Apeloa-Services-FDF

About FDF

Apeloa adheres to the business development strategy of "making better FDF" by taking clinical value and market value as the guide, taking advantage of vertically integrated supply chain, and relying on the platform of FDFtechnology with high technical barriers.

The company's products involve anti-infectives, cardiovascular, oncology, central nervous system and TCM; Leading products include Cefixime series, Metoprolol Succinate ER Tablets，Bupropion HCL XL Tablets，Ubenimex capsules, Flucloxacillin sodium for injection, Levetiracetam tablets, Adamantium hydrochloride tablets, Levofloxacin tablets, Scutellariae granules, etc. .

The company has established a "diversified portfolio" strategy for its FDFbusiness, with 50+ projects in the pipeline, covering a wide range of areas such as anti-infective and anti-viral, cardiovascular, central nervous system, respiratory and digestion system.

120 ⁺

Number of products FDF
15

Products passed GCE

Apeloa owns two FDF manufacturing bases, with production lines for oral solid dosage, injection, oral suspension/oral solution, small aqueous injection, sterile powder for injection, ointment and so on.

The FDF manufacturing facility has established intelligent GMP management systems that are suitable for drug production, such as MES, WMS, LIMS, etc., and is equipped with world-class production equipment. One of the oral solid dosage workshop has a floor area of 26,000 square meters, a clean area of 10,000 square meters, and an annual production capacity of 3 billion tablets/capsules, which has successfully passed on-site inspections by NMPA, WHO, and USFDA.

Construction of new workshops will be started soon,covering OSD, PFS, Freezing drying etc，to fullfill the continuously increasing capacity demand from Customers and own products.

R & D

Established in June 2018, Hangzhou Apeloa Research Institute Co. Ltd. is the drug preparation research and development platform of Apeloa Pharmaceuticals Co. Ltd. Located in the Medicine Port Town of Qiantang District, Hangzhou City.

FollowsApeloa's strategy of "making better FDF" and the development strategy of "multi-product" FDFs, It focuses on independent intellectual property product innovation, building a competitive R&D system.

Utilizing the advantage of "integration of raw materials and FDF" of Apeloa, the company has built and established diversified FDF development platforms with high technological barriers, such as controlled release FDFs, non-homogeneous liquid FDFs,  taste masking technology and digital preparation process.

2700 m²

Laboratory Area
90 ⁺

R&D Staff
60 %⁺

PhDs, Masters and Senior Staff
50 ⁺

Projects in Progress
30 ⁺

Domestic and Foreign Production Approvals

DP Technology Platforms

Can Undertake Full Processes of Drug Research and Development

Project Evaluation
FDF Process Study
Analytical Method Development & Quality Standardization
Clinical Bioequivalence Study
Registration Filing

The Institute focuses on building a differentiated product development pipeline based on clinical and market value; Equipped with internationally advanced FDFresearch and development equipments and instruments Product declaration area covers all major markets in the world, including China, the United States, Europe and WHO.

R & D equipment mainly include: high shear wet granulation machine、Alexanderwerk dry granulator, multifunctional fluidised bed, double-layer tablet press, high-efficiency coating machine, Telstar lyophiliser, air-flow pulveriser, etc;

R&D instruments include: High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Inductively Coupled Plasma-Mass Spectrometer (ICP-MS), Ultra Performance Liquid Chromatograph (UPLC), Dissolution Meter, Mastersizer 3000 Laser Particle Sizer, Differential Scanning Calorimeter (DSC), Dynamic Moisture Sorption (DVS), TMS Texture Meter, INSENT Taste Analysis System, etc;

The dosage forms under development: immediate-release, enteric-coated, extended-release tablets, minitabs, bilayer tablets, dispersible tablets, dry suspension, granules, solution, small aqueous injections and lyophilised powder injections;

It covers therapeutic areas such as psychiatric, anti-infective, cardiovascular and cerebrovascular.