Sterin Labs Private Limited
Sterin is a development-driven organization with a proven track record of delivering high-quality drug products to global regulated markets. With expertise in complex NCE drug product development, Sterin guides products from portfolio management, early screening, drug product development, technology transfer, manufacturing of registration batches at USFDA/EU-approved facilities, and extends support towards regulatory approval.
Sterin has successfully executed drug product technology transfers for highly complex sterile drug products, including injectable solutions, suspensions, emulsions, lyophilized, pre-filled syringes, RTU bags, ophthalmic gels, and controlled substances, across the United States and the European Union. Skilled in handling cytotoxic compounds and hormones apart from general category drugs for non-oral dosage forms, Sterin ensures safety and compliance. Certified under ISO 9001, ISO 2700, and Sterin stands for quality and regulatory excellence.
Our Services
Formulation
Development
Formulation development is a process of utmost importance as it involves developing an adequate preparation and form of a drug, which is both stable and acceptable to the patient.
Analytical Method
Development
The purpose ofanalytical method development is to establish the identity, purity, physical characteristics, and potency of drugs, including the drug’s bioavailability and stability.
Scale Up/Technology
Transfer
It is the process by which a developer of technology makes its technology available to a commercial partner that will exploit the technology.
R&D Stability
Services
Stability testing is a measurement to assure that the drug substance or product is able to maintain its overall quality.
Who we are
- Group of experts joins hands together from each function to create a Development center for Parenteral dosage form (Liquids, Lyophilized, Liposomal, Suspension, and Emulsion), Topical dosage form, Ophthalmic dosage form and Nasal dosage form.
- Our Experts are having greater technical skills in end-to-end product development for regulated market registration.
- Our Expertise joins us in formulation development, analytical method development, and intellectual property and brings with us more than 17 years of rich experience in all areas.
- Prior to joining us, our experts were working with leading pharmaceutical organizations like Dr. Reddys Laboratories, Hyderabad, and Sun Pharma Vadodara, holding increasing responsibilities.
- Our experience has been mainly in the area of sterile dosage form development, including lyophilized products, complex depot injectables, peptide-based formulations (small and larger molecular weight), Ophthalmic suspension, Nasal drops, and Topical formulations.
- Our team has significant experience in process characterization and scale-up as well.
- Our team has not only worked on generic product development but has also developed several NCEs (at various phases of development) and 505(b)(2)s.
- Our experts have worked with clients globally, including several top-tier generic and innovator pharmaceutical organizations.
