Rusan Pharma’s API Plant in Ankleshwar Receives (India) USFDA GMP Approval
July 22 2024 - 1:30AM
Business Wire
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 press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240718239433/en/
Rusan Pharma's API facility in
Ankleshwar, Gujarat, India (Photo: Business Wire)
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.
About RUSAN PHARMA PRIVATE LIMITED:
RUSAN PHARMA PRIVATE LIMITED is an integrated global
pharmaceutical company and market leader that specializes in the
treatment of Addiction and Pain Management. Their strength lies in
innovation of New Drug Delivery Systems such as transdermal
patches, implants, depot injections. 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) for the purpose of manufacturing
various APIs and finished formulation in India and then
re-exporting to global markets. Rusan has 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 was the first company to launch
Fentanyl, Buprenorphine and Nicotine Transdermal Patches in
India.
For more information visit www.rusanpharma.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240718239433/en/
Pramod Yadav: 9892716899, pramod.yadav@rusanpharma.com