YMMC), based in Georgia, and Yamaha Jet Boat Manufacturing USA (YJBM) based in Tennessee, each assemble and manufacture selected Yamaha brand products. YMUS owns Skeeter Boats [Texas] with its division G3 Boats [Missouri]. Additional U.S.-based subsidiaries include Yamaha Marine Systems Company, Inc. (YMSC) with subsidiary Siren Marine [Rhode Island] and divisions Bennett Marine [Florida], Yamaha Marine Rotational Molders [Wisconsin] and Yamaha Precision Propeller Inc. [Indiana]. Yamaha Motor Finance Corporation, USA (Yamaha Financial Services), an affiliate of YMUS, offers financing solutions to support Yamaha Dealers and loyal Yamaha Customers nationwide. Yamaha Financial Services provides retail and commercial financing for the diverse line of Yamaha brand motor products based out of Cypress, CA and Marietta, GA. MEDIA CONTACT:Scott NewbyYamaha Motor Corp., USA770-420-6078 [email protected] Photos accompanying this announcement are available at Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.

Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1
Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1

Yahoo

time11-06-2025

  • Automotive
  • Yahoo

Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1

Funding Dedicated to Building and Protecting Motorized Access Across the U.S., With Focus on Oregon and Georgia Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1 Yamaha Outdoor Access Initiative Awards More Than $387,000 in Q1 MARIETTA, Ga., June 11, 2025 (GLOBE NEWSWIRE) -- Yamaha Motor Corp., USA, awarded more than $387,000 in grants through its Yamaha Outdoor Access Initiative (OAI) in the first quarter of 2025, supporting efforts to protect and improve off-highway vehicle (OHV) opportunities across the country, with a particular focus on large-scale projects in Oregon and Georgia. "Yamaha continues to support a range of projects that address challenges to outdoor recreation, and we're eager to partner with those who share our passion for building and protecting access to the spaces we all enjoy," said Steve Nessl, Yamaha Motorsports marketing director. "It's gratifying to see these collaborative efforts evolve into large-scale projects that help make outdoor recreation accessible to everyone." This quarter's Yamaha OAI grants supported 12 projects, including major investments in OHV riding areas and trail systems in Oregon: The Great Outdoors Fund (supported by Florence Motorsports) was awarded funding for Phase Two of an OHV educational signage project across the Oregon Dunes National Recreation Area, promoting messages of safety, stewardship, regulations, and recreation opportunities. The Rogue Valley SxS Club (supported by Waterworld Boat and Powersport) will use its grant to support trail clearing and maintenance on the 270-mile Prospect OHV trail system, with a focus on removing downed trees to keep riders on designated trails. OHV Construction and Conservation (supported by Power Motorsports) will develop a loop trail around the outer edge of the Tillamook State Forest OHV area. The "Tour of the Tillamook Powered by Yamaha" project encompasses 49 trails, comprising 17 double-track, 13 4x4, and 19 single-track routes, and includes trail development, restoration, maintenance, tree removal, and trail signage. In Georgia, the Georgia Recreational Trail Riders Association (supported by Cycle Specialty) will use its grant to maintain more than six motorized trails and riding areas throughout the state. Work will include bridge repair, culvert installation, and signage. Yamaha OAI grant funds also will protect California's historic Perris Raceway (supported by Langston Motorsports) and continue supporting the All Kids Bike program, which teaches kindergarteners nationwide to ride bicycles as part of their physical education curriculum. Additionally, Yamaha OAI provided grants to the following organizations in Q1 2025: Burbank Police Department Everything Outdoor Fest - D2 Powersports (Spartanburg, SC) Ft. Riley Directorate of Family, Morale, Welfare and Recreation - Brooks Yamaha Inc. (Manhattan, KS) Stewards of the Sierra National Forest Inc - Clawson Motorsports (Fresno, CA) Truckee Dirt Riders - Michael's Reno Powersports (Reno, NV) The Yamaha OAI continues to accept grant applications on a quarterly basis, providing timely resources to address urgent access issues and land rehabilitation efforts. While project types vary, Yamaha OAI prioritizes initiatives that promote safe and responsible OHV use, perform essential trail and land maintenance, and protect, restore, and expand sustainable access to public lands. The application deadline for the second quarter of 2025 is June 30. Yamaha invites public land managers, riding clubs, and stewardship organizations to apply. Submission guidelines and applications are available at Follow Yamaha Outdoors on social media @YamahaOutdoors and tag your adventures with #Yamaha, #YamahaOAI, #REALizeYourAdventure, #ProvenOffRoad, and #AssembledInUSA. About the Yamaha Outdoor Access InitiativeSince 2008, the Yamaha Outdoor Access Initiative has led the powersports industry in supporting responsible access to our nation's public lands for outdoor enthusiasts. With more than $6 million contributed to over 470 projects across the country, Yamaha has directly and indirectly supported thousands of miles of motorized recreation trails, maintained and rehabilitated riding and hunting areas, improved staging areas, supplied organizations with essential OHV safety education, built bridges over fish-bearing streams, helped children learn to ride bicycles, and partnered with local outdoor enthusiast communities across the country to improve access to public lands. Each quarter, Yamaha accepts applications from nonprofit or tax-exempt organizations including OHV riding and cycling clubs and associations, national, state and local public land-use agencies, outdoor enthusiast associations, and land conservation groups with an interest in protecting, improving, expanding, and/or maintaining access for safe, responsible, and sustainable public use. For updated guidelines, the application form, and the latest Outdoor Access Initiative news, please visit If you have specific inquiries about the Yamaha Outdoor Access Initiative, you can reach the dedicated hotline at 1-877-OHV-TRAIL (877-648-8724), email OHVAccess@ or send correspondence to: Yamaha Outdoor Access Initiative3065 Chastain Meadows Parkway, Bldg. 100Marietta, GA 30066 About Yamaha Motor Corporation, USAYamaha Motor Corp., USA (YMUS), is a recognized leader in the outdoor recreation industry. The company's ever-expanding product offerings include Motorcycles and Scooters, ATV and Side-by-Side vehicles, Snowmobiles, Personal Watercraft, Boats, Outboard Motors, Outdoor Power Equipment, Power Assist Bicycles, Golf Cars [sold, serviced, and distributed by Yamaha Golf-Car Company], Power Assist Wheelchair Systems, Surface Mount Technology and Robotic Machines, Unmanned Helicopters, Accessories, Apparel, Yamalube products, and much more. YMUS products are sold through a nationwide network of distributors and dealers in the United States. YMUS has a corporate office in California, three corporate offices in Georgia, as well as facilities in Wisconsin, Alabama, and Florida. YMUS subsidiaries Yamaha Motor Manufacturing Corporation of America (YMMC), based in Georgia, and Yamaha Jet Boat Manufacturing USA (YJBM) based in Tennessee, each assemble and manufacture selected Yamaha brand products. YMUS owns Skeeter Boats [Texas] with its division G3 Boats [Missouri]. Additional U.S.-based subsidiaries include Yamaha Marine Systems Company, Inc. (YMSC) with subsidiary Siren Marine [Rhode Island] and divisions Bennett Marine [Florida], Yamaha Marine Rotational Molders [Wisconsin] and Yamaha Precision Propeller Inc. [Indiana]. Yamaha Motor Finance Corporation, USA (Yamaha Financial Services), an affiliate of YMUS, offers financing solutions to support Yamaha Dealers and loyal Yamaha Customers nationwide. Yamaha Financial Services provides retail and commercial financing for the diverse line of Yamaha brand motor products based out of Cypress, CA and Marietta, GA. MEDIA CONTACT:Scott NewbyYamaha Motor Corp., USA770-420-6078Scott_Newby@ Photos accompanying this announcement are available at in to access your portfolio

