Oral Solid Dose CDMOs

Piramal Pharma Solutions (PPS) is a global CDMO under Piramal Pharma Limited, offering end-to-end development and manufacturing solutions across the drug lifecycle. Operates through a globally integrated network of 17 development and manufacturing facilities across North America, Europe, and Asia, with distribution in 100+ countries. Services include drug discovery, process/pharmaceutical development, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Specialized in highly potent APIs, antibody-drug conjugations, sterile fill/finish, and peptide products. Multiple CDMO Leadership Award winner.

Prime Health Ltd. is a contract manufacturer for natural health products, nutritional supplements, and pharmaceutical products. Based in Maple Ridge, British Columbia, Canada (not UK as listed), they have a modern facility with advanced equipment. Job postings mention production workers for tablet coating, quality control technicians, R&D technicians, encapsulation roles, and formulation technicians. FDA-registered with FEI 3021784212 with 1 FDA inspection (VAI in 2022). Also listed on PharmaSource as a contract manufacturer and appearing at CPHI Frankfurt. The UK-based Prime Health referenced by Apposite Capital appears to be a different entity (www.prime-health.co.uk).

Recordati is an Italian pharmaceutical company with both a proprietary product business (rare diseases, specialty/primary care) and a fine chemicals/CDMO division. Recordati Fine Chemicals (also known as Recordati Industria Chimica e Farmaceutica) provides contract API manufacturing. They have FDA-registered facilities, 26 approved products across multiple dosage forms, and significant industrial operations. The fine chemicals division offers API development and manufacturing services to third-party pharmaceutical companies.

Reliance Life Sciences (RLS), part of Reliance Industries, is a premier Indian biotechnology company providing contract manufacturing and development services across pharmaceuticals and biosimilars. They have FDA-registered manufacturing facilities with 7 FDA-approved products (injectables, powders, tablets). Their capabilities span API manufacturing, formulation development, biologics/biosimilar manufacturing, and cell and gene therapy R&D. They are a vertically integrated biotech company with 1,000-5,000 employees, offering CDMO services alongside their own product portfolio.

SEDICO Pharmaceutical Company is an Egypt-based pharmaceutical manufacturer and API producer, providing contract manufacturing (CMO/CDMO) services. The company manufactures a broad range of pharmaceutical products including oral solids, injectables, and various dosage forms. SEDICO has recently entered oncology drug production through a partnership with Sandoz Global to localize oncology pharmaceutical products in Egypt.

DUPLICATE ENTRY: This is the same company as Sri Krishna Pharmaceuticals Ltd (companyId: 12028a28). SKPL was established in 1974 and specializes in bulk manufacture of APIs, DC granules, and finished dosage forms. See primary entry for full profile.

DUPLICATE ENTRY: This is the same company as Sri Krishna Pharmaceuticals Ltd (companyId: 12028a28). SKPL was established in 1974 and specializes in bulk manufacture of APIs, DC granules, and finished dosage forms. See primary entry for full profile.

DUPLICATE ENTRY: This is the same company as Standard Chem. & Pharm. Co. Ltd (companyId: 6a650983). See primary entry for full profile. Standard Chem. & Pharm. Co., Ltd. (SCP) is a Taiwanese CDMO established in 1967.

STA Pharmaceutical Co., Ltd. (WuXi STA) is a subsidiary of WuXi AppTec and one of the world's leading CDMOs, specializing in integrated CMC services for small molecule APIs and drug products (oral and injectable/sterile) from preclinical to commercial scale. They also have capabilities in oligonucleotides, peptides, and bioconjugates. WuXi STA operates 9-14 global manufacturing sites across Asia, North America, and Europe with uniform quality/EHS standards approved by major regulators. They have supported 50+ first-time drug approvals since 2017 across 105 countries. The company has 5,100+ scientists, claims 100% PPQ success rate, and serves 1,200+ customers. Their Changzhou site has passed US FDA inspection and they have a continuous manufacturing line for oral solid dose.

Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.

ST Pharm is a South Korean global API CDMO company founded in 1983, specializing in small molecule APIs, oligonucleotide therapeutics (ASO, siRNA, aptamers), and mRNA-LNP manufacturing. The company operates cGMP manufacturing facilities in South Korea and has a CRO subsidiary (AnaPath) in Switzerland and Spain for preclinical pathology services.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Chinese pharmaceutical manufacturer specializing in corticosteroid, hormone, and steroid API production. Subsidiary of Shanghai Pharmaceuticals (Shanghai Xinyi Pharmaceutical Factory). Founded in 1992, located in Tianjin with approximately 170,000 sq meters across two factory areas and 507 employees. Main products include hydrocortisone, spironolactone, hydrocortisone acetate, clobetasol propionate, and related corticosteroid APIs. Also produces tablet formulations (9 approved products). Has 11 API production licenses and 9 tablet production licenses. FDA-registered with 3 FEI numbers, 13 inspections (4 NAI, 8 VAI, 1 OAI), and 2 FDA-approved finished dosage form products.

