MOREPEN LABORATORIES LIMITED
0+Years of pharmaceutical experience
0+Countries served
0 KLAPI / CDMO reactor capacity
0Consecutive NIL Form 483 inspections reported

Current installed API/CDMO reactor capacity: 614 KL. Inspection milestone: company disclosure dated 17 April 2026. Site-specific qualification applies.

Global pharmaceutical manufacturing

Chemistry, compliance
and scale — connected.

Morepen combines more than four decades of API manufacturing experience with an expanding CDMO platform, drug-product development capabilities and healthcare businesses. The focus is increasingly on long-duration global partnerships, regulated-market execution and science-led growth.

01SCIENCE

Deep chemistry foundation

Established small-molecule API expertise, process development and scale-up form the scientific base for higher-value customer programs.

02DEVELOPMENT

Integrated capabilities

Custom development, analytical work, technology transfer and selected drug-product programs connect development with manufacturing.

03MANUFACTURING

Regulated-market execution

Manufacturing infrastructure, quality systems and export experience support customers across regulated and emerging markets.

04PARTNERSHIP

Long-duration relationships

Morepen is expanding from transaction-led supply toward recurring programs, commercial CDMO execution and deeper global partnerships.

Pharmaceutical development & manufacturing

API strength.
Connected capabilities.

Morepen combines established API manufacturing with expanding development, analytical, scale-up and commercial manufacturing capabilities for global pharmaceutical partners.

01

Active Pharmaceutical Ingredients

A global API platform built on process chemistry, regulated-market manufacturing and long-standing customer relationships.

Explore capability
02

CDMO & Custom Development

End-to-end support from key intermediates and API/drug substance development through analytical work, scale-up, technology transfer and commercial supply.

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03

Drug Product Development

Formulation, analytical development, stability, regulatory batches and dossier support, demonstrated through the company's first U.S. ANDA submission.

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Stay informed

News & announcements

Business announcement

First U.S. ANDA submission expands integrated development

View announcement
Results announcement

Q1 FY27: commercial execution and record quarterly results

View announcement
Business announcement

Masulkhana inspection completed with NIL Form 483

View announcement

Selected recent publications · complete reports and disclosures in the Investor centre.

Morepen 2.0

From product supply to
deeper global partnerships.

APIs remain Morepen's scientific and manufacturing foundation. The current growth phase builds on that base through commercial CDMO programs, integrated development capabilities and disciplined expansion of manufacturing scale.

INR 8,250 million

CDMO mandate in commercial execution

INR 580 million commercial dispatches reported in Q1 FY27

Revenue mix

Growing contribution from longer-duration customer programs and value-added manufacturing.

Capability

Deeper process chemistry, analytical, regulatory and finished-dosage development capabilities.

Scale

Capacity expansion aligned with customer programs, utilities, quality systems and execution readiness.

Partnership

Greater emphasis on customer continuity, supply reliability and multi-year global relationships.

Manufacturing & supply

Scale backed by process
depth and execution.

614KL installed API / CDMO reactor capacity

Morepen's manufacturing network in Himachal Pradesh supports small-molecule APIs and CDMO programs for domestic and international customers. Expansion is being phased alongside customer demand, utilities, finishing areas, laboratories and environmental systems.

Baddi

High-volume manufacturing and expansion platform.

Masulkhana

Established API manufacturing and regulated-market track record.

Process scale-up

Technology transfer and manufacturing integration.

Supply continuity

Quality, reliability and customer commitments.

Explore manufacturing
Morepen manufacturing facility aerial view in Himachal Pradesh

Quality & regulatory compliance

Global trust is earned
through repeatable systems.

Quality, data integrity, regulatory readiness and continuity of supply are central to long-term pharmaceutical partnerships.

Four consecutive USFDA inspections reported with Nil Form 483 observations

MASULKHANA / 17 APRIL 2026

A site-specific quality milestone.

The April 2026 inspection at the Masulkhana API facility concluded without Form 483 observations. Morepen's wider regulatory footprint includes engagement across multiple regulated markets, with scope varying by site, product and filing.

Read the inspection disclosure
Quality & credentials
United States Food and Drug Administration logo
Health Canada logo
Taiwan FDA logo
WHO-GMP logo
Korea Food and Drug Administration logo
China NMPA logo
ANVISA Brazil logo
PMDA Japan logo
EDQM Europe logo
United States Food and Drug Administration logo
Health Canada logo
Taiwan FDA logo
WHO-GMP logo
Korea Food and Drug Administration logo
China NMPA logo
ANVISA Brazil logo
PMDA Japan logo
EDQM Europe logo

Our healthcare businesses

Different needs.
Distinct businesses.

Medical Devices, Rx and OTC each have a clear place in our healthcare story, alongside Morepen's pharmaceutical development and manufacturing platform.

Explore Healthcare Businesses
Dr. Morepen logoMedical devices
Dr. Morepen blood glucose meter held in handDr. Morepen Gluco One test-strip vial, historical packagingDr. Morepen automatic blood pressure monitor
MONITORING & CONSUMABLESMOREPEN HEALTHCARE

01 / Medical Devices

Everyday monitoring.
A recognisable brand.

Dr. Morepen blood glucose meters, strips and blood pressure monitors, with a dedicated chronic-care business focus.

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Morepen logoRx & prescription medicines
Cefopen-CV 50 package from the May 2024 Morepen presentationLasipen-40 Frusemide tablets cartonKlarim Clarithromycin 250 mg blister strips
PRESCRIPTION BUSINESSMOREPEN HEALTHCARE

02 / Rx & Prescription Medicines

Prescription medicines.
A dedicated business.

Morepen prescription brands, professional engagement and channel relationships, distinct from partner development services.

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Dr. Morepen logoOTC & consumer wellness
Burnol branded packaging from the May 2024 Morepen presentationLemolate branded packaging from the May 2024 Morepen presentation
RECOGNISABLE HEALTHCARE BRANDSMOREPEN HEALTHCARE

03 / OTC & Consumer Wellness

Familiar brands.
Everyday healthcare.

A corporate introduction to the Dr. Morepen OTC and consumer-wellness business, with a dedicated consumer destination.

Explore OTC

Representative branded artwork from supplied presentations. Current packs, device models and web-use permissions require approval before launch.

Build the next program together.

For APIs, development, analytical work or commercial manufacturing, start with a non-confidential discussion of your requirement.

Talk to our team