O-RAN Software Community Advances Open RAN Innovation with J and K Releases, Fostering Better Alignment with Industry Groups and Standards to Further Open RAN Adoption
O-RAN Software Community Advances Open RAN Innovation with J and K Releases, Fostering Better Alignment with Industry Groups and Standards to Further Open RAN Adoption

Globe and Mail

time03-04-2025

  • Business
  • Globe and Mail

O-RAN Software Community Advances Open RAN Innovation with J and K Releases, Fostering Better Alignment with Industry Groups and Standards to Further Open RAN Adoption

New software releases further enable open Radio Access Network (RAN) adoption aligned to O-RAN ALLIANCE standards SAN FRANCISCO and BONN, Germany, April 3, 2025 /CNW/ -- The O-RAN Software Community (O-RAN SC), sponsored by the O-RAN ALLIANCE (O-RAN) and operated by the Linux Foundation, announced the availability of its J and K software releases strengthening collaboration across the open RAN ecosystem. These releases, based on O-RAN specifications, enhance integration between the O-RAN SC and the OpenAirInterface (OAI), enhance integration with Intel FlexRAN ™ reference software, provide a more robust platform for RAN Intelligent Controller (RIC) application developers, and introduce an improved simulator for researchers. These achievements highlight the O-RAN SC's commitment to advancing open-source innovation in the RAN industry.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store