By: IPP Bureau
Last updated : August 17, 2026 7:04 pm
Tapinarof is a topical aryl hydrocarbon receptor agonist and offers a non-steroidal treatment option for patients with the chronic skin condition
Optimus Pharma Private Limited, a subsidiary of Sekhmet Pharmaventures, has become the first company in India to receive permission from the Drugs Controller General of India (DCGI) to manufacture and market Tapinarof Cream 1% w/w and tapinarof bulk drug, marking a significant development in the treatment of plaque psoriasis in the country.
Tapinarof Cream 1% w/w is a non-steroidal topical treatment for plaque psoriasis in adults. Tapinarof is a topical aryl hydrocarbon receptor agonist and offers a non-steroidal treatment option for patients with the chronic skin condition.
Psoriasis affects at least 100 million people globally, according to the World Health Organization. Indian studies have reported psoriasis prevalence ranging from 0.44% to 2.8%, with plaque psoriasis being the most common form. While topical therapies remain an important part of long-term management, treatment options beyond corticosteroids have been relatively limited.
Optimus conducted a clinical study in India involving 213 patients with moderate-to-severe plaque psoriasis. Tapinarof Cream 1% w/w demonstrated statistically significant superiority over placebo in achieving Physician Global Assessment (PGA) success at Week 12.
The study also reported significant improvements over placebo in PASI ≥50 response, percentage reduction in Body Surface Area involvement, Peak Pruritus Numeric Rating Scale (PP-NRS) and Psoriasis Symptom Diary (PSD) scores. Numerical improvements were also observed in higher PASI response rates, including PASI ≥75 and PASI ≥90. Significant improvements were additionally reported in Dermatology Life Quality Index (DLQI) scores.
The formulation was well tolerated among Indian patients, with no immunogenicity concerns identified during the study.
Both Tapinarof Cream 1% w/w and the tapinarof bulk drug are manufactured at facilities operating under cGMP-compliant quality systems. The facilities have undergone inspections by regulatory authorities, including the US Food and Drug Administration and European regulators, and incorporate controls across manufacturing, testing and supply operations to support product quality and patient safety.
By manufacturing both the active pharmaceutical ingredient and finished formulation in-house, Optimus maintains control across the end-to-end manufacturing process, from drug substance to finished dosage form. According to the company, this approach supports consistency, traceability and quality while enabling early commercialisation through strategic partners and improving access for Indian patients.
The approval also highlights Optimus’ capabilities in developing and manufacturing complex and differentiated pharmaceutical formulations.
Sumit Kumar, Chief Commercial Officer, Sekhmet Pharmaventures, said the approval represents a significant milestone for the group and reflects its R&D, regulatory, quality and manufacturing capabilities.
“The approval for Tapinarof Cream 1% w/w and its bulk drug is a significant milestone for Sekhmet and a testament to the strength of our R&D, regulatory, quality and manufacturing capabilities. The group is backed by more than 250 scientists, reinvests over 12 percent of revenue into R&D, and has filed more than 300 patents and secured over 170 grants,” he said.
“Being the first company in India to receive this permission reflects our commitment to bringing differentiated pharmaceutical products to patients while maintaining the highest standards of quality and compliance,” Kumar added.