The clinical research services of Teva Pharmaceuticals  in India offers services that spans from conducting Bioavailability/ Bioequivalence (BA/BE), clinical end-point studies  and other affiliated services that include Medical Writing, Clinical Data Management, Biostatistics and Central Laboratory services. With 370+ skilled personnel, the team is spread between three facilities that are strategically located in Bangalore and in Mumbai.

The unit in Mumbai is Watson Pharma Private Limited (WPPL) and the Bangalore unit is Lotus Labs Limited (Lotus). WPPL is a dedicated facility for Teva, while Lotus serves Teva and non-Teva clientele.

The following are some of the credentials of both the units combined:

  • Year of Inception:
    • Lotus Laboratories Private Limited: 2001
    • Watson Pharma Private Limited: 2006
  • Capability:
    • Lotus: Any type of SOD, Inhalers, nasal sprays, Injectable, transdermal patches, topicals and suspension.
    • WPPL: SOD including controlled substance, suspension, injectable.
  • Bioavailability / Bioequivalence (BA/BE) Studies capability:
    • Lotus: Conducted 2600+ pivotal studies. Dossiers submitted to over 45 countries worldwide.
    • WPPL: Conducted over 1100 BA/BE studies.
  • No. of regulatory inspections:
    • Lotus has successfully cleared 89 regulatory inspections since inception (until Feb 2020). This includes 26 USFDA, 12 WHO, 3 UKMHRA, 6 EU group and 10 ANVISA inspections. “Zero observations” in the last five USFDA inspections.
  • WPPL: 17 inspections that include 8 USFDA, 2 UKMHRA and 3 ANVISA inspections.

  • No. of Beds in clinics:
    • Lotus: Has two Clinics with 74 beds in the Vasanthnagar clinic and 120 beds in the Jakkur clinic.
    • WPPL: Clinic with 144 beds at Seawoods facility in Navi Mumbai.
  • Bioanalytical capabilities: Lotus and WPPL have distinct Bioanalytical units. The combined Bioanalytical capabilities are:
    • of Bioanalytical methods that is in our repository: 800 plus
    • of samples that can be analyzed in a month: 78000 per month
    • Have the ability to analyse compounds at low sensitivity levels of about 0.1 pcg / mL, can measure free fraction, unbound drugs, metabolites etc.
  • Clinical End-point study capability (Lotus):
    • Conducted ten studies across India for USFDA/EU submissions in different therapeutic areas like Oncology, Dermatology, Ophthalmic, CNS drugs and gastrointestinal drugs.
    • 5500+ patients have been enrolled across studies conducted in India.
    • For patient based studies, the clinical trial sites managed by Lotus Labs were inspected by USFDA (25 inspections completed as on Feb 2020). The last four USFDA inspections were successfully cleared without any observations.
  • Central Laboratory (Medical Diagnostic Laboratory):
    • Lotus Central Lab: CAP certified since 2008 and NABL accreditated since 2006. The Labs is ISO 15189-2012.
    • WPPL Central Lab: CAP certified since 2019.
  • Medical Writing:The medical writing services offered by Lotus includes Clinical Study reports (CSR), Protocols, Study supportive modules, Manuscripts, Medical Coding (MedDRA & WHO Drug) and eCTD submissions for different regulatory agencies.
  • Clinical Data Management (CDM):
    • The team provides end-to-end CDM support from Start-up activities, study conduct until Database lock for all Phases of the studies.
      • Database programing performed using Inform and Medidata Rave. All Programming activities performed in-house.
      • The Database developed by CDM team are CDISC compliant.
      • Medidata Rave Certified Programmers.
      • Medical Coding: Use of latest WHO-DD and MeDRA dictionaries.
  • Biostatistics:
    • The Biostatistics team works from both Bangalore and Mumbai locations.
    • The team works on the BA/BE, PK and Statistical analysis.
    • Development of Statistical Analysis Plans and Mock shells.
    • Performs the Statistical review on all Tables, Listings and Figures generated by SAS programming team for all phases of the studies.

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