About Krishgen Pudgala LLP | IVD Manufacturer & Distributor | India
About Krishgen Pudgala LLP

The manufacturing arm of the Krishgen Group.

Krishgen Pudgala LLP is the IVD manufacturing entity of the Krishgen Group — set up to bring our ELISA kits to market under full regulatory compliance, alongside distribution for four international diagnostics principals.

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IVD
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TYPICAL ELISA STANDARD CURVEOD vs. CONCENTRATION
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276Products in catalogue
9Disease areas
5Global principals
2021IVD facility established
Who We Are

Built on 20+ years of Krishgen Group diagnostics experience.

Our parent company, Krishgen Biosystems, was established in 2003 as an importer of diagnostic products before expanding into research and food-safety testing — today the official Indian distributor for 70+ international companies.

In 2008, the group began manufacturing ELISA kits for research use only (RUO), now used by pharmaceutical companies, biotechs, CROs, and academic institutions across India and worldwide.

To manufacture for the in-vitro diagnostic (IVD) market specifically — a separate regulatory track from RUO research kits — the group set up Krishgen Pudgala LLP as a dedicated IVD entity, with its own manufacturing facility, quality systems, and product registrations.

Today the catalogue spans 276 products across 9 disease areas, sourced from our own manufacturing plus four international principals. Browse by disease area →  |  Browse by principal →

Made in India

Our ELISA kits are designed and manufactured at our own ISO 13485–certified facility in Bhiwandi, Maharashtra — not white-labelled or contract-manufactured abroad.

2003Krishgen Group founded
70+International principals distributed by the group
10,000 sq ftIVD manufacturing facility — Bhiwandi
Our History

From importer to IVD manufacturer.

2003

Krishgen Biosystems established as an importer of diagnostic products, soon expanding into research reagents.

2008–09

Begins manufacturing ELISA kits for research use, used today by institutes including AIIMS and vaccine developers such as Serum Institute.

2020

Among the first firms to develop ELISA kits for COVID-19, supplied research-use-only pending IVD manufacturing capability.

2021

State-of-the-art IVD manufacturing facility established in Bhiwandi — clean rooms, air handling units, trained manufacturing personnel.

2022

Manufacturing license received for Class B and C IVD products; began marketing our ELISA kits under full regulatory registration.

2026

DIALITE™ CLIA Analyzer and a complete chemiluminescence testing range launched, alongside our existing ELISA menu.

NEWLY LAUNCHED
DIALITE™ CLIA Analyzer

Our own chemiluminescence immunoassay platform.

Fully automated, 120–300 tests/hour, results in under 10 minutes, technology powered by Calbiotech, USA. Built to the same manufacturing standard as the rest of our IVD line.

Walk-away automation 30 sample / 10 reagent positions 8-year product lifetime
What We Offer

Manufactured in-house, or imported from principals we’ve represented for over a decade.

Own Manufacturing

Krishgen Pudgala LLP

  • Manufacturing facility registered with CDSCO
  • CE-IVD registered
  • ISO 13485 certified
  • Krishgen Biosystems RUO range (research use only)
Imported Kits

International Principals

  • LDN – Labor Diagnostika Nord, Germany
  • Generic Assays / Medipan, Germany
  • Virion Diagnostics, Germany
  • MBL, Japan

Why each principal, and what disease areas they cover →

Why Buy Through Krishgen Pudgala

Four things you get regardless of what you’re ordering.

1

Import licenses already in place

We hold the import licenses for every principal we distribute — no waiting on registration before your order can move.

2

Competitive pricing

We’re either the manufacturer or the direct importer — no middleman markup on any line.

3

Ready stock, quick lead times

We hold stock on most SKUs across every disease area and principal.

4

One applications team

Technical support across every product line comes from the same in-house team.

Quality & Certifications

Every product, house-made or imported, meets the same regulatory bar.

ISO 9001 ISO 13485 CDSCO Registered Facility CE-IVD Marked US FDA Facility Registration
Management

Who runs this.

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Nipun Jain

Business Head

Founder of Mercurius Analytica, with a background in logistics. Leads the sales team and channel partners, and brought the marketing, operational, and financial push behind the manufacturing facility. Post-graduate, Indian School of Business.

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Krisha Jain

Technical Head

Bachelor’s in biotechnology, specialising in molecular biology, University of Southern California. Provides technical support and assay development direction, and led the introduction of Olerup HLA SSP-based kits in India.

Trusted By

Working with India’s largest diagnostic chains and hospital networks.

A partial list of organisations that have used Krishgen-manufactured or Krishgen-distributed products.

Where We Are

Registered office in Worli, manufacturing in Bhiwandi.

Registered Office
318/319, Shah & Nahar,
Off Dr. E. Moses Road, Worli,
Mumbai 400018
Tel: 022-4919 8700
Manufacturing Facility
Unit No. 1/2, Om Sainath Complex,
Dapode Village, Bhiwandi
10,000 sq ft · ISO 13485 · CDSCO registered

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