Small Molecule API CDMOs

Chongqing Daxin Pharmaceutical Co., Ltd. is a Chinese API manufacturer with 3 FDA-registered facilities and CEP certifications from Europe. The company produces small molecule APIs including amikacin and kitasamycin, appearing in multiple contract manufacturing industry reports as a significant API manufacturer.

Chongqing Nansong Chemi-Tech Pharma Co., Ltd., founded in 1992, is a Chinese high-tech enterprise manufacturing pharmaceutical intermediates and APIs with CMO/CDMO capabilities. The company has 66,000 sq.m. of production facilities with reactor capacity over 300 cubic meters, specializing in hydrogenation, amination, and high-temperature vacuum distillation.

Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd. is a Chinese pharmaceutical manufacturer with an FDA-registered 3,600 sq.m. facility producing innovative APIs. The company has connections to Porton Pharma's leadership and appears in industry reports as a small molecule API manufacturer.

Dalian Join King Fine Chemical Co., Ltd. is a Chinese fine chemical company primarily focused on agrochemical and pharmaceutical intermediates, with custom synthesis and custom manufacturing capabilities. Founded in 1997 in Dalian, the company operates four production bases with a 120,000 sqm plant and seven intelligent workshops. The company is FDA-registered and provides contract manufacturing services for pharmaceutical intermediates.

Flow Eighteen38 is a protein sciences division within the FairJourney Biologics Group, based in Portugal, providing antibody characterization, protein production, and biophysical analysis services. It received 5 million euros to expand production and biophysical capabilities, serving the drug discovery and research community.

Grace Custom Pharma (Fine Chemical Manufacturing Services) is a division of W.R. Grace & Co. that provides contract pharmaceutical drug substance manufacturing services for custom APIs, registered starting materials, and intermediates. The company operates cGMP-compliant facilities and specializes in integrated scale-up from R&D through commercial production, emphasizing quality culture and compliance.

Grace Fine Chemical Manufacturing Services is the pharmaceutical CDMO arm of W.R. Grace & Co., providing contract drug substance manufacturing including custom APIs, registered starting materials, and generic APIs. This entity appears to represent the China-based operations of Grace's pharmaceutical fine chemicals division, operating alongside the US facilities in South Haven and Tyrone.

Guangdong Blue Treasure Pharmaceuticals is a Chinese joint venture pharmaceutical company founded in 1994, part of the Livzon Pharmaceutical Group, specializing in the production of APIs including Pravastatin Sodium (cardiovascular), Mycophenolic Acid (immunosuppressant), and Compactin/Mevastatin. The company operates multiple FDA-registered API manufacturing sites with a strong inspection history.

Hebei Jiheng Pharmaceutical Co., Ltd. is a Chinese API manufacturer and supplier specializing in Paracetamol (Acetaminophen) and related pharmaceutical ingredients. The company holds DMF and CEP certifications and is FDA-registered with multiple FEI numbers.

Huanggang LUBAN Pharmaceutical Co., Ltd. is a Chinese pharmaceutical company that manufactures APIs and intermediates, specializing in chiral intermediates and fine chemicals. The company is FDA-registered and participates in the contract small molecule API manufacturing industry.

Hubei Goto Biopharm Co., Ltd. is one of the largest manufacturers of steroid hormone APIs and intermediates in China. Founded in 2006, the company is fully committed to manufacturing, researching, and developing high-quality steroid hormone products, and also offers contract manufacturing services for APIs.

Hubei Sanjing Biotechnology Co., Ltd. is a Chinese manufacturer of steroid hormone APIs and intermediates, including products such as drospirenone and dehydronandrolone acetate. The company participates in the contract small molecule API manufacturing industry.

IMS srl Micronizzazioni is an Italian company based in Milan specializing in the micronization of active pharmaceutical ingredients (APIs) and excipients on behalf of third parties. The company has been inspected by the FDA multiple times (6 inspections, most recently in May 2024) and is positioned as a strategic partner in pharmaceutical micronization and controlled drug release.

