MEDCELL PHARMA PRODUCTION – QUALITY FIRST

We employ a Quality by design (QbD) approach towards developing our innovative patented pharma and nutraceutical products. Our scientists and R&D team maintain the statistical, analytical and risk-management methodologies required to develop and manufacture world-class medicines.

We maintain complete transparency in every aspect of our production – from sourcing to the final dispatch of goods throughout the supply chain – which ultimately results in the supreme quality of all Medcell Pharma products.

Quality by Design

Our Quality by Design (QbD) is practised in a way that every product meets the required parameters of performance profile [Target Product Profile (TPP), Target Product Quality Profile (TPQP)] and critical quality attributed (CQA).

Our quality system offers the pharmaceutical product with increased self-regulated flexibility while maintaining tight quality standards and real-time release of the drug product. Each action is taken to deliver products with exceptional grades to address the needs of patients.

Quality par Excellence

Our highly qualified Quality Management team ensures that each of our products qualifies as per global standards of purity, efficacy and safety.

Our Q&A Team ensures the implementation of the latest updated ICH guidelines from time to time as and when required to maintain Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

Our manufacturing sites are regularly audited by CQA and outside authorities to ensure 24×7 compliance and conformance. In addition, our quality management team is also involved in overseeing compliance concerning Good Clinical Practices and Good Laboratory Practices.

STATE-OF-THE-ART FACILITIES: US FDA APPROVED, WHO GMP & EU GMP CERTIFIED

Our facilities have received approval from various prominent international authorities. Our Plant is accredited by WHO-GMP & EU-GMP with advanced analytical labs. Our products are manufactured in state-of-the-art manufacturing facilities that comply with major global regulatory agencies like UK-MHRA, US-FDA & ICH guidelines. Our Plants are Audited and approved by MOH of around 35 countries and Registered with Medical Evaluation Board (Dutch Authority) and the European Medical Agency (EMA) as EUGMP approved Manufacturer.

Medcell pharma production - who gmp certified
Medcell pharma production - mhra approved
Medcell pharma production - us fda approved
Medcell pharma production - ich guidelines

COMPLIANCE WITH ICH GUIDELINES: DOSSIERS

Our highly skilled in-house Regulatory team is backed by our robust Quality Assurance and Analytical departments as they swiftly submit dossiers as per eCTD/ACTD and ICH guidelines. Our objective is to ensure smooth and qualitative submission of dossiers to the respective MOH within the expedited timelines. Our team of experts have the superior industry knowledge and background in handling regulatory queries from both the respective authorities and end customers.

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MEDCELL PHARMA PRODUCTION WITH PATENTED TECHNOLOGY

In Medcell, our products are manufactured in a state-of-the-art facility with cutting-edge patented technology. The usage of innovative & patented technology in our product range amplifies the value of the existing formulation and makes the existing molecules more therapeutic, effective and valuable. Our unique technology also helps us to provide eco-friendly solutions in product formulations. Below are a few innovative technologies applied in our product formulation:

Thinoral™ Technology

  • Used for fast-dissolving oral thin film- It makes it easier and more convenient to deliver drugs to patients, especially those who face problems with other dosage forms like tablets, capsules etc.
  • Superior efficacy, bioavailability & better results in patients.

Microbac™ Technology

  • Used for probiotics range of products.
  • Microencapsulation – A process by which small particles are surrounded by a coating to produce microcapsules in the micrometre range
  • Microbac™ technology protects against:
    i. Environmental factors – Humidity, temperature and light
    ii. Bodily factors – Gastric acidity, bile salts, degradative enzymes
  • Protects L. rhamnosus GG (ATCC 53103) and keeps them alive throughout shelf life
  • Ensures higher survival and biological activity