SINOWAY INDUSTRIAL CO., LTD

SINOWAY INDUSTRIAL CO., LTD

One-stop CDMO Solutions for APl and Key intermediates

About the plant

Sinoway Industrial Co., Ltd. was established in China in 1987, and now has grown as a leading company specializing in exporting, custom development and manufacturing of APIs, pharmaceutical intermediates, food supplement ingredients, cosmetic raw materials (including peptide series, prostaglandin series, plant extracts, etc.) and pharmaceutical packaging products, including packaging for cold chain, metered-dose inhalation aerosol, etc.

Sinoway has passed ISO9001:2015 and SGS audit to ensure the quality of products and services meet international standards and customers’ requirements.

Sinoway also can provide one-stop CDMO service from R&D to production, especially for custom development and manufacturing of advanced intermediates and new compounds with special high-quality requirements after signing secret agreements.

Sinoway has established long-term cooperation with China’s top analysis & testing centers, institutes and universities, which are equipped with various facilities for special chemical reactions and testing conditions, including HPLC, LC-MS, GC, GCMS, UV, etc., to provide various testing services for products throughout the entire product development cycle.

Additionally, Sinoway cooperates closely with Chinese factories, which have advanced production equipment and experts with rich experience in organic chemistry, enzyme catalysis, fermentation processes, etc. They strictly comply with both Chinese and international GMP regulations and ICH Q7 quality management specification.

Sinoway has a professional sales team with rich experience in products and markets. Since 1992, Sinoway has participated in healthcare exhibitions every year, such as CPhI Worldwide, CPhI Japan, CPhI China, and Supply Side West in the USA. Sinoway has established long-term business relationships with customers from the USA, Canada, Japan, South Korea, Switzerland, Germany, Hong Kong, and others for over 30 years. Sinoway is a reliable supplier of the world’s leading pharmaceutical companies, such as Novartis, TEVA, Daito, and Sumitomo Seika. Besides, Sinoway is the China office of FISCHER Chemical A.G, responsible for project and supply chain services.

“Integrity, Dedication, Gratitude, Innovation, Diligence” are the core values of Sinoway. The company will keep devoting itself to the supply of custom development & manufacturing of high-quality products with competitive prices, aiming to create sustainable values for customers, shareholders, and employees, and to maximize value for all customers with high-quality products and professional service, to become one of the leading suppliers in the big-health industry.

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Certifications

• ISO
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• SQF (Safe Quality Food)
• Halal Research Council

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Activity

• Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Human / animal extracted products, ATMP (Advanced Therapies), pDNA, gRNA, Minicircle DNA, mRNA, Implants, Inhalation products, Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Aerosol, Powder, Nebulization, Bottles, Sprays, Sachets, Ampoules, Oral solutions, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Lyophilizates, Lozenges, Gummies, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Bottles, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampolues, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, COSMETICS, NUTRACEUTICALS, OLIGONUCLEOTIDES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients), Excipients, Skin products, Hair and scalp care products, Products for nails and cuticles, Skin care, Skin cleansing, Hair removal, Hair bleaching, Correction of body odor or perspiration, Shaving, pre-shave and after-shave, Make-up, Perfumes, Sun protection and self-tanning, Other skin care products, Hair and scalp care and cleansing, Other hair and scalp care products, Loose powder, Liquid, Tablets, Granules / Pellets, Powders, Lyophilizates, Solutions, Vials, ASOs (Antisense oligonucleotides), siRNA, miRNA, Aptamers, PMOs, CpG ODNs, gRNA manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
• DEA: Schedule III (lower potential for abuse)
• BSL: 1, 2, 3, 4
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens
• Markets: NMPA (China)

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Batch Size / Reactor

• Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L, > 5000 L, 1 - 10 sqm, 10 - 50 sqm, 50 - 100 sqm, 100 - 200 sqm, > 200 sqm, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L

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Services

• Development services, Manufacturing services, R&D, Fill&Finish, Sterile product manufacturing, Non sterile product manufacturing, Pilot plant, Formulation mixing, Lyophilization, Scale-up, Pilot batches, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, OSD (Oral Solid Doses) manufacturing, Fill and finish, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis, Samples manufacturing

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