media – Page 15 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Good news! Chang Le Pharmaceutical’s Bumetanide Injection has received approval for its Supplemental Drug Application

Recently, Chang Le Pharmaceutical, a subsidiary of Lianhuan Pharmaceutical, received the “Approval Notice for Supplementary Drug Application” issued by the National Medical Products Administration. Bumetanide injection was successfully approved, marking a new stage in the company’s production and supply capacity and quality management level in the field of diuretics, and injecting strong momentum into the company’s high-quality development. Bumetanide injection is a commonly used, potent diuretic in clinical practice, widely applied in the treatment of edematous diseases, hypertension, prevention of acute renal failure, and hyperkalemia, demonstrating significant clinical value. This approval includes a new 1ml:0.5mg product specification, along with simultaneous changes to the manufacturing process, production volume, and packaging materials and containers. Since the project’s inception, Chang Le Pharmaceutical has assembled a professional R&D and production team, conducting systematic pharmaceutical research over several months. Adhering strictly to national drug development principles, the team has carried out comprehensive and in-depth experimental ...
- Source: drugdu
- 84
- April 8, 2026
New Drug Launch | Gan & Lee Pharmaceuticals’ Sitagliptin Metformin Tablets (II) Approved

Beijing, China, April 7, 2026 – Gan & Lee Pharmaceuticals Inc. (hereinafter referred to as “Gan & Lee Pharmaceuticals”, stock code: 603087.SH) announced that its wholly-owned subsidiary, Gan & Lee Pharmaceuticals Shandong Co., Ltd., recently received a drug registration certificate for sitagliptin metformin tablets (II) issued by the National Medical Products Administration (hereinafter referred to as “NMPA”) (Acceptance No.: CYHS2403373, Certificate No.: 2026S00914, Drug Approval No.: H20263765). Sitagliptin and metformin tablets (II) are a combination oral hypoglycemic agent. Each tablet contains 50 mg of sitagliptin phosphate (calculated as sitagliptin) and 850 mg of metformin hydrochloride. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that stimulates insulin release in a glucose-dependent manner and reduces glucagon levels by increasing the level of active incretin. Metformin inhibits hepatic gluconeogenesis, reduces glucose absorption in the small intestine, and improves peripheral tissue sensitivity to insulin by increasing glucose uptake and utilization. This product, in combination with ...
- Source: drugdu
- 85
- April 8, 2026
$400 Million! AI Unicorn Anthropic Acquires Coefficient Bio

On April 7, according to The Information and Eric Newcomer, AI giant Anthropic is continuing its push into healthcare with the acquisition of Coefficient Bio, a previously little-known AI biotechnology startup, in a $400 million stock deal. The acquisition was confirmed by people familiar with the matter, and Coefficient’s PitchBook page also reflects the $400 million transaction.In early April, Anthropic, the U.S. AI unicorn, announced the completion of a $30 billion Series G funding round, valuing the company at $380 billion—a sharp increase from its $183 billion valuation in the previous Series F round. In less than three years since its founding, it has achieved $14 billion in annualized revenue, with growth of more than 10-fold each year over the past three years. Aris Theologis is CEO and co-founder of Coefficient. He previously served as Chief Business Officer of Evozyne and Vice President of Paragon Biosciences. He also has extensive ...
- Source: drugdu
- 74
- April 8, 2026
【EXPERT Q&A】What are the compliance requirements for labels in the EU medical device CE audit?

Drugdu.com expert’s response: In the EU Medical Device CE Certification review, compliance requirements for labeling are of utmost importance to ensure that products conform to relevant regulations and standards. Below is a detailed summary of these requirements: I. Basic Label Content Requirements Product Identification Information: Labels should include essential information such as the product model, batch number, and expiration date to enable regulatory authorities and consumers to accurately understand the product’s information and performance characteristics. Manufacturer Information: The label should clearly indicate the manufacturer’s name, address, as well as the product model and serial number (if applicable). This information aids in tracing the product’s origin and compliance. CE Mark: Products must bear the CE mark in a prominent location, which is a mandatory indication that the product complies with relevant EU regulations. The CE mark should be clearly visible and resistant to wear. Its color is typically white letters on ...
- Source: drugdu
- 105
- April 8, 2026
SINOPHEX SHANGHAI

Organiser：Reed Sinopharm Exhibitions Time：May 13 – May 15, 2026 Address：No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：National Exhibition and Convention Center (Shanghai) Product range: API (Active Pharmaceutical Ingredient) equipment Decoction piece equipment Pharmaceutical packaging equipment Formulation equipment Other pharmaceutical manufacturing equipment Laboratory equipment and consumables Electronic supervision systems Pharmaceutical grinding equipment Environmental protection and purification equipment Plastic machinery About SINOPHEX： The Shanghai International Pharmaceutical Equipment Exhibition (SINOPHEX, referred to as the Pharmaceutical Equipment Exhibition) serves as a professional platform for learning, communication, and cooperation within China’s pharmaceutical equipment industry. SINOPHEX consistently focuses on industry hotspots such as green production, continuous-flow production, and intelligent manufacturing, providing information and technological support to help Chinese pharmaceutical raw material and formulation manufacturers achieve the goals outlined in “Made in China 2025.” As the industry advances toward Industry 4.0, the further digitalization of production processes is an inevitable trend and ...
- Source: drugdu
- 112
- April 7, 2026
【EXPERT Q&A】How should the biocompatibility of medical devices be carried out?