Jay Chemicals (previously Jay Finechem Private Limited) is an Indian manufacturer of API intermediates and fine chemicals based in Vapi, Gujarat. The company is listed among top CMOs for small molecule API manufacturing facilities and is open to CDMO, CRO, and contract manufacturing opportunities.

J‑STAR Research, Inc.

United States

J-STAR Research is a contract process R&D and cGMP manufacturing organization (subsidiary of Porton Pharma Solutions) serving the pharmaceutical and biotech industry. Founded 1996, focused on small molecule drug substance and drug product development. Offers process chemistry R&D, crystallization R&D, high potent compound handling, controlled substances, analytical R&D, QC, and drug product formulation. Two NJ-based R&D centers totaling 129,000 SF. FDA registered with API MANUFACTURE operations.

Katwijk Chemie BV

Netherlands

Katwijk Chemie BV is a Netherlands-based pharmaceutical API manufacturer. Website is currently a domain parking page (no active company site), but CPHI listings and pharma databases confirm they manufacture and supply APIs including Sodium Valproate, Deferiprone, Phenytoin, and various intermediates. Listed as a manufacturer on CPHI Online with US DMF filings. FDA registered with 1 FEI number for API manufacture, 5 inspections (2 NAI, 3 VAI). Search results mention a production facility in Nanjing, China. They appear to be a small-to-mid-size API manufacturer, possibly with limited or inactive web presence.

Kekule Pharma Limited

India

Kekule Pharma Limited is a Hyderabad-based API and pharmaceutical intermediates manufacturer in India. Specializes in developing novel (patent non-infringing) processes for API synthesis. Offers custom synthesis, contract manufacturing, scale-up from kgs to tons, impurity synthesis, and regulatory documentation (DMFs in CTD format). Extensive product portfolio including oncology APIs (Capecitabine, Temozolomide, Imatinib, Gefitinib, Bortezomib), CNS (Escitalopram, Citalopram), GI (Pantoprazole, Famotidine), and others. FDA registered with 2 FEI numbers, 3 inspections (3 VAI).

Key Organics Limited is a UK-based custom synthesis and contract chemistry company, home of the BIONET screening compound collection of 344,000+ products. They offer fee-for-service synthetic organic chemistry, process development and scale-up (gram to kilogram scale), analytical services, fragment-based screening libraries, compound procurement, and consultancy. They operate at non-GMP kilo-scale for intermediates and do process development for GMP manufacture, but are primarily a research chemistry services company rather than a full cGMP API manufacturer. They work with clients in pharma, biotech, academia, and agrochemicals.

Laviana (Laviana Pharma Group) is a Chinese pharmaceutical company offering integrated CDMO and CRO services. Based on search results showing their website in Chinese, they offer one-stop CDMO services covering small molecules, APIs (raw materials), intermediates, innovative drugs, and customized GMP production. They provide preclinical research, drug selection, and CMC services. Limited English-language information available.

LinkChem Co., Ltd. is a Chinese high-tech enterprise founded in 2011, providing professional CDMO/CMO/CRO services for pharmaceutical companies. The company, part of the Linkchem Group (including Chemenu), specializes in custom synthesis of pharmaceutical intermediates and APIs from R&D to commercial scale manufacturing.

Loxim Industries Limited

India

Loxim Industries Limited is an Indian chemical manufacturing company (founded 1977) with divisions in Dyes, Engineering Plastics, and Pharmaceuticals. The pharmaceutical division manufactures APIs including Montelukast and Dabigatran. Primarily a chemical manufacturer with a pharma API segment, serving customers in 30+ countries. Not primarily a contract manufacturer -- manufactures APIs as part of their broader chemical business.

