HGHEURO.COM - Spectrum Pharma


Spectrum Pharma is a specialized pharmaceutical company engaged in the development, production and marketing of quality finished dosages and active pharmaceutical ingredients (APIs), which are the main raw materials for the pharmaceutical industry.

Spectrum Pharma was founded on August 21, 2009.

Our commitment to quality in everything we do is uncompromising and covers all stages of the development, production and marketing of our medicines: from the supply of materials to production. Our facilities are among the most advanced testing facilities to guarantee the quality of our products in accordance with WHO cGMP guidelines. The equipment is tested and certified, and each production process is tested.All supplier procedures are strictly controlled to ensure that only the highest quality materials are used in our products. All products are manufactured with appropriate quality, reliability and safety for the purposes for which they are intended.


We believe that the key to strengthening the foundation of a responsible brand is to consistently achieve high quality standards in everything we do. Quality is introduced at all stages of our activities, including procurement, production, delivery and safe disposal of products. Over the past few years, we have focused on improving our quality management systems to meet and exceed current expectations of regulatory authorities such as CDSCO, USA FDA, MHRA, TGA, MCC, WHO, etc.


We strive to achieve a zero level. create defects and carry out strict quality control to ensure that every product released from its factory complies with all applicable quality standards and regulations. This reputation as a supplier of consistently high-quality products has helped us become one of the key partners for multinational governmental and non-governmental institutions worldwide. We regularly conduct supplier audits to ensure compliance with relevant quality standards throughout the value chain. The Quality by Design (QbD) team and the Quality Assurance Development Group (DQA) work closely with the R&D function for quality control.


We understand that adequate and timely investment in strengthening our quality management protocols promise long-term benefits in terms of eliminating cost of failure, enhancing stakeholder confidence and bolstering legal compliance.

Our facilities ensure quality through constant upgradation of equipment, adoption of technological advances and implementation of industry benchmarked practices. We have developed a robust system to manufacture products that adhere to stringent specifications & in-process controls subsequently leading to high product quality.

Glass ampoules have been widely used for drugs. Anesthesiologists, along with nurses and nurse aides, represent a significant proportion of the group of professionals that routinely manipulate this material. Glass is made of basically three inorganic compounds (SiO2 – 73%; Na2CO3 – 14%; CaCO3 – 11%). In essence, it is colorless. During its manufacture metallic oxides (iron, cobalt, manganese, nickel, aluminum, chrome, arsenic, barium, and others) are added. Many of these metallic oxides can give color to glass. Glass has important characteristics that are responsible for its wide use in the manufacture of containers for drug and other sterile substances. We purge our ampoules with nitrogen prior to filling in order to clean out area, and ampoule filling machine outputs 80000 ampoules per  working day. Our ampoule filling machine hermetically seals glass ampoules from Germany to prevent any glass shards or other outside contaminates from getting into our products. Also we add on top nitrogen gas into each of the ampoules and immediately seal the tip of the ampoule using the flames of the 12th jet ampoule sealer to make active ingredient be stable for many years and avoid any oxygenation and destruction.

Our TopLine include:

  • Production in cGMP environment

  • Statistical in-process control

  • Regulation system for ISO specific stem diameter

  • 100 % inspection of key dimensional characteristics

  • 100 % camera inspection of break systems (OPC, CBR, SCO)

  • Quality level according to ISO for Type B, C and D

  • Reduced stem diameter tolerance for superior processing

  • Optimized dimensions for better processability, e.g. reduction of tolerances


A broad range of glass vials, quality levels and controlled surface chemistry enable us to tailor the primary packaging solution to your specific needs. All Spectrum Pharma Vials are manufactured and packed in environmentally controlled areas certified by ISO 9001 and ISO 15378 and comply with PH.Eur., USP and JP international standards.

Our Top Line include:

  • Production in cGMP environment

  • Statistical in-process control

  • Available blowback geometries: NBB, EBB and ABB

  • Dimensional and pharma AQL levels according to ISO

  • 100 % camera inspection of dimensional parameters and critical cosmetic defects

  • Advanced glass surface treatment e. g. functional coatings and delamination controlled-surfaces

  • Available as sterile and nested packaging configurations


 

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