About Us

API

Micro Labs

Active Pharmaceutical Ingredient

At Micro Labs, we are dedicated in developing top of the line pharmaceutical products while adhering to highest quality norms by well qualified and renowned research team. The continuous strive for perfection has led us to push our standards of manufacturing by building state-of-the-art facilities. Today these state-of-the-art manufacturing facilities and infrastructure facilitate Micro’s Organic Growth in the regulated markets. Our vision to create a Vertically Integrated Organization offering broad spectrum of products with a competitive edge in Global markets has led us to set up of very own API Manufacturing facility.

Micro Labs API Unit is built over an area of 24000 square meters with world class manufacturing facility. GMP-compliant requirements have been strictly followed in the construction of the API manufacturing unit. A total strength of 280 employees ply their trade at the API manufacturing unit including a technical & scientific staff of ~200 employees that comprises of engineers, pharmacists, science graduates and other technical staff.

"API Unit is a backbone of any Pharmaceutical Industry to provide quality & affordable medicine to mankind. We produce APIs with environment friendly chemistry and non-infringing innovative processes."

API unit facilitates the robust production of APIs in therapeutic areas such as anti-hypertensive, diuretic, anti- malarial, anti-diabetic, ARV, anti-inflammatory, and ophthalmology. A full-fledge pilot plant supports the scale-up activity of all new developments. Plant is designed to handle cryogenic, high temperature and high pressure reactions. The Commercial, Pilot Plant and Kilo Lab is equipped with finishing area that meets modern day production standards. The Company’s Quality Management System is designed to meet the CGMP requirements as per ICH Q7 and EUCGMP Part II guideline and US21CFR 210, 211. The site has been accredited by international pharma regulatory agencies like USFDA, EDQM, ANSM & TGA, etc.

We are aiming to increase our Global presence in API markets focused by Research based product development. To encourage & support the innovation in Micro Labs; API unit boasts strong Research & Development Centre (DSIR Approved) nurtured by research team of 150 scientists that comprises of engineers, science graduates, recipients of prestigious Doctorates from premier institutes / universities. R&D centre is a star addition to the company’s glittering profile. The state-of-the-art-R&D Centre equipped with advance cutting edge analytical instruments like High field NMR (FT-400MHz), ICP-MS, LCMS-Ion Trap, P-XRD, Ion Chromatography, FTIR, GCMS, GCHS, UPLC, HPLC, Flash Chromatography, Lyophilizer, Preparative LC, DSC, TGA & many more. For Micro Labs, the API R&D Centre is a strategic addition in our foray towards a global arena. An impressive R&D Centre with Kilo level Scale-up Lab facility is one of the key features of the unit, which enables to develop high value and low volume APIs. The modern facilities are a perfect complement to the talent of our product development team. The research team can express their true potential, which in turn helps Micro Labs to cater its products for the global market.

The R&D division and Kilo Lab facility of the API manufacturing unit devotes all its energies and is constantly engaged with the exploration and development of API’s & NICHE molecules with multi-step Chemical synthesis. Key focus areas include

(a) Development of Innovative & non-infringing routes for API’s of global standard

(b) Creating core competency in select therapeutic segments involving innovative chemistry

The API R&D Centre has developed strong skills in identification of non-infringing routes supported with IPR [Intellectual Property Rights] cell thereby creating an ‘IP capital’ for the company.

This unit has been envisaged to provide a competitive advantage for our international business efforts by providing strategic APIs involving the economical & environmental friendly processes.

The Unit has been carefully designed and further strengthened by means of procedures and practices to remain compliant with applicable statutory requirements. The site is accredited with ISO 14001 and OHSAS 18001.

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.