About Us

R&D

Micro Labs has a long term commitment to developing Bio – equivalent Generics with the help of world class research and high quality standards. Our research and development team consists of over 200 scientists and developers who are highly qualified and experienced in formulation and analytical development. Our focus remains on continuing to develop new formulations in various dosage forms including Solid dosage, liquid dosage, Sterile preparations, injectables, Creams, ointments etc.,.

 

The highlights of the R&D centres at Micro Labs include:
  •  

    Development of Generics

  •  

    Strict Compliance IPR / Non-infringing route

  •  

    Infrastructure includes facility for scale-up & validation

  •  

    Capability includes handling complex chemistries

  •  

    Regulatory complaint development & scale-up

  •  

    File EU-DMF / E-COS / US-DMF

  •  

    8 Molecules under development

The dosage forms and technologies developed by our R&D include:
  •  

    Immediate Release Solid Dosage Form (IR)

  •  

    Sustained Release tablet Technology (DR)

  •  

    Effervescent Technology

  •  

    Enteric Coated Technology

  •  

    Direct Compression Technology

  •  

    Oro dispersible tablet form

  •  

    Chewable tablet form

  •  

    Hot melt extrusion technology

  •  

    Tablet in capsule technology

Once a pharmaceutical product is developed, it undergoes the following:
  •  

    Conceiving and identifying product profile

  •  

    Pre formulation studies

  •  

    Lab formula development and development for stability & validation

  •  

    Scale up for process optimization /validation

  •  

    Analytical method development

  •  

    Pilot scale mfg in cGMP facility (Clinical supplies)

  •  

    Stability studies as per ICH guidelines

  •  

    Dossier preparation for submission/Technical assistance for contract manufacturing

  •  

    Data management (for transfer to customer/ regulatory Affairs)

ADVICE ABOUT REPORTING

  • Report adverse experiences with medications
  • Report serious adverse reactions. A reaction is serious when the patient outcome is:
    • Death
    • Life-threatening (real risk of dying)
    • Hospitalization (initial or prolonged)
    • Disability (significant, persistent or permanent)
    • Congenital anomaly
    • Required intervention to prevent permanent impairment or damage
  • Report even if:
    • You’re not certain the product caused adverse reaction
    • You don’t have all the details however point nos. 1, 5, 7, 8, 11, 15, 16 & 18 (see reverse) are essentially required.
  • Who can report:
    • Any health care professional (Doctors including Dentists, Nurses and Pharmacists).
  • Where to report:
    • After completing, please return this form to Micro Labs Ltd, Pharmacovigilance Cell
  • What happens to the submitted information:
    • Information provided in this form is handled in strict confidence. PV cell at Micro Labs will carry out causality analysis and the data is statistically analysed and finally submitted to CDSCO.

Confidentiality:

The patient’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the reporter’s identity in response to a request from the public. Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.