About STASKA Pharmaceuticals

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.

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.

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).