What Hanmi Fine Chemical does

Hanmi Fine Chemical Co., Ltd. (한미정밀화학) is a South Korea-based Active Pharmaceutical Ingredient (API) manufacturer founded in 1984 and operating as a subsidiary of Hanmi Pharmaceutical Group. The company is headquartered in Siheung-si, Gyeonggi-do, and employs 251-500 staff across manufacturing facilities including Cephalosporin Plants (A, B, D), a General Plant (C), and supporting warehouses with 160+ tons of capacity. Hanmi Fine Chemical supplies APIs and intermediates to global pharmaceutical manufacturers in 40+ countries, holding GMP certifications from US FDA, Japan PMDA, UK MHRA, Australia TGA, Germany BSG/BGV, Mexico COFEPRIS, Portugal Infarmed, and Korean MFDS, plus European Pharmacopoeia CEP certificates for key Cephalosporin APIs.

The company's product portfolio spans three pillars: (1) Cephalosporin antibiotics including sterile injectable APIs (Ceftriaxone Sodium, Cefotaxime Sodium, Ceftizoxime Sodium, Ceftazidime, Cefotiam HCl) and oral forms (Cefdinir, Cefixime), with proprietary thiazole compound synthesis patents held in the US, Japan, and Korea; (2) General APIs across cardiovascular, CNS, metabolic, anti-infective, and respiratory therapeutic areas (Rosuvastatin Calcium, Duloxetine HCl, Pregabalin, Febuxostat, Ezetimibe, Montelukast Sodium, Atorvastatin, Losartan, and others), plus Incrementally Modified Drugs (IMDs) with modified salt/crystal forms; and (3) newer platforms including HanmiCap® mRNA cap analogs (07, 11, 13, 20), GMP-grade PEG derivatives (PEG 3.4K, PEG 10K), high-purity peptide synthesis with proprietary resin, and mRNA raw materials (modified NTPs, LNP lipids). The company also provides CDMO services spanning preclinical to commercial stages including process development, analytical method development, GMP clinical sample production, and CTD/CMC documentation.

Hanmi Fine Chemical operates a B2B direct sales model targeting Big Pharma and generic pharmaceutical manufacturers. Named customers include Boehringer Ingelheim, Eli Lilly, Genentech (Roche), MSD, Sanofi, Astellas, Janssen (Johnson & Johnson), Spectrum Pharmaceuticals, Athenex, and its parent Hanmi Pharmaceutical. The company maintains dedicated technical sales and CDMO coordination teams, including Japan-focused personnel, with sales offices in Tokyo and London supporting global market development. Pricing is inquiry/quote-based and not publicly disclosed; HanmiCap® products include free initial test samples (≤0.1ml) with no additional running royalties. R&D investment exceeds 7% of sales, characterized as the highest level among same-industry companies, sustaining continuous product development and process improvement.

Name

Hanmi Fine Chemical

Legal name

Hanmi Fine Chemical Co., Ltd.

Website

https://hanmifc.co.kr

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

251–500 employees

Short description

Hanmi Fine Chemical is a South Korean Active Pharmaceutical Ingredient (API) manufacturer founded in 1984, supplying Cephalosporin antibiotics, general APIs, peptides, PEG derivatives, and mRNA materials (HanmiCap®) to global pharmaceutical companies across 40+ countries with US FDA, EU, and Japan GMP certifications.

Ownership category

akta.pro rank

Product category

Active Pharmaceutical Ingredients (APIs)

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Small-Molecule API & Intermediates CDMO (HLAGABAA)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Active pharmaceutical ingredients
• Cephalosporin antibiotic APIs
• MRNA cap analogs
• Contract manufacturing services
• Peptide PEG derivatives

Headquarters

HQ city

Sihung

HQ country

South Korea

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. API Manufacturing and Export: Core revenue from manufacturing and exporting Active Pharmaceutical Ingredients (APIs) including Cephalosporin antibiotics, General APIs, Peptides, and PEG derivatives. Products exported to over 40 countries globally.
2. CDMO Services: Contract Development and Manufacturing Organization services for pharmaceutical companies. Covers preclinical to commercial stages including process development, analytical method development, GMP clinical sample production, and CTD/CMC documentation preparation.
3. mRNA Materials (HanmiCap®): Sale of proprietary mRNA cap analogs and related materials to biotech and pharmaceutical companies developing mRNA vaccines and therapeutics.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Hanmi Fine Chemical manufactures and exports Active Pharmaceutical Ingredients (APIs) including Cephalosporin antibiotics (sterile and oral forms), general small-molecule APIs, peptides, PEG derivatives, and proprietary HanmiCap® mRNA 5'-cap analogs to pharmaceutical companies in over 40 countries. The company also operates a CDMO business providing contract development and manufacturing services spanning process development, analytical method development, GMP clinical sample production, and CTD/CMC regulatory documentation for global Big Pharma partners including Boehringer Ingelheim, Eli Lilly, MSD, Sanofi, Astellas, and Janssen.

