Manufacturing
Credentials
Somerset Therapeutics Limited s the first manufacturing company in India for Parenterals to be approved by AFSSAPS (Agence Francaise de Securite’ Sanitaire des Products de Sante’). The company has been USFDA – compliant since 2013 and was most recently audited by the agencyin February 2020 for
general GMPs and pre-approvals.
Business Focus
Somerset Therapeutics Limited provides a comprehensive outsourcing for sterile pharmaceutical products and Opthalmic Solutions, to customers in need of custom pharmaceutical contract manufacturing for US market. From formulation development to commercial manufacturing, Somerset will successfully support your pharmaceutical contract manufacturing of products efficiently and effectively in your efforts to bring products to market. Somerset’s interdisciplinary project team offers innovation, superior quality, and confidentiality.
Somerset’s Quality systems enable us to manufacture quality pharmaceutical products and support the necessary and critical steps to achieving regulatory approval.
Business Advantage
Approved & Certified
Our manufacturing unit has been approved by number of International and National regulatory agencies
Qualified and Experienced
We have well Qualified & Experienced Team for:
- Formulation Development
- Analytical Development
- Technology Transfer
- Contract Manufacturing
- Dossier Preparation
International Presence
We have international presence in the three major global pharmaceutical markets of USA, Singapore and Ukraine.
We also have plans to venture into markets such as Asia Pacific, Latin America and Europe
Approvals
Somerset Therapeutics Limited focuses on manufacturing small volume and large volume parenterals, sterile ophthalmic preparations, and the marketing of pharmaceutical specialties catering to niche segments.
Our state of art manufacturing facility is approved by international regulatory agencies such as:
- US - FDA
- ANSM (French Regulatory)
- TGA (Australian Regulatory)
- Health Canada (Certification)
- Pharmacy & Poison Board, Kenya
- National Agency for Food & Drug Administration & Control (Nigeria)
The Manufacturing Facility has been approved by USFDA and the company has been USFDA-compliant since 2013 and was most recently audited by the agency in February of 2020 for general GMPs and pre-approvals. USFDA has issued a Warning Letter for inadequate reply in respect of two observations made during the Inspection. The Company has taken the necessary steps to address the issues covered in the warning letter and is confident of resolving the same. The Concerns raised are not related to any specific product, data integrity or product quality and the issues covered are more general in terms of technology/facility. The Warning Letter indicates that USFDA may withhold approval of any new drug applications, but the current commercial supplies would be continued with out any disruptions for the already approved products.
Our Clients
Somerset Therapeutics Limited predominantly develops and manufacturing products for
its group entity Somerset Therapeutics LLC, USA.
Somerset Therapeutics also undertakes Contract Development and Contract Manufacturing of Pharmaceutical Products for few other clients which include Navinta LLC, USA, Mylan Laboratories, Ireland, etc.
Somerset Therapeutics believes in adhering to sound business ethics coupled with a management ethos that has very high esteem for its Employees, Shareholders and Customers, imbibing a sense of belief in traditional values, reliance on innovative technology and a strong dependence on modern management concepts.
In doing so, the company constantly strives to uphold the basic management objective and philosophy of our company which stands for “Passion For Quality Care”.