Wanbang Biopharmaceuticals is a Chinese pharmaceutical manufacturer based in Xuzhou, Jiangsu province, specializing in the development, manufacture, and sale of pharmaceutical products. The company has FDA registration and produces products including capsules and APIs such as Febuxostat and Apixaban.

Zambon is an Italian multinational healthcare group founded in 1906 with EUR 899 million in revenues and 2,768 employees. The group operates as both a pharmaceutical company (Zambon Pharma) and a CDMO, offering contract development and manufacturing services ranging from development through commercial production. Manufacturing plants in Vicenza (Italy), Cadempino (Switzerland), Haikou (China), and Barueri (Brazil) supply 87 countries. Also includes Zach System (API custom synthesis) as its chemical division.

Zhejiang Davi Pharmaceutical Co., Ltd., established in 2004, is an exclusively foreign-owned high-tech manufacturer of active pharmaceutical ingredients and intermediates located in Huzhou City, Zhejiang, China. With a total investment of $8M USD and 35,000 m2 floor space, they operate FDA and COS-required GMP workshops. They specialize in folate-related APIs: Methotrexate, Methotrexate Sodium, Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, and L-5-Methyltetrahydrofolate Calcium. The company is FDA-registered with 3 FEI numbers, has 8 FDA inspections (2 NAI, 6 VAI, 0 OAI), 1 Class II recall, 4 FDA-approved products (tablet, extended-release tablet), and participates at CPHI events globally. They undertake OEM orders for intermediates. Classified as API manufacturer rather than CDMO because they primarily manufacture their own specialty APIs; contract services appear limited to OEM intermediate orders.

Zhejiang Hisoar Pharmaceutical Co., Ltd. (stock code 002099, Shenzhen Exchange), founded in 1966 and headquartered in Taizhou, Zhejiang, China, is a diversified pharmaceutical and chemical company with ~3,000 employees and 426 R&D personnel. Their pharmaceutical division produces specialty APIs, intermediates, formulations, and fine chemicals -- specifically antibiotics (penem/carbapenem series, clindamycin series), cardiovascular agents, and anti-diabetic APIs. Over 70% of products are exported. They also have a major dye/pigment business segment (~70% global market share in Reactive Blue KN-R). The company has 3 FDA-registered FEI numbers for API manufacture, 7 FDA inspections (4 NAI, 3 VAI, 0 OAI), 2 FDA-approved products (capsule, tablet), 40+ invention patents, and partnerships with Boehringer Ingelheim, Merck, Sanofi, Novartis, GSK, and others. Classified as API manufacturer because the core pharma business is own-brand API and intermediate production with limited CDMO positioning, though PharmaSource lists them under CMO/CDMO.

Aurisco Pharmaceutical Co., Ltd. is a CRDMO (contract research, development and manufacturing organization) headquartered in Taizhou, Zhejiang, China, specializing in generic and complex APIs and finished dosage forms. The company focuses on small-molecule drugs, peptide therapeutics, and oligonucleotide pharmaceuticals. Aurisco operates 4 manufacturing sites and 5 R&D centers in China with 1,500+ staff, has passed 5 cGMP inspections in 2023 (USFDA, EUGMP, PMDA, NMPA, KFDA), and is expanding peptide manufacturing capacity. Their steroid product portfolio includes abiraterone acetate and complex hormone formulations.

Berko Pharmaceuticals is a Turkish pharmaceutical company involved in the development, manufacturing, and marketing of pharmaceutical products including solid dosage forms and suppositories. Listed on CPHI as a CDMO specializing in development and manufacturing, with FDA-registered facilities and a long track record of FDA-inspected production (2 NAI inspections). Also has 27 FDA recalls on record, indicating substantial US market supply history.

Chanelle Pharma is Ireland's largest indigenous pharmaceutical manufacturer producing both human health and veterinary products. The company operates 4 manufacturing facilities with 550 employees, holding 1,200+ human health licenses, and provides contract manufacturing services for B2B pharmaceutical customers. Chanelle Pharma was acquired by the private equity firm Exponent and has appointed a new CEO to drive international growth, with manufacturing plants in Ireland and near Rome, Italy.

Enteris BioPharma (now MOD3 Pharma, acquired by Aptar Pharma) was a US-based CDMO specializing in the development and manufacture of difficult-to-formulate oral drug products. Operating from a 32,000 sq ft FDA-inspected, cGMP-compliant facility in northern New Jersey, the company offered custom formulation development and clinical trial manufacturing services.

