Lyophilization CDMOs

Jubilant HollisterStier CMO

Canada

Jubilant HollisterStier CMO (subsidiary of Jubilant Pharma) specializes in sterile fill-finish, lyophilization, injectables, ophthalmics, otics, topicals, and liquids for pharmaceutical and biopharmaceutical clients. End-to-end services from process development to inspection and packaging. Facilities in Spokane, WA and Montreal, QC. Won AWB Manufacturer of the Year 2024 and Manufacturing Excellence Award 2025. Largest manufacturer by employees in Spokane area. 92% repeat customer rate. FDA registered with 4 FEI numbers, 28 inspections (6 NAI, 18 VAI, 4 OAI -- elevated regulatory risk).

Latitude Pharmaceuticals Inc

United States

Latitude Pharmaceuticals Inc is a San Diego, CA-based CRO/CMO (CRDMO) providing innovative drug formulation development and GMP manufacturing services. Founded in 2003, the company has completed over 900 pharmaceutical formulation development projects for 250+ client companies. Specializes in solving complex drug formulation challenges, particularly for insoluble APIs using their proprietary CLEARSOL platform. Provides GLP- and GMP-compliant manufacturing and analytical testing services for IND-enabling studies and Phase 1-2 clinical trial materials, including sterile injectables, fill/finish, lyophilization, vials, pre-filled syringes, and IV bags.

Lupin Limited (Lupin Manufacturing Solutions)

Brazil

Lupin Manufacturing Solutions (LMS) is the CDMO arm of Lupin Limited, one of India's largest pharmaceutical companies. LMS offers integrated CDMO services spanning API manufacturing, formulation development, and finished dosage form production. They operate 16 FDA-registered facilities with 512 FDA-approved products. They have recently expanded into oncology with a dedicated block at Vizag, India, and formed a strategic alliance with PolyPeptide for peptide supply chain scaling. Their extensive regulatory track record includes FDA, WHO, and multiple international approvals.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

PharmIdea is a Latvian CDMO located in Olaine, Latvia, specializing in sterile drug development, commercial production, and worldwide supply of pharmaceutical products. The company focuses on sterile drugs in vials, offering contract manufacturing services including product development. PharmIdea has completed CTDs for out-licensing and provides contract manufacturing of sterile injectables such as Levosimendan concentrate for solution for infusion (small batch), Caspofungin, and Carbetocin. The company has partnered with Lidds for manufacturing NZ-TLR9 formulation against solid tumors.

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.

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.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Kaisha Lifesciences Pvt. Ltd

India

Kaisha Lifesciences is a pharmaceutical company under the Dadachanji Group of Companies (30+ year heritage), offering contract R&D services from product development to scale-up, plus its own product portfolio. Part of a diversified group including Schott Kaisha (glass vials, 50% acquired by Serum Institute of India), Kaisha Packaging, and Kaisha Medisurge. WHO-GMP certified manufacturing facility for terminally sterilized and aseptically filled injectables in ampoules, vials (liquid and lyophilized), and pre-filled syringes. Departments include formulation development, analytical development, quality assurance, and regulatory affairs. Products include Enoxaparin Sodium Injection. First Indian patent approval 2021.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

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.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

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.

Nectar Lifesciences Ltd.

India

Indian pharmaceutical company with vertically integrated API and formulation manufacturing. FDA registered with 2 FEI numbers (operations: ANALYSIS, API, FDF). Offers CDMO services alongside own branded products. Manufactures both APIs (including beta-lactam antibiotics) and finished dosage forms across oral solids, injectables, and lyophilized products.

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.

Reig Jofre (Laboratorio Reig Jofre, S.A.) is a Spanish pharmaceutical company founded in 1929 that operates both as a pharmaceutical company with its own products and as a CDMO. They have four development and production centres in Europe (two in Toledo, one in Barcelona, one in Sweden) with over 1,100 employees. Their CDMO capabilities include sterile lyophilizates, sterile liquids, non-sterile liquids, and beta-lactam manufacturing. Known for excellence in freeze-drying technology and advanced sterile manufacturing. FDA-registered with manufacturing and analysis operations, though regulatory history shows 3 OAI inspections.

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.

Cilian AG is an innovative German biotechnology company based in Munster that uses ciliates as a novel class of production organisms for industrial protein production. The company has collaborated on recombinant influenza vaccines and received investment from Lonza, operating as a platform technology company rather than a contract drug manufacturer.

Lyomark Pharma GmbH

Germany

Lyomark Pharma GmbH is a German CDMO specializing in sterile medicinal products. They organize contract manufacturing based on dossiers they compile and maintain, and offer regulatory services. Through their subsidiary Lyocontract, they operate a state-of-the-art pharmaceutical manufacturing site. They have 39 FDA-approved products across injectable, oral solid, and liquid dosage forms. The company focuses on niche indications for the hospital market with global distribution.

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.

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).

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).

Lyophilization Technology, Inc. (LTI)

United States

Lyophilization Technology, Inc. (LTI) is a US-based CDMO focused on lyophilization (freeze-drying) development and sterile clinical supply manufacturing. They offer development sciences (formulation development, thermal analysis, cycle design, product characterization, pilot plant scale-up), clinical manufacturing (Phase I, II, and toxicology), and technical services. They have specialized capabilities in dual chamber cartridges and syringes, and isolation/containment for potent compounds.

Pytri Inc.

Canada

Pytri Inc. is a Canadian company with a JavaScript-only website that provides no readable content. Search results do not return relevant information about Pytri specifically -- results are contaminated with Pyramid Pharma Services and TriRx Pharmaceuticals content. Insufficient evidence to classify this company or assign any capabilities.

LucasPye BIO (LPB) is a US-based CDMO focused on accelerating biotherapeutic innovation. They offer comprehensive biopharmaceutical development and manufacturing solutions including cell line development, upstream/downstream process development, and cGMP manufacturing of biologics. They aim to bring down CDMO costs through strategic vendor partnerships to make biotherapeutics more affordable.