Rusan Pharma’s API Plant in Ankleshwar, Receives US FDA GMP Approval

Rusan Pharma’s API Plant in Ankleshwar, Receives US FDA GMP Approval

By, Admin 24 July 2024

Overview

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 (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.
 
Rusan Pharma Portfolio Expansion

  • 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.

 Words from MD: Rusan Pharma

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.”
 
FDA Approval of Ankleshwar Facility

  • The US FDA 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.

 GMP Approval for Ankleshwar Facility

  • 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.

 
Rusan Pharma: Market Presence

  • 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.
     

Rusan Pharma

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. Saxena.


 Rusan’s Ankleshwar Manufacturing Unit

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.


 2nd Manufacturing Facility

  • 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.

 
Rusan Pharma Pvt Ltd.

  • Rusan Pharma Pvt Ltd. is an integrated global pharmaceutical company and market leader that specializes in the treatment of addiction and pain management. 
  • The company offer a complete range of super-specialized products in India and globally.

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