Organiser: IPMMA (Indian Pharmaceutical Machinery Manufacturers’ Association), GPE Exhibitions Time:July 9–11, 2026 Address:HITEX Exhibition Centre, Izzat Nagar, Hyderabad 500 032, A.P. Exhibition hall:Hyderabad International Trade Exposition Centre (HITEX) Product range: Machinery & Equipment: Pharmaceutical processing and packaging, laboratory equipment Materials: Packaging materials and consumables, glassware, laboratory ware and consumables Chemicals & Pharmaceuticals: Active Pharmaceutical Ingredients (APIs), excipients, laboratory reagents and chemicals, bulk formulations, active pharmaceutical substances Project Management: Utilities, consulting, turnkey services, eco-friendly products and services Trade Promotion: Trade associations, institutions, publications Others: Pharmaceutical production services, contract manufacturing, CRO/CDMO service providers, research institutions, testing laboratories and related services About Pharma Pro & Pack Expo: Pharma Pro & Pack Expo is the largest, most leading, and most influential pharmaceutical packaging exhibition in South Asia. Co-organized by the Indian IPMMA Association and GPE Exhibitions, the event has received strong support from official media and India’s healthcare industry. Since the establishment of ...
Drugdu.com expert’s response: The core logic is: risk-based classification → strict pre-market review → continuous post-market surveillance, forming a full lifecycle closed loop. I. Classification: Risk Determines Regulatory Intensity Under the Regulation on the Supervision and Administration of Medical Devices, devices are divided into three classes: Class I (Low Risk): Filing system, formal review only. Examples: medical cotton swabs, surgical gowns. Class II (Moderate Risk): Registration system, reviewed and approved by provincial drug administration. Examples: blood pressure monitors, CT scanners. Class III (High Risk): Registration system, reviewed and approved by the National Medical Products Administration (NMPA). Examples: cardiac stents, artificial joints. Higher risk means stricter review — classification itself is the first safety filter. II. Pre-Market Approval: Four Core Gates Taking Class II and III as examples: Gate 1: Product Technical Requirements & Testing Must complete biological evaluation, electrical safety, performance testing, etc., to prove the product itself is qualified. Class III ...
Drugdu.com expert’s response: No. You don’t need a “license” for Class II medical devices — you only need to file a record . To be precise, the term “Class II Medical Device Operation License” itself is incorrect. According to Article 30 of the Medical Device Supervision and Administration Regulations: Class I: No license required, no filing required Class II: No license required, but filing is mandatory. You obtain a Class II Medical Device Operation Filing Certificate Class III: License required. You apply for a Medical Device Operation License So the correct procedure for Class II is: submit filing materials to the municipal-level drug administration department where the enterprise is located. If materials are complete and meet requirements, the certificate is issued on the spot. The filing certificate has no fixed expiry date. When enterprise information changes, a change filing must be processed. When operations cease, the filing must be actively cancelled.
Organiser:Informa Markets Time:July 8–10, 2026 Address:Queen Sirikit National Convention Center, 60 Ratchadaphisek Rd, Khlong Toei, Bangkok 10110, Thailand Exhibition hall:Queen Sirikit National Convention Center Product range: APIs (Active Pharmaceutical Ingredients): Vitamins, hormones, sulfonamides, antipyretics & analgesics, tetracyclines, amino acids & derivatives, chloramphenicols, digestive system drugs, other anti-infectives, penicillins, aminoglycosides, lincosamides, cardiovascular drugs, antiparasitics, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western chemical APIs Packaging & Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, drug production equipment & technology, drug packaging equipment, drug packaging materials, drug production, cleaning & disinfection systems, and laboratory instrument systems Pharmaceutical Products: Various proprietary Chinese medicines, Western medicines, new drugs, various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal & plant extracts, veterinary drugs, food ingredients & additives, etc. About CPhI South East Asia: CPhI South East Asia is the most authoritative pharmaceutical ingredients exhibition in ...
On June 9, 2026, Jiangsu Beijietai Biotechnology Co., Ltd., a wholly-owned subsidiary of Shutaishan, received the Drug Registration Certificate for Bomitai Enzyme Alpha for Injection (trade name: Bojia Ning) issued by the National Medical Products Administration. This drug is a Class 1 therapeutic biological product manufactured domestically, with the approval number S20260040. This approval is conditional, and its indication is for the treatment of bleeding in adult patients with congenital hemophilia A or B whose factor VIII or IX inhibitors are >5 Bethesda units (BU). Hemophilia is an X-linked recessive inherited bleeding disorder, characterized by male onset and female carrier status. Hemophilia can be divided into hemophilia A and hemophilia B. Hemophilia A is characterized by a deficiency of clotting factor VIII (FVIII), while hemophilia B is characterized by a deficiency of clotting factor IX (FIX), both caused by mutations in the corresponding clotting factor genes. The clinical feature of ...