Product overview

Hanmi Fine Chemical is a Korean Active Pharmaceutical Ingredient (API) manufacturer established in 1984, operating as a platform company offering three core product lines: (1) HanmiCap® mRNA 5'-cap analogs (HanmiCap®07, HanmiCap®11, HanmiCap®13, HanmiCap®20) for mRNA therapeutics and vaccines; (2) Cephalosporin antibiotic APIs including injectable forms (Sterile Cefotaxime Sodium, Sterile Ceftriaxone Sodium, Sterile Ceftizoxime Sodium, Sterile Ceftazidime, Sterile Cefotiam HCl) and oral forms (Cefdinir, Cefixime); and (3) General APIs spanning therapeutic areas including cardiovascular (Rosuvastatin Calcium, Atorvastatin Strontium, Losartan Potassium, Irbesartan), CNS (Duloxetine HCl, Pregabalin), metabolic (Febuxostat, Pioglitazone HCl), anti-infective (Clarithromycin, Moxifloxacin HCl, Itraconazole), and respiratory (Montelukast Sodium, Bepotastine Besilate). Additionally, the company offers IMDs (Incrementally Modified Drugs) with modified salts/crystal forms (Esomeprazole Strontium, Vildagliptin HCl, Clopidogrel Besylate) designed to circumvent original patents. The company also provides CDMO services for process development, GMP manufacturing, and regulatory documentation, along with peptide synthesis and PEG derivative manufacturing. Products are exported to over 40 countries with GMP certifications from US FDA, EU, Japan PMDA, and other regulatory authorities.

Differentiator

Problem solved

Functional benefit

Brands

• HanmiCap®: mRNA 5'-cap analog products including HanmiCap®07, HanmiCap®11, HanmiCap®13, and HanmiCap®20 for mRNA vaccine and therapeutic applications
• Rosuzet®

