Rusan Pharma’s API Plant in Ankleshwar (India) Receives USFDA GMP Approval
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 (US FDA) 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 US FDA
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 US FDA approval of the Ankleshwar plant 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.
Rusan’s API facility in Ankleshwar is GMP approved,
following on-site audits 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), 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 US FDA'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 the end of 2024, the company plans to seek GMP inspection of
this new facility by the US FDA and other international agencies. This expansion
aims to boost Rusan's manufacturing capabilities.
For more information, please visit www.rusanpharma.com
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