Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking. - Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.

Start Date10 Dec 2022

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

JPRN-UMIN000048512

/ CompletedNot Applicable

Blood transfer confirmation test of beta-caryophyllene by single inhalation ingestion associated with smoking of beta-caryophyllene - Blood transfer confirmation test of beta-caryophyllene by single inhalation ingestion associated with smoking of beta-caryophyllene

Start Date01 Dec 2021

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

JPRN-UMIN000048510

/ CompletedNot Applicable

Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV - Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV

Start Date01 Sep 2021

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

100 Clinical Results associated with Towa Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Towa Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Towa Pharmaceutical Co., Ltd.

17 Jan 2025·Organic Process Research & Development

Exploration for Chemical Filter Cartridges that Can Reduce Nitrogen Oxides, a Common Factor in the Formation of Nitrosamines

Author: Akasaki, Kanenao ; Yokoi, Rintaro ; Hirai, Kyoko ; Suzuoki, Kazuya ; Nomura, Ryota ; Taniguchi, Takahiko ; Uchikawa, Osamu

News of "carcinogenic nitrosamines contained in pharmaceutical products" have made headlines around the world, and risk avoidance measures have been demanded by regulatory bodies as a consequence.However, it is not easy to completely eliminate contamination with nitrosamines because of a wide variety of potential causes of contamination.As a common factor involved in the formation and contamination of nitrosamines, we focused on the extremely small amount of nitrogen oxides in the air and searched for ways to reduce them.As a result, we found that the chem. filter cartridges (made by NIPPON MUKI Co., Ltd.) decreased nitrogen oxides from the tens of ppb level to the several ppb levels.We expect that our finding will be used as one useful strategy to control the nitrosation caused by repeated exposure of the drug substances and drug products to small amounts of nitrogen oxides during processing and lead to the supply of safe and reliable pharmaceutical products.

14 Jan 2025·ACS Omega

Development of a Simultaneous Analytical Method for Amines Corresponding to 10 Typical Nitrosamines

Author: Kondo, Kanako ; Hoshiyama, Takehiro ; Uchikawa, Osamu ; Fukuda, Shohei

Regulatory authorities in various countries have successively issued notices and guidance to pharmaceutical manufacturers and distributors to evaluate the risk of contamination of nitrosamines in pharmaceutical products and to take appropriate measures.Anal. of nitrosamines in pharmaceutical products is not easy due to the large number of foreign substances, and the risk of contamination is determined by first conducting a desk investigation of the manufacturing process of the APIs or pharmaceutical products.However, a desk investigation may miss the risk since this method is not based on actual measurements.Therefore, in addition to conventional desk-based investigation, a new method is required to pick up risks that cannot be covered by a desk investigation.Nitrosamines are known to be formed by the reaction of amines with nitrosating agents such as nitrite.In the case of small alkyl nitrosamines such as NDMA and NDEA, the origin of the amines is mostly residual amines in the APIs.Residual amines in the APIs are a potential nitrosamine contamination risk, although the extent of that risk has rarely been reported.In this study, we developed and validated a simultaneous anal. method for amines corresponding to 10 typical small alkyl nitrosamines.Good linearity was obtained in the range of 0.003 to 10 μg/mL for MPA, 0.003 to 2 μg/mL for DIPA and DBA, 0.003 to 1 μg/mL for MeP, DEA, EIPA, and DPA, and 0.003 to 0.2 μg/mL for DMA, MOR, and MBA.The limits of quantitation and detection were 0.003 and 0.001-0.003 μg/mL, resp.The recovery rates ranged from 70 to 130% for 121 APIs and were more than 40% for 83 APIs.Repeatability was also good, with %RSD < 15%.Although the correlation between the amount of amines detected in the APIs and the nitrosamines in the pharmaceutical products is under investigation, we expect that this anal. method will be used to determine the residual amine contents in APIs and contribute to the risk assessment of the nitrosamine contamination.

01 Jan 2025·Journal of Pharmaceutical Sciences

Bridging the gap between in vitro and in vivo solubility-permeability interplay

Article

Author: Oda, Takamasa ; Oikawa, Michinori ; Ito, Ryo ; Arima, Kanako ; Ohyama, Kaoru ; Kawakami, Kohsaku ; Matsuura, Satoru ; Fushimi, Masahiro ; Okudaira, Takeyuki

Use of solubilization carriers for poorly soluble drugs may disturb transmembrane absorption by lowering the activity of drug molecules, which is known as the solubility-permeability interplay. However, although many in vitro studies have indicated the negative impacts of use of solubilization carriers for oral absorption, in vivo studies that showed the interplay effect are limited. This study provides systematic in vitro, in situ, and in vivo investigation of the interplay effect of cyclodextrin using dexamethasone as a model drug. The evaluation methods included permeation through polymeric, artificial lipid, cell, and intestinal closed-loop membranes. Then, the results were compared with oral administration studies in mice and dogs. Although the interplay effect was clearly observed in the in vitro studies, no obvious interplay was found in the in vivo studies, suggesting that the interplay effect is more prominent in the in vitro permeation studies. Absence of in vivo interplay was attributed to the dilution effect in the gastrointestinal tract, interaction of the drug with living components, and clearance of the drug after membrane permeation. Overall, this investigation clearly demonstrated the applicability and limitations of in vitro permeation studies for predicting the interplay effects of solubilizers after the oral administration.