M2i Life Sciences

France

M2i Life Sciences is a French industrial group founded in 2012, specializing in the design, formulation, and production of complex molecules. Their CDMO division focuses on research, development, and production of active pharmaceutical ingredients (APIs), synthesis intermediates, specialty molecules, and pheromones. They operate across human health, animal health (veterinary formulation and microencapsulation), and biocontrol segments. They produce approximately 1,000 tonnes per year of reference products in pain relief, fever control, and cardiology for France and North Africa.

Mac-Chem Products (India) Pvt. Ltd.

India

Mac-Chem Products (India) Pvt. Ltd., part of the NMM Group (Naprod), is a pharmaceutical API manufacturer specializing in Oncology, General APIs, and Bulk Sterile products. They have manufacturing plants in four locations employing around 800 professionals. Naprod (parent) is a pioneer in lyophilization with an ultra-modern manufacturing facility. They hold multiple international regulatory approvals including USFDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, and WHO-GMP/ISO certifications.

Macrocyclics, Inc.

United States

Macrocyclics, Inc., founded in 1995 and headquartered in Plano, Texas, is a specialist CDMO for chelating agents used in radiopharmaceuticals. Their products support drug development programs worldwide by providing the chelators that attach radioactive isotopes to targeting vectors for cancer treatment. They offer GMP manufacturing with an advanced quality system for translating new molecules into clinical research, as well as research collaborations.

Morgen Pharmaceutical Services (MPhS), operating as Stason Pharmaceuticals, is a US-based CDMO offering end-to-end drug development and manufacturing services. Located in Irvine, California, the facility can produce over 2 billion oral doses per year with batch sizes from 0.5 kg to 600 kg. The company offers API synthesis (through offshore affiliates), formulation development, pre-formulation studies, solid dosage manufacturing (tablets and capsules), high-containment operations for highly potent compounds (OEL < 1 µg/m³), and injectable/liquid manufacturing through a partner facility in Tainan, Taiwan. FDA-registered with 2 FEI numbers and 11 FDA inspections (8 NAI, 3 VAI).

Indian pharmaceutical CDMO specializing in pre-finished formulation intermediates (PFI) and finished dosage forms (FDF). Manufactures oral solids, oral liquids, injectables, ophthalmics, topicals, and inhalation products. Strong focus on pellet technology and nanotechnology-based drug delivery systems. CRAMS (Contract Research and Manufacturing Services) provider.

Nagase & Co., Ltd.

Japan

Japanese conglomerate with a Healthcare & Pharmaceuticals division offering CDMO services including custom peptide API development and manufacturing, organic synthesis, contract manufacturing of liquid medicines, and pharmaceutical ingredient distribution. Core business is much broader (chemicals, polymers, electronics, food), but the pharma division provides genuine contract manufacturing capabilities.

NAM Group of Industries Pvt. Ltd.

India

Indian WHO-GMP certified manufacturer and exporter of pharmaceutical active pharmaceutical ingredients (APIs) for human and veterinary use, plus pharmaceutical intermediates and phase transfer catalysts. Not a contract manufacturer -- produces and sells own API portfolio. Headquartered in Mumbai with manufacturing plant in Ankleshwar, Gujarat. Facility covers 5,000 sqm with dedicated clean rooms for human and veterinary APIs.

Navin Molecular (Navin Fluorine CDMO)

India

CDMO division of Navin Fluorine International Limited, one of India's leading fluorochemical companies. Specializes in custom synthesis and contract manufacturing of fluorinated APIs, advanced intermediates, and specialty chemicals for pharmaceutical companies. Leverages deep expertise in fluorine chemistry for complex molecule synthesis. Offers services from process development through commercial-scale manufacturing.

NCK A/S (Niels Clauson-Kaas)

Denmark

Danish CDMO founded in 1956 specializing in process development and API manufacturing for biotech and pharma companies taking new chemical entities (NCEs) from discovery to commercialization. Operates a multi-purpose GMP pilot plant with glass/glass-lined reactors (40-280L) including cryogenic capability (-80 degrees C). Services include process development, analytical development, reference samples, supply of API for toxicology and clinical studies, API release, ICH stability studies, and GMP documentation. QC lab equipped with HPLC (DAD/CAD), IC, GC-MS, and LC-MS/MS (QTOF).

