Ankleshwar, India : RUSAN
PHARMA PRIVATE LIMITED, a pharmaceutical
company based in India specializing in the area of addiction treatment and pain
management, recently announced that the United States Food and Drug
Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval
for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat,
India). The approval, received on May 29, 2024, followed a comprehensive
five-day on-site inspection conducted from April 29 to May 3, 2024.
This milestone marks a significant achievement
for the company as it paves the way for it to enter the US API market. With an
active US Drug Master File (DMF) for niche APIs like Eflornithine Hydrochloride
Monohydrate and Nalmefene Hydrochloride, Rusan Pharma plans to expand its
portfolio with additional APIs, including Apomorphine, Buprenorphine, Naloxone,
Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam,
Oxazepam, and Temazepam.
Speaking on the achievement, Dr. Kunal Saxena,
Managing Director of Rusan Pharma,
highlights, "This GMP approval by the USFDA underscores our unwavering
commitment to maintaining the highest standards of quality and manufacturing
excellence, expanding our global presence and credibility. This achievement
instils confidence in our partners and clients, reassuring them of our
dedication to excellence in producing high-quality APIs that meet the most
stringent global standards.”
The USFDA approval of the Ankleshwar facility
is a critical development in Rusan Pharma's strategy to become a key player in
the global pharmaceutical industry. Currently, the company supplies APIs to
various US-based companies focused on orphan drugs, addiction treatment, and
obesity medications. The approval will further enhance Rusan's capabilities,
expand its API product portfolio, and increase its footprint in the growing US
pharmaceutical sector.
Following on-site audits, Rusan’s API facility
in Ankleshwar is GMP approved by other stringent international agencies such as
Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan implemented
21-CFR-compliant software solutions like SAP, Laboratory Information Management
System (LIMS), document & quality management systems (DMS & QMS) and
electronic logbooks, ensuring a move towards paperless manufacturing. This
transition, along with comprehensive staff training and monitoring, posed
significant challenges that the company successfully overcame.
Before receiving this approval, Rusan Pharma
established a robust presence in key markets such as Australia, Brazil, Canada,
EU, Mexico, New Zealand, and the United Kingdom. The USFDA's endorsement
enables the company to market its APIs to US clients with existing marketing
authorizations and those developing new formulations. This approval further
bolsters our customers' and regulatory agencies' trust and confidence in us
globally.
"Our vision is to be a one-stop solution
provider in the niche category of addiction treatment and pain management.
Integration with API enables us to remain competitive, while promoting our
finished formulation in the global market. It also enables us to be independent
from other companies for the supply of critical APIs for manufacturing of
various finished formulations, especially for narcotic and psychotropic
products. Timely delivery of quality medicine is key to any pharmaceutical
business. Hence, a robust supply of API enables us to achieve a rapid time to
market with critical products" adds Dr
Kunal Saxena.
Rusan’s Ankleshwar manufacturing unit’s
strategic role in its manufacturing and distribution network is underscored by
its focus on critical APIs like fentanyl and buprenorphine. The company's
vision is to be a comprehensive addiction treatment and pain management
provider, ensuring competitive and timely delivery of quality medicines.
In November 2023, Rusan Pharma inaugurated its
second API manufacturing facility in Pithampur SEZ (Madhya Pradesh, India) with
an annual production capacity of upto 400 MT, which is significantly higher
than the Ankleshwar plant. By mid-2025, the company plans to seek GMP
inspection of this new facility by the US FDA and other international
inspecting agencies. This expansion aims to boost Rusan's manufacturing
capabilities.
About Rusan Pharma:
Rusan Pharma Pvt. Ltd. is an integrated global pharmaceutical company
and market leader that specializes in the treatment of Addiction and Pain
Management. They offer a complete range of super-specialized 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 US FDA, Health Canada,
EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA
(Brazil) UAE and many more.
For more information please visit https://www.rusanpharma.com/
https://in.linkedin.com/company/rusan-pharma-ltd-b97178201
Contact
Details:
Rusan
Pharma Pvt. Ltd.
Pramod
Yadav
Mob: 98927
16899