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NewswireTODAY - /newswire/ -
Osaka, Japan, 2026/03/02 - Ono Pharma Announces Transfer of the Manufacturing and Marketing Approval Authorization for Opalmon® Tablets and Prostandin® Ointment to Daito Pharmaceutical Co., Ltd - Daitonet.co.jp / ONO-Pharma.com.
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Ono Pharmaceutical Co., Ltd (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) announced today that it has agreed to transfer the manufacturing and marketing approval authorization (MMAA) for Opalmon®* Tablets 5 μg (generic name: Limaprost Alfadex; "Opalmon Tablets") and Prostandin®* Ointment 0.003% (generic name: Alprostadil Alfadex; "Prostandin Ointment ") which Ono has retained to Daito Pharmaceutical Co., Ltd. (Headquarters: Toyama, Japan; President and CEO: Hiroshi Matsumori; "Daito").
The companies are currently proceeding with the transfer procedures, including the transfer of manufacturing technology, and the MMAA transfer is scheduled to be completed by the end of November 2026.
Daito has long been entrusted with the formulation manufacturing and some of the packaging processes for Opalmon Tablets. Through this agreement, manufacturing sites will be consolidated, and the product will remain available, with the aim of ensuring a highly stable supply throughout the world.
* Opalmon and Prostandin are registered trademarks of Ono, but will be transferred to Daito along with the succession of MMAA.
Product to be transferred:
Product name - Therapeutic category
OPALMON® Tablets 5 μg - Oral prostaglandin E1 derivative formulation.
PROSTANDIN® OINTMENT 0.003% - Prostaglandin E1 formulation.
1. Opalmon Tablets
Product name: OPALMON® Tablets 5 μg
Generic name: Limaprost Alfadex
Therapeutic category: Oral prostaglandin E1 derivative formulation
Content: 5 μg
Dosage form: Uncoated tablet
Indication
• Improvement of ischemic symptoms such as ulcers, pain, and coldness associated with thromboangiitis obliterans.
• Improvement of walking ability and subjective symptoms (lower limb pain and lower limb numbness) associated with acquired lumbar spinal canal stenosis (patients with normal SLR test results and bilateral intermittent claudication).
2. Prostandin Ointment
Product name: PROSTANDIN® OINTMENT 0.003%
Generic name: Alprostadil Alfadex
Therapeutic category: Prostaglandin E1 formulation
Content: 30 μg (0.003%) of Alprostadil per gram as Alprostadil Alfadex
Dosage form: Ointment
Indication
• Bedsores
• skin ulcers (burn ulcers, diabetic ulcers, leg ulcers, and postoperative ulcers)
Daito Pharmaceutical Co., Ltd
Daito (Toyama, Japan) (daitonet.co.jp) is a global pharmaceutical company engaged in activities ranging from research and development to manufacturing, with two core pillars: active pharmaceutical ingredients and formulations. Since its founding in 1942, it has continued to manufacture and sell active pharmaceutical ingredients and formulations for prescription and over-the-counter drugs, and has established business relationships with over 90% of pharmaceutical companies in Japan.
About Ono Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd (ono-pharma.com) delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care.
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