News (Medical) associated with Towa Pharmaceutical Co., Ltd.

04 Jan 2024

·www.sunsho.co.jp

Sunsho Pharmaceutical completes acquisition of Kamata Co., Ltd.

Sunsho Pharmaceutical Co., Ltd. (HQ: Fuji City, Shizuoka Prefecture; CEO: Row Imamura), a leader in capsule development and manufacturing, is pleased to announce the successful completion of its acquisition of “Kamata Co., Ltd.” (HQ: Tokyo; CEO: Izumi Kamata), a prominent health food contract manufacturer specializing in soft capsules. Initially announced on December 11, 2023, Sunsho Pharmaceutical Co., Ltd. finalized the acquisition of Kamata Co., Ltd. as planned on January 5th, 2024. Sunsho Pharmaceutical Co., Ltd. committed to "being the best partner for everyone involved with Sunsho Pharmaceutical," is dedicated to improving global health through innovative development in health foods, pharmaceuticals, general foods, and general merchandise. This acquisition marks a significant milestone, positioning Kamata Co., Ltd. as a wholly owned subsidiary of Sunsho Pharmaceutical Co., Ltd. By combining the expertise and resources of Sunsho Pharmaceutical Co., Ltd. and Kamata Co., Ltd., the unified entity is poised to pioneer novel products and will continue to deliver the best products, services, and value-added solutions to our valued customers.

Acquisition

01 Aug 2022

·www.prnewswire.com

Breckenridge Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®)

BERLIN, Conn., Aug. 1, 2022 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®). This product was developed in collaboration with Natco Pharma Limited. Breckenridge received final approval for the 60mg/1.5mL (40mg/mL) strength. Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time. According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022. About Breckenridge: Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve. About Natco: Natco Pharma Limited is a global generic pharmaceutical research, development, manufacturing and marketing company. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe, including the United States. Natco focuses on the development and manufacturing of oncology and other specialty pharmaceuticals. For further information, please contact: Breckenridge Pharmaceutical, Inc. Robert Gasparino, Associate Vice President – Business Development Tel: 860-828-8140 E-mail: [email protected] *All brand names and trademarks are the property of their respective owners. SOURCE Breckenridge Pharmaceutical, Inc.

16 Dec 2021

·www.carlyle.com

Carlyle Enters into Definitive Agreement to Sell Sunsho Pharmaceutical Co., Ltd to Towa Pharmaceutical Co., Ltd.

Tokyo, Japan, December 17, 2021 – CJP SP Holding, L.P., an investment fund operated and managed by global investment firm Carlyle (NASDAQ: CG), signed an agreement to sell 100% of its investment in Sunsho Pharmaceutical Co., Ltd (“Sunsho Pharmaceutical”), a contract manufacturing company of health & nutrition (“H&N”) and pharmaceutical products, to Towa Pharmaceutical Co., Ltd. (“Towa Pharmaceutical”), a company specializing in research and development, production, and marketing of generic drugs. The transaction is expected to be completed in February of 2022. Headquartered in Shizuoka, Sunsho Pharmaceutical is one of the largest contract manufacturers in Japan for soft capsules, seamless capsules, and other dosage forms for H&N and pharmaceutical use. The company focuses on producing absolute quality products and applies state-of-the-art contract manufacturing technology to create cutting-edge formulations and capsules. CJP SP Holding, L.P. acquired a 100% stake in Sunsho Pharmaceutical in August of 2014 through Carlyle’s third Japan buyout fund, Carlyle Japan Partners III, having recognized the company’s strong growth potential as a contract manufacturer in a steadily growing H&N market in Japan. Carlyle also saw the potential for value creation with Sunsho Pharmaceutical and within the H&N market in Japan by leveraging its local team knowledge, global platform strengths and deep experience in the healthcare and consumer sectors. Through Carlyle’s ownership, Sunsho Pharmaceutical strengthened its management structure and governance, initiated the launch of a new factory and research and development facility to enhance production capabilities, diversified its business portfolio to cater to new customers, and significantly increased its global revenues by bolstering and expanding its overseas business. Carlyle also worked closely with Sunsho Pharmaceutical’s management team to help drive innovation and co-create new value-add products and solutions with customers. Carlyle will transition full ownership to Towa Pharmaceutical to support Sunsho Pharmaceutical’s next phase of growth. Carlyle has made 31 investments in Japan since entering into the market in 2000 and this will be the 20th exit to date. Carlyle has a well-established history of investing in the healthcare sector, both in Japan and globally, investing more than US $14.7 billion of equity in over 80 deals in the global healthcare sector as of September 30, 2021. Healthcare investments in Japan include Qualicaps Co., Ltd., and Solasto Corporation.

Acquisition

100 Deals associated with Towa Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Towa Pharmaceutical Co., Ltd.

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Pipeline Snapshot as of 22 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Kallidinogenase(Towa Pharmaceutical) ( KNG1 )	Poor peripheral circulation More	Approved
Aluminum hydroxide/Magnesium Hydroxide ( Proton pump )	Stomach Ulcer More	Approved
Tobramycin ( 30S subunit )	Cystitis More	Approved
Antibiotics-Resistant Lactic Acid Bacteriae(Towa Pharmaceutical)	Gastrointestinal Diseases More	Approved
Betamethasone Valerate/Gentamicin Sulfate	Impetigo More	Approved

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