CDMO

HAB Pharma offers integrated CDMO and manufacturing services, backed by over three decades of pharmaceutical manufacturing experience and an established production network in India. With three WHO-GMP-certified facilities and an annual production capacity of 4.4 billion+ units, we support pharmaceutical partners with consistent, large-scale manufacturing across a broad range of dosage forms.

Our approach brings together formulation expertise, established manufacturing processes and regulatory alignment to support products from development through commercialisation. Supported by integrated R&D capabilities and technology transfer expertise, we focus on developing formulations with the stability, scalability and process consistency required for commercial production.

Global Markets Served

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WHO-GMP Certified Facilities

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Years of Experience

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From Development to Commercial Manufacturing

HAB Pharma operates as an integrated CDMO partner, connecting formulation development, analytical evaluation, technology transfer and commercial manufacturing within a coordinated development pathway. This integrated approach supports continuity from early-stage development to production at commercial scale.

Formulation Development and Technology Transfer

We support the development of stable, effective formulations and their transition to manufacturing. Technology transfer is structured to maintain process consistency while establishing the foundation for scalable production.

Analytical and Quality Systems

Validated analytical methods and structured quality systems support product integrity throughout development and manufacturing. These processes help establish consistency, evaluate product stability and maintain appropriate quality controls.

Manufacturing and Scale-Up

Our multi-facility manufacturing network supports the transition from pilot batches to commercial volumes. Established production processes and flexible capacity enable scale-up while maintaining process consistency.

Regulatory Support

Documentation, quality compliance and coordinated project execution form part of our approach to regulatory alignment. These systems support the development and manufacturing process across relevant stages of the product lifecycle.

Comprehensive Pharmaceutical Manufacturing Capabilities

HAB Pharma’s manufacturing infrastructure spans key pharmaceutical dosage forms, supported by formulation development capabilities for specialised product requirements. Our R&D capabilities extend to complex formulations, including modified-release systems, enteric coatings and specialised drug-delivery platforms, supporting the development of differentiated products.

Tablets and Capsules

Oral solid dosage forms supported by established manufacturing capabilities across our production network.

Injectable Formulations

Dedicated sterile manufacturing capabilities for injectable products.

Oral Liquids and Drops

Manufacturing capabilities for liquid formulations and drop-based dosage forms.

Ointments and Topical Preparations

Production capabilities spanning topical formulations and external preparations.

Aerosols and Oral Jelly Formats

Specialised dosage-form capabilities encompassing aerosols and oral jelly products.

Multi-Facility Manufacturing Capabilities

HAB Pharma’s manufacturing network comprises three facilities across Vasai, Mumbai, and Selaqui, Dehradun, operating across six production blocks and supported by a workforce of 600+ professionals.

This integrated network provides operational flexibility, enables efficient allocation of production loads and supports consistent manufacturing output across markets. The combined capabilities of our facilities include:

Quality Systems and Regulatory Readiness

Quality is integral to HAB Pharma’s approach to pharmaceutical development and manufacturing. Our facilities are WHO-GMP-certified, and our quality systems are aligned with ISO 9001:2015 requirements.

Guided by Quality by Design principles, our approach emphasises the importance of consistency, stability and product performance from the formulation stage onwards. Structured quality assurance frameworks, documented processes and established controls support process oversight from R&D through commercial production.

By integrating quality considerations throughout the development and manufacturing pathway, we work to support reproducibility, regulatory readiness and consistent manufacturing outcomes.

From Formulation to Commercial Manufacturing

HAB Pharma follows a structured development pathway to support the transition from an initial formulation concept to commercial production. Each stage contributes to establishing product characteristics, evaluating stability and preparing the formulation for manufacturing.

Global Supply Capabilities

HAB Pharma supplies products to international markets across multiple regions. Our export reach includes:

Why Partner With HAB Pharma?

Together, these capabilities position HAB Pharma to support pharmaceutical partners
seeking an experienced manufacturing collaborator across development, technology
transfer and commercial production.

PILLAR 01 END-TO-END CDMO VELOCITY

An Integrated Development-to-Manufacturing Model

Our CDMO capabilities connect formulation development, technology transfer and commercial production within a coordinated framework, supporting continuity throughout the product lifecycle.

sync_alt Continuous Stage-Gate Methodology
Zero-Loss Scale-Up Telemetry Workflow ICH Q8 / Q9 / Q10 Standardized Flow
Node 01 // Formulation Hub 1

Formulation R&D (Vasai)

Pre-formulation chemistry, API compatibility screenings, reverse engineering, and lab-scale trial batches.

