What Granulation Technology does

Granulation Technology, Inc. (GTI / GTI Pharmaceuticals) is a privately held, US-based pharmaceutical contract manufacturing organization founded in 1997 by Ashok G. Nigalaye and headquartered at a 35,000 sq. ft. cGMP facility in Fairfield, New Jersey. The company provides custom granulation, formulation development, analytical services, and commercial-scale manufacturing of oral solid dosage forms (tablets and capsules) for OTC and prescription pharmaceutical products. Its core technical capabilities span wet and dry granulation, encapsulation with capsule banding, tablet compression, film coating, powder blending, and packaging (including blister and pouch), complemented by pre-formulation studies, Quality by Design methodology, API evaluation, bioequivalence management, forced degradation studies, and ICH-aligned stability studies. The company is FDA GDUFA listed, DEA registered to handle Class III-V controlled substances, cGMP compliant, ISO 9001 certified, and holds Kosher and Halal certifications.

The company's commercial portfolio includes three FDA-approved branded generic products: Methocarbamol Tablets (500 mg and 750 mg, approved April 2021), Carisoprodol Tablets (350 mg, approved October 2021), and Prednisone Tablets (5 mg, 10 mg, and 20 mg, approved December 2023). Under the leadership of President Amit Nigalaye (appointed 2017), GTI operates with approximately 25 professionals serving pharmaceutical clients ranging from small businesses to Fortune 500 companies through direct B2B sales relationships. Revenue is generated primarily through project-based contract manufacturing engagements, with pricing negotiated per engagement rather than publicly disclosed. The company has no disclosed external funding, no parent organization, and remains family-owned; its operating footprint is limited to the United States.

Name

Granulation Technology

Legal name

Granulation Technology, Inc.

Website

https://granulationtech.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

11–50 employees

Short description

Granulation Technology is a privately held US pharmaceutical contract manufacturer in Fairfield, NJ offering custom granulation, formulation, analytical services, and commercial manufacturing of oral solid dosage forms. It also markets three FDA-approved branded generic products and serves clients from SMBs to Fortune 500.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

akta.pro secondary industries

CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD), Formulation & Preclinical CMC Support (Nonclinical) (HLAGAFAL)

Keywords

• Pharmaceutical contract manufacturing
• Oral solid dosage forms
• Granulation services
• Generic drug manufacturing
• CGMP pharmaceutical production

Headquarters

HQ city

Fairfield

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Operations, Personnel, Infrastructure, Technology or R&D, Marketing or Sales, Supply Chain, Others

Revenue model

1. Contract Pharmaceutical Manufacturing: Revenue generated from providing contract manufacturing services for pharmaceutical products including granulation, encapsulation, tableting, coating, and packaging of OTC and prescription drugs. The company serves as a CMO (Contract Manufacturing Organization) for small to Fortune 500 pharmaceutical companies.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Granulation Technology, Inc. (GTI) is a pharmaceutical contract manufacturing organization that provides custom granulation, formulation development, analytical development, and cGMP-compliant manufacturing of oral solid dosage forms (granules, capsules, tablets, coated tablets) for OTC and prescription drug products. The company also develops, manufactures, and distributes its own FDA-approved generic tablet products including Prednisone, Carisoprodol, and Methocarbamol tablets.

Product overview

Granulation Technology, Inc. is a pharmaceutical manufacturing company offering a portfolio of FDA-approved tablet products and contract manufacturing services. The company manufactures and distributes three branded generic drug products: Prednisone Tablets (5 mg, 10 mg, 20 mg), Carisoprodol Tablets (350 mg), and Methocarbamol Tablets (500 mg, 750 mg) in various count sizes. These pharmaceutical tablets are supported by comprehensive contract development and manufacturing services including wet and dry granulation, encapsulation, tableting (compression), film coating, capsule banding, blending, and packaging of tablets and powders. The company also provides formulation development for immediate and controlled release oral solid dosage forms, analytical development services including method validation and stability studies, and product development solutions encompassing pre-formulation studies, pharmacovigilance, and API evaluation. The company operates as a FDA GDUFA listed facility with cGMP manufacturing capabilities serving clients from small to Fortune 500 companies.

Differentiator

Problem solved

Functional benefit

Products and services

• Contract Pharmaceutical Manufacturing Services cGMP contract manufacturing services for oral solid dosage forms including wet and dry granulation, encapsulation (with capsule banding), tablet compression, film coating, powder blending, and packaging (tablet, powder, pouch, and blister). Services cover OTC and prescription products, with DEA registration supporting Schedule III-V controlled substances. Targeted at pharmaceutical companies needing FDA-compliant manufacturing partners.
• Product Development Services

Quantifiable outcome

• Successfully serving clients since 1997
• +1 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature13 records

Scale indicators5 records

Recent moves7 records

Expansion highlights3 records

Direct peers

• Alcami Corporation: US-based CDMO offering oral solid dose development and manufacturing, analytical services, and stability testing. Most directly comparable mid-market peer to GTI on service mix and customer segment.
• Metrics Contract Services: Specialty CDMO providing oral solid dose formulation development, analytical services, and clinical/commercial manufacturing for pharma clients. Strong overlap with GTI's granulation, tableting, and packaging services.
• Pharmaceutics International Inc (Pii): US-based CDMO with cGMP oral solid dose manufacturing, pre-formulation, formulation development, and analytical services. Near-identical capability profile to GTI's full-stack offering.
• Halo Pharma: Specialty CDMO focused on oral solid dose dosage form development and manufacturing (including controlled substance handling), serving pharma from preclinical through commercial. Closely aligned with GTI's core competency.
• Particle Sciences (Lubrizol Life Science): CDMO providing formulation development, analytical services, and complex generic drug product development including oral solids. Overlaps with GTI on formulation, pre-formulation, and contract manufacturing.
• Lifecore Biomedical: US-based CDMO offering aseptic fill-finish and increasingly oral solid dose development and manufacturing. Adjacent CDMO serving similar pharma customers with overlapping regulatory/compliance profile.

Broad incumbents

• Siegfried Holding: Swiss-headquartered CDMO with global oral solid dose manufacturing footprint including US sites. Comparable offering on tableting, granulation, encapsulation, and packaging for pharma clients worldwide.
• Catalent: Global large-scale CDMO with extensive oral solid-dose, granulation, encapsulation, and tableting capabilities serving pharma and biotech. Highly comparable offering to GTI but at vastly greater scale and multi-site footprint.
• Thermo Fisher Scientific (Patheon Pharma Services): Acquired Patheon to become one of the largest pharmaceutical CDMOs globally, offering oral solid dose, sterile, and API services. Overlaps with GTI on formulation, granulation, and commercial-scale manufacturing.

Emerging players

• Aprecia Pharmaceuticals: US-based specialty pharma CDMO/manufacturer with cGMP oral solid dose capabilities including 3D-printed formulations. Comparable in scale and service offering to GTI with differentiated technology.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/granulation-technology-inc

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Granulation Technology