Custom OEM & Contract Manufacturing

Turnkey IVD Manufacturing & Private Labeling Solutions

What is OEM at Alpine Biomedicals?

OEM (Original Equipment Manufacturer) partnership enables healthcare brands, distributors and global diagnostic companies to utilize our certified manufacturing infrastructure to manufacture customized rapid diagnostic kits under the respective brand. Our OEM program's primary focus is to maintain international quality standards and world-class technical expertise while providing safe, highly reliable diagnostic products to meet strict regulatory benchmarks.

What is OEM at Alpine Biomedicals?

Our OEM and contract manufacturing services are built on international standards and help our partners worldwide throughout the product development lifecycle. All of this is produced in our CDSCO registered, ISO 13485 certified and GMP approved facility including custom conjugate formulations, buffer optimisation, bulk uncut sheet manufacture, high speed automated assembly, custom pack sizing and private label packaging.

From small batch custom assay development to high volume commercial production, our solutions are cost-effective and scalable with complete technical support and world-wide export documentation.

Step-by-Step OEM Workflow

STEP 1
Requirement & NDA
STEP 2
R&D
Formulation
STEP 3
Batch
Validation
STEP 4
Custom Packaging
STEP 5
Commercial Dispatch

Core OEM Business Models

Flexible engagement options to suit your supply chain, from bulk raw material to packaged products ready for sale.

Service Model Deliverables Ideal For
Private Labeling Branded boxes, pouches, & cassettes. Ready-to-sell consumer products.
Bulk Uncut Sheets Lateral flow membranes & pads. Overseas cutting & assembly.
Bulk Reagents Custom biochemistry liquids & buffers. Labs & analyzer distributors.
Contract Manufacturing Full custom formulation & production. Scaled ISO-certified outsourcing.

Comprehensive Rapid Diagnostic Assay Portfolio

We design, formulate and manufacture full OEM products in all major medical verticals:

12+

Years of experience

Our Core Values

Core values that shape every experiment

Scientific integrity

We adhere to the highest standards of honesty and transparency in every phase of our research.

Innovation-First Mindset

We adhere to the highest standards of honesty and transparency in every phase of our research.

What We Do

Transforming scientific questions into real-world results

At our core, we are dedicated to advancing scientific understanding through purposeful research tailored to address today's most pressing challenges.

98%

Environmental Science

Our lab delivers data-driven insights that help protect natural.

Comprehensive Laboratory Testing

We offer advanced testing services across a wide range of scientific disciplines, delivering accurate, validated results for research.

Research Design & Methodology

From hypothesis to execution, we craft tailored research strategies that align with scientific best practices and your project goals.

Data Analysis & Interpretation

Our team translates complex datasets into clear, actionable insights — helping you make informed decisions backed by clarity.

Collaborative Scientific Partnerships

We work closely with academic institutions, private industries, and government agencies to co-develop innovative research.

Built for Scale

Infrastructure & Cleanroom Capabilities

Our specially-designed manufacturing facility in Saha (Ambala, India) offers an end-to-end manufacturing platform for the production of rapid diagnostic test kits:

GMP-Approved Cleanroom Standard

Class 100,000 (ISO 8) environment with Climate Control and very low Humidity ($<30\%$ RH) for maximum membrane stability and shelf life.

In-House R&D & QA Laboratories

State-of-the-art testing and quality assurance laboratories for consistent lot-to-lot performance, antibody density optimization and custom assay development.

1.5+ Million Monthly Capacity

Scaled manufacturing lines to produce more than 1.5 million rapid test strips, cassettes, and uncut sheets per month to meet the government tender's requirements of high volume, and export orders without any bottle neck.

Automated Striping

Micro-volume automated striping for accurate line sharpness, flow rate and sensitivity.

Automated Packaging & Assembly

High-speed ultrasonic cassette sealing, foil pouching and fully customized box pack sizes to meet market needs.

Our Mission

To empower global healthcare networks with high sensitivity, room temperature stable diagnostic tools that enable fast clinical triage and stop disease spread at the source.

Our Vision

To set the global benchmark in diagnostic manufacturing through uncompromising batch consistency, rapid production capacity, and total regulatory transparency worldwide.

Core Values

  • 2017: Foundation & Cleanroom Setup in Saha (Ambala).
  • 2019: Launch of High Sensitivity Rapid Diagnostic Test Line.
  • 2021: Infrastructure Expansion for the High Volume Reagent Production.
  • 2023: ISO 13485 and the Certifications for International Export Attained.
  • Present: Trusted Partner for the Global Tenders, OEMs and Public Health Networks.