About STASKA Pharmaceuticals

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.

Quality Pharmaceutical Products Available Across the US.

STASKA Licensing Map

Our Leadership

Lyn Leitner, Pharm D - CEO

lyn leitner pharmD CEOLyndon 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.

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Meaningful Innovation

Foster an environment of creativity to transform new ideas into breakthrough services and solutions.

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High Operational Performance

State-of-the-art labs, equipment, technology, and expertise to ensure each product is developed with uncompromised quality.

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Improved Outcomes

Robust, science-based risk and gap analysis to develop products with improved outcomes.

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Safety & Transparency

Our processes and procedures stem from one common goal – keeping your patients’ safety a top priority at all times.

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Time. Cost. Convenience.

High quality and affordable products that make a difference in patient lives, and meet the needs of the healthcare providers that treat them.

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Winning Spirit

We bring a positive attitude, collaborative mindset, and patient-focused approach to each of our partnerships.

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The STASKA Pharmaceutical Facility

staska pharmaceutical building


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

  • 7,300 sq ft total
  • 3,000 sq ft cleanroom suite 
  • 1,200 sq ft ISO 7 room
  • 4 ISO 5 laminar flow hoods
  • cGMP Certified
  • FDA registered 503B outsourcing facility
Quality Assurance Department

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:

  1. Be right the first time. Identify and eliminate defects, improve efficiency.
  2. Under take “Risk-Based” approach to manufacturing and mitigate risks wherever they are likely to impact quality.
  3. Develop transparency in all areas of operations and build robust quality culture across the organization.

Our unwavering commitment to quality goes beyond ourselves. We insist that our business partners comply with state and national (FDA) regulations.

Quality Control Department

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 an in-house testing facility for chemical (potency & impurities) as well as microbiology (BET and MLT).