The story of a commitment
to the quality of every drop
Niki Sam Pharma is a branded group in ophthalmic pharmaceutical products — bringing scientific knowledge, sterile manufacturing and quality control together in one integrated path to build a trustworthy product.
The company, factory and Niki Sam brand
This section gives customers, specialists, business partners and job applicants an overview of the group.
From knowledge to production
Focused on ophthalmic products, Niki Sam Pharma runs formulation design, raw-material sourcing, quality control, manufacturing and distribution within one coherent, trustworthy framework. Full company history, founding year, official capacities and licenses will appear here once approved by management.
Brand identity
Scientific precision, pharmaceutical quality and respect for the patient experience are the three pillars of Niki Sam’s brand identity.
The Niki Sam story — from idea to production line
A closer look at how the factory took shape, the scientific infrastructure behind it, and the culture behind every product.
Niki Sam Pharma: the start of a scientific journey
Niki Sam Pharma was founded with a mission to produce and supply specialized pharmaceutical products and pharmaceutical supplies, drawing on up-to-date technical knowledge, innovation and the pharmaceutical industry's highest quality standards. Its shareholders, managers and specialists, with years of experience in pharmaceuticals and related industries, built a modern, efficient infrastructure for manufacturing in line with FDA requirements and Good Manufacturing Practice (GMP).
The company is the result of combining Niki GmbH's (Germany) international experience in pharmaceutical trade and technology with the production capability and infrastructure of Samen Pharmaceutical in Iran — a combination that designed the company's infrastructure for international standards from day one, rather than adapting to them later.
Focusing on single-dose, sterile ophthalmic drops was a deliberate choice based on a real need in the domestic pharmaceutical market. The company's establishment license was issued by the Ministry of Industry, Mine and Trade on 18 January 2023, followed by a manufacturing license for chemical drugs and pharmaceutical supplies from the Food and Drug Administration on 20 October 2024.
Niki Sam Pharma's production line, with a nominal annual capacity of 150 million eye-drop units, has significant capability to meet the needs of the domestic pharmaceutical market. Research, development and innovation are core drivers of the company's growth, and embedding quality-assurance and quality-control systems throughout every stage of production is a foundational principle of its operations.
Niki Sam Pharma's vision is to become one of the leading, trusted companies in the manufacture of sterile ophthalmic products and pharmaceutical supplies, nationally and regionally — guided by an approach built on quality, innovation, sustainable development and responsibility toward public health.
A production line engineered for precision
The heart of Niki Sam Pharma is a production line designed and commissioned to GMP requirements; cleanrooms, air-handling systems and separate pathways for raw materials and personnel form the base of this infrastructure.
Every formulation passes through multiple rounds of physicochemical and microbial testing in the quality-control lab before entering production — and those tests are repeated periodically throughout the run.
Packaging is designed with the same rigor as the formulation itself; preservative-free and single-use options were chosen specifically to reduce contamination risk and improve ease of use for the patient. Vials are also engineered with a reclosable cap, for safe storage throughout the day after opening.
The technical and engineering team is responsible for preventive maintenance, instrument calibration, and ensuring process stability over time — an approach that prevents quality drift between batches.
Full documentation of every stage, from raw-material receipt to finished-goods storage, enables complete traceability of every production batch — a key tool for accountability and continuous improvement.
The people behind every drop
Behind every Niki Sam package stands a cross-disciplinary team of pharmacists, process engineers, quality-control specialists and technical staff who share one common language: precision.
Continuous workforce training is an inseparable part of the company culture — from GMP induction courses to specialized quality-control workshops, all aimed at maintaining one unified standard.
Niki Sam Pharma works closely with ophthalmologists and clinical pharmacists so that real end-user feedback directly informs the formulation and packaging design of future products.
The company's vision is to expand its product range toward more specialized formulations and a stronger presence in regional markets, without ever stepping back from its current quality standards.
In the end, what defines Niki Sam Pharma is not a single product or machine, but a group of committed people working every day to make every drop produced worthy of a patient’s trust.
The capabilities that build our brand
A general introduction to our units, without disclosing confidential information or proprietary process details.
Production Unit
The Production unit is responsible for manufacturing sterile ophthalmic products using Blow-Fill-Seal (BFS) technology — a fully automated line that forms the container, fills the solution and seals it in one continuous process with no human contact. The line is designed for a nominal annual capacity of 150 million preservative-free, single-dose eye-drop units, which minimises the risk of microbial contamination.
At the heart of the line sits a Rommelag Bottlepack filling machine, which in a single continuous cycle extrudes polyethylene, forms the container, fills it with filtered sterile solution and seals it immediately inside the same sterile enclosure. Downstream are a Rommelag punch and separator, a Bonfiglioli leak detector, a Neri labeller, an Ulma flowpack wrapper, a Marchesini cartoner and a Mettler Toledo checkweigher.