On June 9th, Zai Lab’s first neurological product, Xanomelide Traxodium Chloride Capsules (Kagero® ) , was shipped from Suzhou and began supplying hospitals and pharmacies in multiple provinces and cities across China. On the same day, the drug was prescribed for the first time nationwide at Beijing Anding Hospital affiliated with Capital Medical University, and subsequently reached schizophrenia patients in over 30 cities and nearly 50 hospitals across the country. Ni Qian, member of the Party Working Committee and deputy director of the Management Committee of Suzhou Industrial Park, said: Zai Lab is a key witness to and participant in the booming development of the biopharmaceutical industry in the park. Ten of its innovative products, including Xanomeprazole and Traxolium chloride capsules , have been approved for marketing in China, demonstrating strong resilience and innovation capabilities. We will continue to support companies like Zai Lab, encouraging them to deepen their presence ...
On June 9, the NMPA website showed that Tianguangshi MIL62 (generic name: Oxtuzumab β injection ) has been approved for a new indication: the treatment of primary membranous nephropathy (PMN) , becoming the world’s first drug approved for this indication. MIL62 is an innovative third-generation CD20 antibody drug independently developed by Tianguangshi . It was approved for marketing in China in February 2026 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) . It is the world’s first CD20 antibody for the treatment of this disease and also the first domestically produced drug in China in this field. On June 4, 2026, Tianguangshi and Everest Medicines reached a commercialization licensing agreement for the drug and signed a relevant agreement, authorizing the clinical development and commercialization rights of MIL62 in the Asia-Pacific region (Southeast Asia, India, South Korea, Australia, New Zealand, Hong Kong, Macau and Taiwan) . According to the relevant ...
Parkinson’s disease is a common neurodegenerative disease that causes great inconvenience to patients’ lives. Especially in the middle and late stages, patients often face severe deterioration of motor function, such as recurrent episodes of muscle stiffness, tremors, and difficulty moving, which greatly reduces their quality of life. On June 9, 2026 , according to the latest information on the official website of the National Medical Products Administration ( NMPA ) of China, salfedipine mesylate tablets , submitted by Qilu Pharmaceutical Co., Ltd. under Category 4 of chemical drug registration , were approved for marketing and are considered to have passed the evaluation. It is mainly used to treat idiopathic Parkinson’s disease in patients who experience motor fluctuations after receiving stable doses of levodopa. Safinamide mesylate tablets are a selective inhibitor of monoamine oxidase type B (MAO-B) with a unique mechanism of action that reduces dopamine degradation and regulates glutamate release, ...
On June 9, Huadong Medicine (000963.SZ) announced that its application for a new indication for Ellansé® S – type , an imported Class III medical device injectable polycaprolactone microsphere facial filler , for subcutaneous or suprapeophyte implantation in the forehead to improve moderate to severe forehead contour defects, has been formally accepted by the National Medical Products Administration (NMPA). This application is expected to expand its scope from nasolabial folds to the forehead contour area, strengthening the company’s multi-indication competitive advantage in the PCL regeneration field and enriching its supply of refined facial anti-aging solutions, further releasing the product’s clinical value. Ellansé® is one of the core products of Huadong Medicine Aesthetics , and is known as the ” Youthful Needle” due to its outstanding triple effect of “immediate filling + long-lasting maintenance + natural metabolism”. As the first approved imported PCL high-end facial filler in China, the application for ...
Recently , a strategic partner of Shanghai Newyao Baike Medical Technology Co., Ltd. (Shanghai Newyao Baike Medical Technology Co., Ltd.) received formal approval from the U.S. Food and Drug Administration (FDA) for its Inpacpen DCP® disposable adjustable-dose cartridge injection pen, successfully approved for use in its liraglutide injection! This is the first drug-device combination product approved by the FDA using a pen syringe manufactured in China, marking a historic step for China’s high-end drug delivery devices in entering the international market with the highest regulatory standards. It is also the company’s third product to receive approval in the U.S. market, following the Safetis® needle protector and the InpacJector® Luer pre-filled syringe (COP)!A historic breakthrough in China’s drug-medicine combination products Liraglutide, a blockbuster GLP-1 drug, has long relied on European and American suppliers for its delivery devices. This approval signifies that Chinese-made pen injectors have officially entered the world’s most stringent ...
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