Mumbai,
India | April 20th, 2026 : Rusan Pharma, a leading pharmaceutical
company pioneering pain management, movement disorder, and addiction solutions
worldwide, has achieved a significant global regulatory milestone with the
successful Good Manufacturing Practice (GMP) approvals from Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA). This achievement reinforces
the company’s commitment to world-class quality, compliance, and global
manufacturing excellence.

Rusan
Pharma’s facilities in Ankleshwar (Gujarat) and Dehradun (Uttarakhand) have
successfully secured GMP approval from the PMDA, Japan, one of the most
stringent regulatory authorities globally. The approval covers the company’s
Active Pharmaceutical Ingredient (API) facility in Ankleshwar and its Small
Volume Parenterals (Ampoules) Finished Dosage Formulation (FDF) manufacturing
line in Dehradun.

Commenting
on the achievement, Dr. Kunal Saxena, Managing Director, Rusan Pharma, said,
“I am extremely happy and proud to share that Rusan has been granted GMP
approval from one of the world’s toughest regulatory authorities – Japan’s PMDA
– for our API facility in Ankleshwar, Gujarat, and our Finished Dosage
Formulation (FDF) ampoule manufacturing line in Dehradun, Uttarakhand. This
achievement places Rusan among the very few companies worldwide to have both
API and FDF facilities GMP-approved by the Japanese authority, further
strengthening our position as a trusted partner for high-quality pharmaceutical
development, manufacturing and licensing partner. It reflects the dedication of
our teams, the robustness of our systems, and our unwavering focus on
delivering world-class quality to patients and partners across the globe.”

This
milestone marks a significant step in Rusan Pharma’s global growth journey,
enhancing its ability to cater to highly regulated markets such as Japan while
expanding its portfolio of high-quality pharmaceutical offerings.

Rusan
Pharma continues to invest in strengthening its manufacturing infrastructure,
quality systems, and regulatory preparedness, driven by a long-term vision to
be a trusted global partner in pharmaceutical manufacturing and healthcare
delivery.

About
Rusan Pharma:

Rusan
Pharma Pvt Ltd. is an integrated global pharmaceutical company and market
leader that specialises in the treatment of Addiction and Pain Management. They
offer a complete range of super-specialised products in India and globally.
Rusan indigenously develops, manufactures, and markets novel APIs and finished
formulations and is one of the few notified companies, which is allowed imports
of Narcotic Raw Materials (NRM) such as Thebaine, Oripavine, Codeine and
Morphine for the purpose of manufacturing various APIs and finished formulation
in India and then re-exporting to global markets. Over the years, Rusan has
closely worked with Indian and global institutions such as NACO, UNODC, UNOPS,
Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in
various emerging markets.

Rusan
Pharma’s strength lies in innovation of New Drug Delivery Systems (NDDS) such as
transdermal patches, implants, depot injections. Rusan was the first company to
launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The
company supplies range of products to countries such as India, Canada, Europe,
UK, Russia, CIS, South Africa and other South-East Asian countries. Rusan’s API
and finished formulation manufacturing facilities hold GMP accreditations such
as USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S
(UKRAINE), ANVISA (Brazil) UAE and many more.