Wintac is the first manufacturing company in India for Parenterals to be approved by AFSSAPS (Agence Francaise de Se’curite’ 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.
Wintac 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, Wintac will successfully support your pharmaceutical contract manufacturing of products efficiently and effectively in your efforts to bring products to market. Wintac’s interdisciplinary project team offers innovation, superior quality, and confidentiality.
Wintac’s Quality systems enable us to manufacture quality pharmaceutical products and support the necessary and critical steps to achieving regulatory approval.
Wintac 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:
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.
Wintac predominantly develops and manufacturing products for
its group entity Somerset Therapeutics LLC, USA.
Wintac also undertakes Contract Development and Contract Manufacturing of Pharmaceutical Products for few other clients which include Navinta LLC, USA, Mylan Laboratories, Ireland, etc.
Wintac 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”.