Every batch runs under continuous monitoring of process parameters (temperature, pressure and cycle time) and in line with approved manufacturing instructions. After filling and sealing, product moves through in-process control, labelling and secondary packaging. Throughout, Production works directly with Quality Assurance, Quality Control and Engineering so that each batch conforms to its predefined specification.
Quality Assurance (QA) Unit
The quality management system at Niki Sam Pharma is designed and implemented around GMP requirements, quality risk-management principles and continuous improvement, with the aim of assuring the quality, safety and efficacy of its pharmaceutical products. Through documented processes, effective record-keeping and continuous oversight, it ensures that sourcing, manufacturing, control, storage and distribution all meet legal requirements and quality standards.
Quality Assurance (QA) owns that system and is responsible for its design, implementation, monitoring and continuous improvement — from overseeing GMP compliance and managing documentation to reviewing and approving processes and assessing quality risks. Equipment qualification, calibration and validation run within the same framework, guaranteeing the repeatability, accuracy and reliability of results.
Change control, deviation management and corrective and preventive actions (CAPA) follow a risk-based approach that prevents problems from arising and recurring. Document control, internal audits and the Contamination Control Strategy are applied to prevent microbial, chemical and cross-contamination, so that Niki Sam Pharma products reach the consumer at the highest level of quality and safety.
Quality Control Unit
By studying authoritative pharmacopoeial sources and GMP requirements, the Quality Control unit prepares and maintains specifications, instructions, logbooks and forms related to quality-control testing. Given the limited in-house laboratory capacity, specialized tests are outsourced to laboratories accredited and approved by the Food and Drug Administration. The competence of the receiving laboratory, the test method and how the process is carried out are evaluated; once results are received, the documentation and results are reviewed by Quality Control, and an internal certificate of analysis is prepared.
To keep clean-room and aseptic-production environments within specification, environmental monitoring is carried out routinely on a defined schedule, using methods such as swab sampling, settle plates, air sampling and particle counting under both operating and at-rest conditions. Because the product is aseptically manufactured and sterilized by filtration, the critical filters on the production line are single-use and replaced after every use; filter integrity is checked both before and after each use to confirm the filtration process is performing correctly.
Sterility testing of products is carried out with trained, experienced personnel at the Samen company facility. Water used in manufacturing — one of the essential components of pharmaceutical production — is routinely monitored per pharmacopoeial requirements. Microbial tests, including TAMC and TYMC, and supplementary diagnostic tests where needed, are performed on relevant samples. All results are documented and reviewed within the GMP framework so product quality stays continuously monitored, from raw-material receipt through production to the final product.
Technical & Engineering Unit
Niki Sam Pharma's Technical & Engineering unit works to ensure a stable supply of production infrastructure, keep equipment operationally ready, and support pharmaceutical manufacturing processes. The unit is responsible for planning, operating and maintaining facilities, utilities, HVAC and clean-air systems, purified-water systems, and technical and production equipment.
The unit's activities include planning and executing preventive maintenance, handling corrective repairs, managing calibration, controlling equipment technical records, managing spare parts, analyzing failures, and carrying out development and improvement projects. Working with Production, Quality Assurance, Quality Control, HSE and IT, the unit strives to increase equipment reliability, reduce downtime, maintain required environmental conditions and make optimal use of resources.
Broadly speaking, the unit is divided into two sub-units: 'production-support facilities and infrastructure', which operates and maintains HVAC and clean-air systems, purified water, compressed air, electrical installations and emergency power; and 'maintenance, calibration and management of production equipment', responsible for periodic inspection, preventive servicing, corrective repairs, calibration of measuring instruments, and managing technical records of production equipment — including the BFS filling line.
Research & development
Formulation design and improvement, and transfer of technical know-how to production.
Supply chain
Coordination of raw materials, packaging and supply planning.
Specialist team
Cross-disciplinary collaboration among scientific, operational and technical staff.
Personnel training courses
Continuous staff training is part of Niki Sam Pharma’s quality culture; below is a sample of the specialist courses run for the Production, Quality Control and Engineering teams.
Introduction to filtration processes and pharmaceutical filters
Cleanroom HVAC system design and selection principles
Basic and advanced GMP principles
Equipment qualification and calibration methods
Good Laboratory Practice (GLP)
What sets Niki Sam products apart
The technical standards applied to the design and manufacture of every Niki Sam single-dose eye drop.
Preservative-free
Sterile, free of visible particles
Re-closable vial
BFS (Blow-Fill-Seal) technology
Fully automated production line
Aseptic cleanroom manufacturing
Single-dose product
The principles behind every decision
These values shape our brand voice and the content framework across the entire site.
One group, one shared purpose
This section can host the company's core narrative, introduce specialist teams, share organizational culture and approved staff imagery; final content will be completed with production, QC, engineering and R&D teams.
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