Drugdu.com expert’s response: The development of medical device biocompatibility requires adherence to a systematic process, integrating international standards (such as the ISO 10993 series) and domestic regulations (such as the GB/T 16886 series), and implementing it in stages from preliminary preparation to continuous monitoring. The specific steps are as follows: I. Preliminary Preparation and Risk Assessment Clarify Device Information Determine the intended use (e.g., implantation, contact with blood/mucous membranes/skin), duration of contact (short-term, long-term, or permanent), and material composition (main structure, coatings, connecting components, etc.). Example: A cardiac stent requires long-term implantation in blood vessels, necessitating a focus on evaluating tissue compatibility and blood compatibility. A disposable syringe requires attention to skin irritation and cytotoxicity. Identify Potential Risks Analyze the biological reactions that materials may trigger, such as allergies, cytotoxicity, local inflammation, coagulation, or hemolysis. Example: Nickel-containing metal materials may cause allergic reactions; rough-surfaced materials may damage tissue cells. Determine ...
- Source: drugdu
- 108
- April 6, 2026
【EXPERT Q&A】What is the specific process for obtaining a medical device product registration certificate?

Drugdu.com expert’s response: The Process for Obtaining a Medical Device Product Registration Certificate Involves Multiple Steps, Detailed as Follows: I. Preliminary Preparation and Classification Confirmation Product Classification Determination: Based on the Medical Device Classification Catalog and classification criteria, the category is determined by considering factors such as the intended use and mechanism of action of the product. For example, blood glucose test strips fall under Class II, while artificial heart valves are classified as Class III. If no matching category can be found in the existing catalog, a classification determination must be conducted beforehand. Selection of Registration Pathway: Domestic enterprises should proceed with the registration process, while imported products must appoint a domestic agent. For renewal of registration, applications should be submitted six months prior to the expiration of the certificate. Preparation of Technical Requirement Documents: These documents should cover product standards, performance indicators, and test reports, referencing relevant standards. For instance, orthopedic implants must ...
- Source: drugdu
- 102
- April 3, 2026
CMEF SHANGHAI

Organiser：Reed Sinopharm Exhibitions Time：April 9 – April 12, 2026 Address：No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：National Exhibition and Convention Center (Shanghai) Product range: Medical Imaging Zone: Radiology products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Zone: Hybrid operating rooms, integrated operating room solutions, surgical instruments, anesthetic machines, ventilators, patient monitors, operating room engineering, surgical lights, pendant systems, etc. In Vitro Diagnostics Zone: Total laboratory solutions, clinical diagnostic equipment, diagnostic reagents, point-of-care testing (POCT), home diagnostic devices, etc. Rehabilitation and Physiotherapy Zone: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physical therapy equipment, medical high-frequency equipment, etc. Orthopedics Zone: Orthopedic implant consumables across three major categories (joints, trauma, spine), orthopedic surgical instruments and equipment, bone power tools, and other orthopedic-related products. Medical Informatics Zone: System integrators, mobile healthcare, hospital management, quality control, clinical and other hospital information management systems, IT equipment ...
- Source: drugdu
- 114
- April 2, 2026
【EXPERT Q&A】What testing and certification are required for the export of pharmaceutical products to Japan

Drugdu.com expert’s response: Pharmaceutical products exported to Japan must obtain certification from Japan’s Ministry of Health, Labour and Welfare (MHLW) and meet the following testing and certification requirements: I. Core Certification Requirements 1. Drug Certification Basis of Regulations: Primarily based on the Pharmaceutical and Medical Device Act (Pharmaceutical Affairs Law) and the Food Sanitation Act. Testing Content: Includes ingredient analysis, efficacy evaluation, and safety testing, covering physical and chemical property testing, biological activity testing, and contaminant testing, among others. Certification Process: Submit detailed technical documentation and ingredient descriptions of the product. Provide production process flow and quality control measures. Submit previous testing reports and certificates of compliance. Provide relevant clinical trial data (if applicable). 2. Medical Device Certification PMDA Certification: Medical devices must obtain certification from the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body for pharmaceuticals and medical devices, to ensure compliance with Japanese safety, efficacy, and quality ...
- Source: drugdu
- 117
- April 1, 2026
Sinovac Biotech and Changzhou Pharmaceutical Factory have reached a strategic cooperation agreement and signed an exclusive licensing agreement for two cardiovascular drugs in overseas markets.

Recently, Sinovac BiotechSinovac Biotech Co., Ltd. (hereinafter referred to as ” Sinovac Biotech”)(Stock code 688136.SH) and Shanghai PharmaceuticalsChangzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as “Changzhou Pharmaceutical Factory”), a subsidiary of the Group, held a strategic cooperation signing ceremony and an exclusive licensing agreement for two products, ticagrelor tablets and rosuvastatin calcium tablets, in several European countries. Leveraging Sinovac Biotech ‘s mature overseas commercialization network and Changzhou Pharmaceutical Factory’s high-quality product R&D and manufacturing capabilities, the two parties will join hands to expand into the European market, bringing domestically produced cardiovascular drugs to more patients. Enriching the European product line and continuously cultivating the major market It is understood that both products launched through this collaboration have been approved in China and the United States and are currently undergoing registration applications in several European countries. The cooperation covers markets including Germany, Spain, the Netherlands, Italy, and France. Ticagrelor tablets ...
- Source: drugdu
- 225
- March 31, 2026

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