Products and services

• HanmiCap®07 mRNA 5'-cap analog (7-methyl-3' mesyloxy-guanosine-5'-triphosphate-5'-2' methoxy-adenosine-3'-monophosphate-5'-guanosine) for cap-dependent translation in mRNA therapeutics; designed to reduce innate immunity, simplify phosphorylation/purification steps, and enhance translation efficiency. GMP-ready samples available. Sold to biotech and pharmaceutical companies developing mRNA vaccines and therapeutics.
• HanmiCap®11 Self-amplifying RNA (saRNA) Cap analog (7-methyl-3'mesyloxy-guanosine-5'-triphosphate-5'-2'methoxy-adenosine-3'-monophosphate-uridine) for saRNA applications; reduces phosphorylation and purification steps; designed to reduce innate immunity for exogenous mRNA. Sold to mRNA therapeutics developers.
• HanmiCap®13 mRNA 5'-cap analog (7-methyl-3' mesyloxy-guanosine-5'-(2-mercaptotriphosphate)-5'-2' methoxy-adenosine-3'-monophosphate-5'-guanosine 3 sodium salt) for cap-dependent translation in mRNA therapeutics. Sold to mRNA vaccine and therapeutic developers.
• HanmiCap®20 Modified mRNA 5'-cap analog containing N1-methylpseudouridine for enhanced stability and reduced immunogenicity in mRNA therapeutics. Sold to biotech and pharmaceutical companies developing modified mRNA vaccines and therapeutics.
• Cephalosporin Antibiotic APIs Portfolio of Cephalosporin antibiotic APIs for global pharmaceutical manufacturers, including Sterile Ceftriaxone Sodium (first Korean sterile drug to receive US FDA approval in 2008), Sterile Cefotaxime Sodium (first Korean Cephalosporin, 1984), Sterile Ceftizoxime Sodium (supplied to Astellas as authorized generic), Sterile Ceftazidime, Sterile Cefotiam HCl, Cefdinir, and Cefixime. Includes Sterile Dried Sodium Carbonate excipient for injectable formulations. Products supplied to MSD, Astellas, Boehringer Ingelheim, Eli Lilly, Genentech, and others.
• General APIs (Small-Molecule) Portfolio of general small-molecule Active Pharmaceutical Ingredients spanning cardiovascular (Rosuvastatin Calcium for MSD Rosuzet®, Atorvastatin Strontium, Losartan Potassium, Irbesartan, Amlodipine Camsylate), CNS (Duloxetine HCl, Pregabalin), metabolic (Febuxostat, Pioglitazone HCl), anti-infective (Clarithromycin, Moxifloxacin HCl, Itraconazole), respiratory (Montelukast Sodium, Bepotastine Besilate), anti-inflammatory (Aceclofenac), anti-histamine and other therapeutic areas. Supplied to global generic and branded pharmaceutical manufacturers.
• Incrementally Modified Drugs (IMDs) Incrementally Modified Drug APIs with proprietary salt and crystal modifications designed to bypass original patents and improve physical/chemical properties, including Esomeprazole Strontium 4H2O (first Korean pharmaceutical company to register Esomezole in USP, 2017), Vildagliptin HCl, Dapagliflozin L-Proline, Clopidogrel Besylate, Clopidogrel Napadisilate H2O, Solifenacin Tartrate, Tenofovir Disoproxil Phosphate, Amlodipine Camsylate, and Bepotastine Calcium 2H2O. Developed using FDA-certified salts for enhanced safety and intellectual property circumvention.
• Peptide Synthesis Services GMP-based high-quality peptide manufacturing using a proprietary independently-developed resin (patent application filed) and professional synthesis technology. Capabilities include strategic synthesis methods tailored to peptide sequence, purification expertise, and impurity profiling for minimization. Targeted at global pharmaceutical and biotech companies requiring peptide APIs for therapeutic and diagnostic applications.
• PEG Derivatives GMP-compliant PEG derivatives including PEGylated peptide linkers, mRNA PEG lipids, heterobifunctional PEG, and standard PEG (PEG 3.4K, PEG 10K) for biopharmaceuticals, mRNA vaccines, therapeutics, and ADC drugs. Supplied to Sanofi (PEG 3.4K for Efpeglenatide), Janssen (PEG 10K for Efinopegdutide), and MSD (PEG intermediates).
• mRNA Raw Materials (Modified Nucleosides, NTPs, and LNP Lipids) Modified nucleoside and NTP materials including base-modified NTPs (5-Methyl-CTP, N1-Methylpseudo-UTP) and sugar-modified NTPs, plus LNP components (cationic lipid, PEG-lipid) for mRNA vaccine and therapeutic development. Sold alongside HanmiCap® cap analogs to biotech and pharmaceutical companies.
• CDMO Services Contract Development and Manufacturing Organization services covering process development, analytical method development, GMP clinical sample production, and CTD/CMC documentation preparation for small molecules, peptides, and PEG products from pre-clinical through commercial stages. Engaged by Boehringer Ingelheim (Olmutinib), Eli Lilly (Poseltinib), Genentech (Belvaragenib), MSD, Sanofi, Janssen, Astellas, and Athenex.
• Oligonucleotide Purification Purification services for oligonucleotides including peptide nucleic acids, leveraging advanced analytical equipment (HPLC, LC/GC, NMR, MS) and proprietary purification know-how. Targeted at oligonucleotide therapeutic developers.
• Ceftazidime for Injection (+DSC) Injectable Cephalosporin antibiotic API with differential scanning calorimetry specification for enhanced quality control, for severe infection treatment.