NEON LABORATORIES LTD

India

Indian pharmaceutical company (established 1984) that emerged as a leader in anesthesia and critical care products. Manufactures 500+ products sold in 70+ markets. Multi-located manufacturing facilities including API and formulations. Started as contract manufacturer for anesthesia products (1992) and grew into branded generics. Major plant at Palghar with 460 million units capacity. Has dedicated manufacturing units for cephalosporins and oncology to avoid cross-contamination. 2000+ employees. FDA registered with 3 FEI numbers, 29 inspections (13 NAI, 15 VAI, 1 OAI). Began API production in 2008. Also has medical devices division (HOSPRO).

Olon Ricerca Bioscience is a US-based CRO/CMO subsidiary of Olon SpA, specializing in chemical development and API manufacturing for preclinical and clinical phases. Founded in 1986 and acquired by Olon SpA in 2017, the company provides integrated services from synthetic chemistry and process development through to cGMP kilo-lab manufacturing at its Concord, Ohio facility.

Olon SpA is a global leader in the development and production of Active Pharmaceutical Ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and microbial biomanufacturing. The company operates 14 GMP facilities primarily in Italy, with additional sites in France (via GTP Bioways acquisition), the US, Germany, and China, with 450+ DMFs and 35+ years of regulatory experience.

Peptides International, founded in 1983, is a US-based custom peptide synthesis company now part of Biosynth's peptide division. The company operates from a 12,000 sq ft ISO 9001:2015 certified facility in Louisville, Kentucky, providing custom peptide synthesis and catalog peptide products. Previously merged with New England Peptide, the combined entity offers GMP peptide manufacturing capabilities as part of the broader Biosynth organization.

Pharma Links (UAE) is a pharmaceutical supplier serving as a one-stop-shop for pharmaceutical formulators worldwide. Based on search results, the company acts as a distributor and indenting company for pharmaceutical raw materials and APIs rather than a drug manufacturer. No website content was available for verification.

Praveen Laboratories Pvt Ltd is an Indian manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates for the pharmaceutical industry. Based in Surat, Gujarat, they export to 50+ countries. FDA-registered with FEI number 3005751252 for API manufacture and analysis. Listed on PharmaSource and CPHI Online as a leading API manufacturer with products including lamotrigine. They are not a contract CDMO but rather a dedicated API supplier.

Pressure Chemical Company (PCC) is a Pittsburgh, Pennsylvania-based specialty chemical and CDMO with over 50 years of experience. They specialize in high-pressure chemistry and specialty chemical manufacturing, including toll/contract manufacturing services. In 2025 they were acquired by Novopor Advanced Science (an Indian performance chemicals and material science CDMO), expanding Novopor's US footprint. PCC offers chemical contract manufacturing and specialty chemical processing services. Search results consistently reference them as a CDMO acquired by Novopor.

Quality Chemicals S.L. is a European chemical manufacturer based in Esparreguera, Barcelona, Spain, specializing in high-purity chemicals, laboratory reagents, CDMO contract manufacturing, fine chemical synthesis, and PSR (micronization and milling) services. The company has manufacturing facilities in Barcelona and Palencia, Spain. Note: The company's website (qcsa.es) appears to redirect to the Quality Corn agricultural subsidiary; the pharmaceutical CDMO operations are referenced in CPHI and PharmaSource listings. Quality Chemicals has 17 FDA-registered FEI numbers and an extensive regulatory inspection history.

RNP Pharmachem is an Indian pharmaceutical company providing CDMO/CMO services and site transfer project activities. The company operates a Singapore EU-GMP approved manufacturing facility and has 51-200 employees. Limited information is available about the company's specific capabilities and therapeutic focus beyond its general CDMO/CMO service offering.