Guobang Pharmaceutical Group is a global pharmaceutical manufacturing company based in Zhejiang, China, and is among China's top 100 pharmaceutical enterprises. The company specializes in APIs, key pharmaceutical intermediates, and formulations for both human and veterinary health, with products sold to over 115 countries and regions. Founded in 1996, the company employs over 4,000 people across 2,500+ acres of operational land.

Hainan Shuangcheng Pharmaceuticals Co., Ltd. (HNSP) is a publicly-traded Chinese pharmaceutical company founded in 2000, engaged in R&D, manufacturing, and sales of pharmaceutical products with a focus on peptide APIs and injectable formulations. The company offers CDMO/contract manufacturing services representing 20-35% of revenue, and has FDA-registered facilities with multiple FDA inspection history. It operates manufacturing sites in Haikou and has invested in a Ningbo facility.

Hainan Zhonghe Pharmaceutical Co., Ltd., a subsidiary of Hainan Zhonghe (Group) Co., Ltd., is described as a leading high-tech pharmaceutical enterprise in Asia. The company manufactures pharmaceutical products including APIs and finished dosage forms such as Eptifibatide Injection, Entecavir Dispersible Tablets and Capsules, and Octreotide. It sells APIs and formulations through CPHI and other channels.

Halewood Laboratories Pvt. Ltd., established in 1984 in Ahmedabad, India, is a WHO GMP-certified contract manufacturing company specializing in pharmaceutical and food product manufacturing under loan license, third-party license, and private label arrangements. The company manufactures tablets, capsules, ORS products, effervescent tablets, energy drinks, and veterinary products, with exports to over 40 countries.

Huayi Pharmaceutical (Anhui) Co., Ltd. is an EU cGMP-approved Sino-British joint venture CDMO located in Hefei, Eastern China. The company specializes in contract development and manufacturing of high-quality generic pharmaceuticals across various dosage forms, offering integrated services from API production through finished dosage form manufacturing.

PiSA (Grupo PiSA / PiSA Farmaceutica) is a major Mexican pharmaceutical company manufacturing 1,500+ branded medications across 17 specialty lines in 14 production plants strategically located in Mexico. Employs approximately 30,000 workers. PiSA USA serves as the nearshore contract manufacturing arm, offering pharmaceutical and medical device CMO services. Company is a Socially Responsible Enterprise (ESR) for 15 consecutive years. Offers 'Maquila de Productos' (contract manufacturing) as a core service.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

Macleods Pharmaceuticals Ltd

India

Macleods Pharmaceuticals Ltd is one of India's top 10 pharmaceutical companies, operating as a CDMO for developing, manufacturing, and globally distributing pharmaceutical products. They produce diverse dosage forms including solid orals, liquid orals, topical formulations, injectables, metered dose inhalers, and dry powder inhalers across therapeutic areas including anti-TB, antimalarials, antiretrovirals, antidiabetics, antihypertensives, and antiasthmatics. They have 152 FDA-approved products, WHO prequalified medicines, and manufacturing facilities compliant with UK MHRA, US FDA, TGA, and WHO guidelines. They operate in 100+ countries.

OLIC (Thailand) Limited is one of the largest toll and contract manufacturers in Southeast Asia for branded pharmaceutical and healthcare products. The company is a subsidiary of Fuji Pharma and serves over 30 multinational companies including most Big Pharma organizations. OLIC's PIC/S-compliant manufacturing facility produces a wide range of dosage forms including sterile liquids, oral solids, semi-solids, and liquids, serving markets in Thailand, Southeast Asia, Japan, Australia, the US, and Europe.

Olive HealthCare is a fully-integrated Indian pharmaceutical company specializing in the development, manufacturing, and marketing of soft gelatin capsule formulations for pharmaceutical, OTC, and dietary supplement products. Operating three state-of-the-art manufacturing units in India, the company provides CDMO services including toll manufacturing and full development for global partners.

Oman Pharmaceutical Products Co. LLC is a pharmaceutical manufacturer based in Salalah, Oman, engaged in inhouse formulation manufacturing, out-licensing, and CDMO business. The company produces oral solid dosage forms including tablets and offers contract manufacturing services to partners in the region and beyond.

PHIL Inter Pharma is a CMO/CDMO operating two manufacturing sites in the same industrial park in Vietnam. The company is a soft capsule manufacturer offering CMO/CDMO services from a UK MHRA GMP-accredited facility for pharmaceuticals. PHIL Inter Pharma has 250-499 employees and also manufactures generics/biosimilars. Products include the KOSENA and CALEDO brands. The company has South Korean origins (KR) and a US presence (PHIL Inter Pharma USA). No website data was available for detailed analysis.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.