Quantifiable outcome

• First Korean company to develop Cefotaxime synthesis method
• +4 more outcomes

Named customers10 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• Eli LillycoreStrategic or Co-development Partner · 1 January 2015Licensing agreement for HM71224 (Poseltinib) for autoimmune disease in 2015. Hanmi Fine Chemical supplied API for clinical trials to Eli Lilly. Rights were returned to Hanmi in 2019.
• RochecoreStrategic or Co-development Partner · 1 January 1989Historical technology export partnership for Ceftriaxone Know-How to original manufacturer Roche in 1989 - first such technology export from Korea.
• Boehringer IngelheimcoreStrategic or Co-development PartnerCDMO partnership for HM61713 (Olmutinib) anticancer drug in Phase II clinical development. Hanmi Fine Chemical manufactures and supplies API to Boehringer Ingelheim. Partnership with BI (Worldwide) and Zai Lab (China). Rights were returned to Hanmi in 2017.
• Spectrum PharmaceuticalscoreStrategic or Co-development PartnerPartnership for HM781-36B (Poziotinib). Hanmi Fine Chemical supplies key intermediate to designated manufacturer for Korea and US markets.
• Genentech (Roche)coreStrategic or Co-development PartnerPartnership for HM95573 (Belvaragenib) Phase I clinical development. Hanmi Fine Chemical provided API for clinical trial to Genentech.
• Astellas PharmacoreStrategic or Co-development PartnerAuthorized generic partnership for Ceftizoxime for worldwide markets. Hanmi Fine Chemical supplies API as one of the top quality APIs in the world. Product registered as standard in China.
• MSD (Merck & Co.)coreStrategic or Co-development PartnerSupply partnership for Rosuvastatin API for Rosuzet® dual-action hyperlipidemia drug (Rosuvastatin + Ezetimibe). Also PEG intermediates for efinopegdutide development.
• SanoficoreStrategic or Co-development PartnerCDMO partnership for PEG 3.4K (Efpeglenatide intermediate), CA-Exendin 4 intermediate, and GLP/GCG related intermediates.
• Janssen (Johnson & Johnson)coreStrategic or Co-development PartnerCDMO partnership for PEG 10K (Efinopegdutide intermediate) and GLP/GCG related intermediates.
• AthenexminorStrategic or Co-development PartnerCommercial supply partnership for HM30181A PgP Inhibitor for anticancer treatment. Hanmi Fine Chemical supplied API to Athenex.
• Hanmi PharmaceuticalcoreStrategic or Co-development PartnerParent company partnership for CDMO services including triple agonist GLP-2, Glucagon development. Original development of HM61713, HM71224 compounds. Part of Hanmi Pharmaceutical Group.

Scale indicators6 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Lupin Limited: Indian global pharmaceutical manufacturer with API and finished-dose operations. Lupin is a direct peer in generic API manufacturing, particularly in Cephalosporins and complex small molecules, serving similar Big Pharma and generic customers globally.
• Aurobindo Pharma: Indian vertically integrated generic API and finished-dose manufacturer with FDA/EMA-approved facilities and a Cephalosporin franchise. Aurobindo is a direct competitor in generic APIs and Cephalosporins serving regulated markets, with comparable export-oriented business model.
• SK Biotek: South Korea-based CDMO specializing in small-molecule API development and manufacturing. SK Biotek is the closest geographic and capability peer to Hanmi Fine Chemical, both operating from Korean industrial complexes with similar small-molecule, steroid, and CDMO offerings to Big Pharma.
• Dr. Reddy's Laboratories: Indian pharmaceutical company with significant API manufacturing operations and global generic finished-dose business. Dr. Reddy's competes directly with HFC in supplying generic APIs (Cephalosporins, cardiovascular, CNS) to regulated markets under similar FDA/EMA filings.
• Zhejiang Huahai Pharmaceutical: Chinese API manufacturer with FDA/EMA-certified facilities focused on cardiovascular, CNS, and anti-infective APIs. Huahai is a direct competitor in generic API exports to regulated markets, with comparable product categories to HFC's general API portfolio.

Broad incumbents

• Lonza Group: Swiss global CDMO with extensive small-molecule API, peptide, and biologics manufacturing across mammalian and microbial platforms. Lonza is a broader incumbent peer that competes for the same Big Pharma CDMO contracts as HFC, but at significantly larger scale and with a more diversified service portfolio.
• WuXi AppTec / WuXi STA: Chinese global CRO/CDMO with major small-molecule API manufacturing operations (WuXi STA). WuXi is a broad incumbent that competes with HFC for Big Pharma CDMO contracts, offering comparable end-to-end process development and commercial manufacturing at greater scale.
• Catalent: US-headquartered global CDMO with softgel, oral, sterile injectable, and biologics capabilities. Catalent competes for the same Big Pharma CDMO opportunities as HFC, though at much larger scale and with a broader delivery-format portfolio.

Emerging players

• Biocon Limited: Indian biopharmaceutical company with API and biologics operations serving global markets. Biocon is an emerging peer with overlapping capabilities in peptides, PEG derivatives, and generic APIs, increasingly competing in similar CDMO adjacencies to HFC.

Regional players

• Samsung Biologics: Korean biopharmaceutical CDMO focused on biologics contract manufacturing. While centered on mammalian-cell biologics rather than small molecules, Samsung Biologics is a Korean CDMO peer that benefits from the same Korea-anchored Big Pharma relationships and regulatory ecosystem.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

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 Hanmi Fine Chemical