Pilot Scale Units: 10kg – 50kg
Stability Chambers: ICH Zone IVb (40°C/75% RH)
Analytical Method Dev: HPLC / UPLC / GC-MS
Node 02 // Protocol Bridge 2

Tech Transfer Protocol

Standardized BMR/BPR translation, process validation matrices, and analytical parameter qualification.

Scale-up Factor: 1:100 Seamless Transition
Critical Process Params: 100% CQA Mapped
Validation Runs: 3 Consecutive Clean Batches
Node 03 // Production Complex 3

Commercial Manufacturing (Dehradun)

High-throughput automated compression, encapsulation, aseptic filling, and multi-market commercial packaging.

Automated Packaging: Alu-Alu / Blister / Strip
Commercial Yield: > 99.4% Throughput
Batch Traceability: 2D Barcode Serialization
PILLAR 02 CAPACITY INFRASTRUCTURE
Active Capacity

Established Manufacturing Scale

Three WHO-GMP-certified facilities, six production blocks and an annual production capacity of 4.4 billion+ units provide a manufacturing platform designed to support diverse production requirements.

4.4B+ Units Annually Comprehensive annual production capacity
3 Plants WHO-GMP Certified Modern audited multi-site facilities
6 Blocks Production Blocks Dedicated segregated cleanroom suites
High-speed pharmaceutical packaging and automation line in Dehradun facility
Dehradun Automated Packaging Line No. 4 Class 100,000 (ISO 8) Controlled Air Filtration Systems
240 Blisters/Min
PILLAR 03 FORMULATION SPECTRUM

Broad Dosage-Form Capabilities

From tablets and capsules to injectables, liquids, topical preparations and specialised formats, our manufacturing network accommodates a wide range of pharmaceutical dosage forms. R&D capabilities also extend to complex formulations, including modified-release systems and enteric coatings.

pill
Oral Solid Dosages CORE SCALE

Tablets (uncoated, film, bilayer), Capsules & Multi-particulate Pellets

vaccines
Sterile Injectables ASEPTIC

Ampoules, Vials, and Lyophilised preparations in isolator units

sanitizer
Topicals & Semi-Solids DERMA

Ointments, Creams, Gels and topical emulsions

water_bottle
Liquid Orals & Suspensions ORAL FLUIDS

Syrups, pediatric drops, and homogeneous liquid suspensions

science
Specialised Formats R&D SPECIALTY

Modified-release (SR/ER), Enteric-coated & Taste-masked microgranules

Dossier Compatibility: CTD / ACTD / eCTD Standard
PILLAR 04 REGULATORY MATURITY
Audited Quality Systems

Quality and Regulatory Alignment

Quality systems, structured documentation and established process controls underpin our approach to development and manufacturing, supporting consistency and regulatory readiness.

Analytical HPLC chromatography research and development lab in Vasai
Vasai Analytical Center Continuous In-line HPLC & Dissolution
verified_user ALCOA+ Data Integrity

21 CFR Part 11 electronic batch audit trails and automated instrument logs.

description CTD & eCTD Dossiers

Full readiness for Modules 2 & 3 (Quality Overall Summary & Body of Data).

gavel Multi-Agency Approvals

WHO-GMP, NAFDAC, Iraq MoH, Uganda NDA & Libya FDA verified compliance.

WHO-GMP Validated NAFDAC Certified Iraq MoH Approved Uganda NDA Active Libya FDA Registered
PILLAR 05 CROSS-BORDER REACH

International Market Experience

With products supplied across South Asia, Southeast Asia, the Middle East, Africa and Latin America, HAB Pharma brings experience in serving pharmaceutical markets across multiple regions.

public South & SE Asia Fast-Track ACTD dossiers
pin_drop Middle East (MENA) MoH & Tender division
flag Sub-Saharan Africa Institutional supplies
near_me Latin America Bilingual packaging
Cold-Chain & Ambient Fulfilment 99.4% OTIF

Validated climate-controlled shipping logistics with calibrated real-time data loggers ensuring ICH stability conditions from facility gates to discharge port.

Documentation Readiness: CoA / Free Sale Cert / CPP

Start Your Manufacturing Partnership

Partner with HAB Pharma for contract development and manufacturing services built around established expertise, scalable production capabilities and a quality-driven approach.

habpharma