The U.S. is introducing a sharp split in pharmaceutical tariffs, with certain patented drugs facing a 100% duty while selected specialty medicines can qualify for 0% tariffs. With India included among the eligible jurisdictions, the move could create a different impact across Indian pharma companies. In this article, we look at which listed Indian pharma stocks have exposure to the specialty segments covered by the exemption and how relevant the opportunity could be.
US Pharma Tariff Split: What Has Changed?
The U.S. has introduced a two-tier tariff structure for pharmaceutical imports, creating a major distinction between patented medicines and selected specialty drugs. From September 29, 2026, certain patented pharmaceutical products and related ingredients can face a 100% tariff, while qualifying specialty medicines from eligible jurisdictions, including India, can receive a 0% tariff.
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The exemption is not for all medicines. The U.S. Commerce Department has specifically included orphan drugs, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapies, antibody-drug conjugates (ADCs), certain CBRN medical countermeasures and animal-health products. The products must satisfy the conditions laid out by Commerce.
An important point for Indian pharma companies is that generic medicines and their associated ingredients are currently outside the Section 232 pharmaceutical tariffs. This means the biggest potential benefit from the new exemption is for companies with exposure to differentiated and specialty medicines rather than conventional generics.
Commerce has also opened a process through which companies can request tariff relief for products that meet an urgent U.S. health need. Such applications will be reviewed individually based on factors including the product, manufacturer, country of origin and medical requirement.
Indian stocks with relevant exposure
Zydus Lifesciences – Orphan-drug exposure
Zydus has a direct connection to one of the exempt categories through Zycubo (copper histidinate). The U.S. FDA approved Zycubo on January 12, 2026, as the first treatment for Menkes disease in pediatric patients, and the FDA’s orphan-drug database lists it as an orphan medicine. Zydus reported Q1 FY27 revenue of ₹8,017 crore, while North America formulations revenue was about ₹3,098 crore.
Mankind Pharma – Fertility and specialty biologics
Mankind‘s exposure comes mainly through Bharat Serums and Vaccines (BSV), acquired for ₹13,768 crore. BSV operates across fertility, women’s health, critical care and specialty biologics, with products based on recombinant technology, niche biologics and immunoglobulins. Its fertility portfolio includes recombinant FSH, recombinant HCG and HMG. In Q1 FY27, Mankind reported revenue of ₹4,031 crore, up 12.9% YoY, while PAT increased 29.1% to ₹574 crore.
Gland Pharma – Fertility exposure, but generic
Gland Pharma received U.S. FDA approval for Cetrorelix Acetate for Injection, a fertility drug used during controlled ovarian stimulation. The company described itself as a generic injectable-focused pharma company and said the reference product had U.S. sales of about $129 million in the 12 months ended February 2024.
This distinction matters because generic medicines are currently outside the Section 232 tariff regime, so Cetrorelix should not automatically be considered a new tariff beneficiary. Gland’s Q1 FY27 revenue was about ₹1,800 crore, while PAT stood at around ₹317 crore.
Sun Pharma – Specialty and orphan-drug pipeline
Sun Pharma has a large innovative-medicines business, including Fibromun, which has received U.S. FDA orphan-drug designation for soft-tissue sarcoma and glioma.
For Q1 FY27, Sun reported sales of ₹15,184 crore, while Global Innovative Medicines sales reached $351 million, accounting for 21.9% of sales. However, Fibromun remains in development, so the tariff framework is currently more relevant to Sun’s specialty pipeline than to an immediate earnings benefit.
Piramal Pharma – ADC exposure
Piramal Pharma has capabilities in antibody-drug conjugates (ADCs), high-potency APIs, peptides and complex manufacturing through its CDMO business. Its FY25 annual report shows differentiated offerings contributing 49% of CDMO revenue, with ADC capabilities spanning drug substance and fill-finish.
In Q1 FY27, revenue increased to ₹2,270 crore, with CDMO revenue at ₹1,187 crore and EBITDA at ₹285 crore. The tariff link here is more indirect because Piramal mainly provides development and manufacturing services to other pharmaceutical companies.
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What does this mean for investors?
The U.S. policy is important because it creates a clear difference between generic medicines and high-value specialty products. Indian companies with orphan drugs, fertility products, innovative medicines or ADC capabilities could see opportunities where their specific products qualify for the 0% tariff.
However, the exemption is product-specific, not company-wide. Investors need to look at the individual product’s category, patent status, country of origin and U.S. tariff classification before estimating the actual financial benefit.