Ropack Pharma Solutions is a privately held CMO/CDMO based in Montreal, Canada, specializing in solid oral dose contract manufacturing and comprehensive packaging services. With nearly 50 years of experience, the company provides drug development, tech transfer, clinical and commercial manufacturing, and serialized packaging services for solid oral dosage forms.

Savi Pharmaceutical Joint Stock Company (Savipharm J.S.C, SVP) is a Vietnamese pharmaceutical company founded in 2005 in Ho Chi Minh City. The company operates an oral solid dose factory and provides contract manufacturing of dosage form drugs, franchising, and technology transfer services.

Sovereign Pharmaceuticals, LLC is a U.S.-based CDMO located in Fort Worth, Texas, specializing in small-batch prescription drugs. The company packages both solid and liquid pharmaceutical products and has a high potency pharma suite. Sovereign has over 30 years of expertise and was acquired through bankruptcy proceedings by Alora Pharmaceuticals.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Syncom Healthcare Ltd is an Indian pharmaceutical manufacturing company headquartered in Indore, Madhya Pradesh, with approximately 235 employees. The company's website domain has been sold, suggesting the company may be defunct or restructured. Search results reference the company as a drug manufacturer that has faced quality issues including a dissolution failure flagged by drug control authorities. Limited verifiable information is available about current operations.

Tirupati Group is one of India's largest contract development and manufacturing organizations (CDMOs), providing end-to-end solutions across pharmaceuticals, nutraceuticals, Ayurveda, and sports nutrition. Founded in 2005, the company operates state-of-the-art manufacturing facilities in Paonta Sahib (Himachal Pradesh) and Noida (Uttar Pradesh), serving 350+ clients including Abbott, Pfizer, Dr. Reddy's, and Sun Pharma.

Zhejiang Langhua Pharmaceutical Co., Ltd. is a comprehensive CDMO subsidiary of Viva Biotech Holdings, specializing in small molecule contract development and manufacturing. Viva Biotech acquired Langhua for RMB 2,560 million ($368M) to build out their CDMO service chain capabilities. Langhua offers CMC development, API synthesis, and formulation services from pre-clinical through commercial scale. They have completed numerous CDMO cases and have a subsidiary Ningbo Nuobai Pharmaceutical for additional capacity. The company is FDA-registered (FEI 3005289386) and has passed an FDA on-site cGMP inspection, with 3 total FDA inspections (1 NAI, 2 VAI, 0 OAI). They market themselves explicitly as a CDMO offering end-to-end services from CMC through API to formulation manufacturing. No website text was available (empty), so classification relies on search results and regulatory data.

Alfasigma (Morpho CDMO)

Italy

Alfasigma operates a CDMO division (Morpho CDMO) based in Italy. No website content was available for detailed capability extraction, but the company is listed with a dedicated CDMO URL suggesting contract development and manufacturing services.

Corning Incorporated (Life Sciences & Pharmaceutical Technologies)

India

Corning Incorporated's Pharmaceutical Technologies division manufactures advanced glass packaging solutions for the pharmaceutical industry, most notably Valor Glass vials and containers designed for drug storage and delivery. The company is a materials science and glass technology company, not a drug manufacturer or CDMO.

CSL (incl. CSL Behring)

Australia

CSL is a global biotechnology company headquartered in Melbourne, Australia, operating through CSL Behring, CSL Seqirus, and CSL Vifor. The company specializes in plasma-derived biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies, vaccines, and iron deficiency treatments, but operates as an integrated developer/manufacturer for its own products rather than as a CDMO offering contract services to external clients.

DWK Life Sciences

Germany

DWK Life Sciences is a German company that manufactures laboratory glassware, tubular glass container closure systems (CCS), and packaging solutions for the pharmaceutical and life sciences industries. Through its subsidiary Mueller + Mueller, it provides pharmaceutical packaging solutions. It is a glass and labware supplier, not a drug manufacturer.

EMA Pharmaceuticals (Ema Pharma)

France

EMA Pharmaceuticals (Ema Pharma) is a French manufacturer of overseals (crimping capsules) for injectable pharmaceutical applications. The company specializes in sealing solutions for vials used in pharmaceutical injectable products, manufactured in a GMP-compliant facility. Note: The FDA regulatory data (90 approved products, 184 recalls) appears to be associated with a different entity sharing the FEI registrations, not the French crimp cap manufacturer.

HEC (HEC Pharm / Sunshine Lake Pharma)

China

HEC Pharm (also known as Sunshine Lake Pharma or Guangdong HEC Pharma) is a Chinese integrated pharmaceutical company established in 2003, focused on drug R&D, production, and commercialization of innovative drugs, generics, and biosimilars. The company specializes in anti-infection (oseltamivir) and chronic disease therapeutic areas with over 6,000 employees and 100+ R&D projects.