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Indian pharma targets specialty and chronic therapies in China as NMPA approvals show focused API mix
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Shardul Nautiyal, Mumbai
August 19 , 2026
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Indian pharmaceutical companies are increasingly focusing on higher-value chronic and specialty medicines in China, with 2025 National Medical Products Administration (NMPA), China approval data showing a concentration of registrations across oncology, cardio-metabolic, CNS and neurology segments. The pattern indicates a shift beyond volume-driven generic medicines towards differentiated products and long-term therapies in the Chinese market.
The NMPA is the key agency in China that regulates drugs, medical devices, and cosmetics. It protects public health by testing products, approving new treatments, and setting safety rules.
According to the NMPA data, a limited group of active pharmaceutical ingredients (APIs) accounted for multiple approvals involving Indian marketing authorisation holders (MAHs) during 2025. The leading ingredients included venlafaxine hydrochloride, lansoprazole, tadalafil, oxcarbazepine, irbesartan, deferasirox, teriflunomide, tizanidine hydrochloride, nilotinib hydrochloride hydrate and sildenafil citrate.
The NMPA data indicate that oncology remained an important area of focus for Indian companies, with products containing olaparib, regorafenib and nilotinib receiving multiple approvals across companies and strengths. These registrations point to continued interest in supplying cancer therapies to the Chinese market, where specialty medicines represent an important component of pharmaceutical demand.
The cardio-metabolic segment also featured prominently, with dapagliflozin, atorvastatin, irbesartan and bosentan among the active ingredients represented in the 2025 approval landscape. Dapagliflozin, an SGLT2 inhibitor, along with medicines for lipid management and hypertension, reflects the continued importance of chronic disease therapies in Indian companies' China portfolios.
CNS and neurology products formed another significant group. clobazam, oxcarbazepine, venlafaxine sustained-release formulations, fingolimod and tizanidine were among the ingredients highlighted in the 2025 data. The presence of these products indicates continued registration activity in therapies used for neurological and psychiatric conditions.
The NMPA data also showed activity in anti-infective medicines, including caspofungin, polymyxin B and voriconazole. A combination nasal spray containing mometasone and olopatadine, used for respiratory and allergic indications, further illustrates the range of products being pursued by Indian companies.
The company-level data reveal distinct therapeutic portfolios among leading Indian MAHs. Natco and Dr Reddy's showed greater representation in oncology and CNS/neurology products, while Hetero and Aurobindo featured more prominently in cardio-metabolic and gastroenterology-related medicines. Gland and several mid-sized companies contributed significantly to anti-infective products and complex injectables.
These therapeutic patterns suggest that companies are aligning their Chinese portfolios with their existing manufacturing, development and partnering capabilities. Rather than concentrating solely on high-volume generic products, Indian MAHs are increasingly seeking opportunities in chronic-care medicines, specialty therapies and complex formulations.
The trend builds on the therapeutic pattern observed in the 2023-24 data, when quetiapine fumarate, tacrolimus hydrate, tadalafil, levetiracetam and mycophenolate sodium were among the key APIs by approval count. Those products represented areas including psychiatry, transplant medicine, erectile dysfunction and neurology.
The 2025 approval mix, according to the NMPA, therefore points to a continuing emphasis on medicines with longer-term and specialised therapeutic applications. The objective for Indian pharmaceutical companies is to expand their presence in the Chinese market by combining established generic capabilities with products in higher-value therapeutic segments, while responding to demand for chronic disease and specialty care medicines.
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