STASKA Pharmaceuticals is an outsourcing facility offering fully customized sterile and non-sterile products to a variety of healthcare providers and offices. As the only FDA registered 503B outsourcing facility in Nebraska, STASKA prides itself on transparency, accessibility, and technical expertise. Through the uncompromised quality of its products and services, STASKA is dedicated to enhancing pharmaceutical supply for patients and providers.
Lyndon Leitner is STASKA’s owner and operator. An industry professional with 20 years of pharmaceutical experience, Dr. Leitner owned and operated National Pharmacy in Lincoln, Nebraska, for a decade. He was also a Pharmacy Manager for Lincoln Neighborhood Pharmacies, and as Pharmacy District Manager for Kmart Pharmacies, Dr. Leitner oversaw all operations for 31 pharmacies in Eastern Nebraska, Southern Wyoming, all of Colorado, and Northern New Mexico. He holds a Doctor of Pharmacy degree from the University of Nebraska Medical Center, and brings a wealth of knowledge to the Company. Already a proven business owner and operator, Dr. Leitner will steer STASKA to great success.
Bala Kondepu joined in August 2020 as Director of Quality. Bala holds a Masters in Organic Chemistry. He has extensive experience in both the brand and generic pharmaceutical industry which includes roles in microbiology, sterilization, quality control / Assurance, validation and manufacturing. He has over 15 years of experience in the Pharmaceutical industry which includes solid dose, topical, ophthalmic and sterile injectables and product manufacture. Prior to STASKA Pharmaceuticals, He worked several years at NATCO PHARMA and MEDREICH managing QA, validation and commercial as well as R&D and stability programs.
Foster an environment of creativity to transform new ideas into breakthrough services and solutions.
State-of-the-art labs, equipment, technology, and expertise to ensure each product is developed with uncompromised quality.
Robust, science-based risk and gap analysis to develop products with improved outcomes.
Our processes and procedures stem from one common goal – keeping your patients’ safety a top priority at all times.
High quality and affordable products that make a difference in patient lives, and meet the needs of the healthcare providers that treat them.
We bring a positive attitude, collaborative mindset, and patient-focused approach to each of our partnerships.
STASKA Pharmaceuticals is equipped with state-of-the-art labs, equipment, and technology to ensure each product is developed with uncompromised quality. All processes and procedures are documented and executed with precision. Our proven technologies, high-quality products, and broad expertise consistently deliver you and your patients the best value. Schedule a consultation with STASKA to discuss your custom product today.
Facility Details
If there is one attribute to which we attach the utmost importance it is quality. Quality is considered paramount at all locations where we conduct regulated research, development, manufacture, testing and distribution of products.
Our focus on quality helps ensure product safety and efficacy, regardless of the drug form. This is only possible with an extremely high degree of teamwork through the company-with a common goal of quality and patient safety.
We establish uniform standards for all products, we believe meeting pharmacopeia requirements is minimum standards. Our policy of continuous process and product improvement drives us to work toward exceeding these minimum standards.
Consistency is rarely an accident. Rather, it is the result of a well-conceived, rigorously implemented quality Management System (QMS). Our QMS focuses on continual improvement aimed at optimizing processes and eliminating non-value-adding efforts in production. These efforts are primarily directed towards reducing variability in process and product quality characteristics.
To achieve this, we follow a three -step process:
Our unwavering commitment to quality goes beyond ourselves. We insist that our business partners comply with state and national (FDA) regulations.
During the manufacturing process, the quality control (QC) team establishes and implements robust practices to ensure quality. Post manufacturing is reinforced through the safe destruction of defective and expired products.
We have successfully overcome challenges such as growing regulatory pressures, demanding compliance requirements and stringent quality standards as a result of our robust quality control systems. The company functions on a business model with a futuristic outlook that envisions the anticipated regulatory developments. This prepares us to adapt readily to the changing environment and ensure business continuity.
We have In-house testing facility for chemical (potency & impurities) as well as microbiology (BET and MLT).