Sinopep-Allsino Biopharmaceutical Co., Ltd. (Stock Code: 688076) is a Chinese innovation-driven company specializing in the development and manufacturing of peptide and oligonucleotide APIs and drug products. Listed on the Shanghai Stock Exchange, they operate as a full-service CDMO for complex peptide and oligonucleotide therapeutics. Their subsidiary Apextide Co., Ltd. is expanding with a large-scale manufacturing facility. The company has FDA-registered facilities with inspection history showing mostly compliant results.

SOMAI Pharmaceuticals is a Portuguese EU-GMP certified vertically integrated Multi-Country Operator (MCO) specializing in the manufacturing of medical-grade cannabis APIs and oral solutions. The company holds INFRAMED authorization for its Lisbon facility and has partnerships for distribution in the German market.

SQM-Ajay (Ajay-SQM Group) is the global leader in iodine derivatives, formed through a partnership between Ajay Chemicals and SQM (Sociedad Quimica y Minera de Chile), the world's largest iodine producer. The company has over 50 years of expertise in iodine chemistry and produces iodine derivatives and specialty chemicals for pharmaceutical, animal nutrition, human nutrition, electronics, industrial, agrochemical, biocide, and battery applications. They have API DMFs/CEPs listed and production facilities on three continents. While they supply pharmaceutical-grade iodine-based APIs, they are primarily a specialty chemical/API manufacturer rather than a contract drug product manufacturer.

Star Lake Bioscience Co., Inc. Zhaoqing Guangdong is a Chinese bioscience company founded in 1964 in Zhaoqing, Guangdong Province. They manufacture APIs and pharmaceutical intermediates including ribavirin and inosine. They are listed on CPHI Online as offering generic APIs and appear at major pharma trade shows (CPhI China). Their primary business appears to be API/intermediate production and supply rather than contract drug product manufacturing. They started as a small factory and have grown into a supplier of pharmaceutical ingredients.

Suzhou Jingye Medicine & Chemical Co., Ltd. (formerly Suzhou Daxin Chemical) is a Chinese national high-tech enterprise located in Suzhou High-tech Industrial Development Zone, specializing in the production and CDMO services of functional chemicals, key starting materials (KSMs), intermediates, and APIs. The company exhibits regularly at CPHI events.

Topharman Shanghai Co., Ltd. is a Chinese contract services company established in 2000, offering pharmaceutical R&D solutions including synthetic chemistry, process development, and CMO/CDMO services for APIs. The company provides custom synthesis and manufacturing services to global pharmaceutical partners.

USV Peptides is the peptide synthesis division of USV Private Limited, a 61-year-old Indian healthcare company originally founded as a joint venture with USV & P Inc. USA (Revlon subsidiary). They specialize in custom peptide synthesis and GMP-grade peptide manufacturing from their dedicated facility at Chiplun, Maharashtra. Capabilities include solid-phase and solution-phase peptide synthesis, peptidomimetics, conjugation, PEGylation, HPLC purification to >99% purity in multi-kg quantities, and full characterization (Mass, LC-MS, AAA, Ion Chromatography). They serve pharmaceutical, research, and cosmetic peptide markets globally.

Zach System is the chemical division of Zambon Company SpA, specializing in Active Pharmaceutical Ingredient (API) manufacturing, quality intermediates, and custom synthesis services for the pharmaceutical industry. Located in Avrille, France, with multipurpose equipment and reactors ranging from 50L to 10,000L.

ZCL Chemicals Limited (formerly Zandu Chemicals Ltd) is an Indian pharmaceutical API manufacturer established in 1991, now part of Cohance Lifesciences (formed by the merger of RA Chem Pharma, ZCL Chemicals, and Avra Laboratories). The company operates API and CDMO business with manufacturing facilities in India. No website was accessible at time of review.