Formulation Services
Finished Dosage Form (FDF) Formulation Services | Oral Solid Dosage Forms
Formulation
Finished Dosage Form (FDF)
Since its founding in 2004, Sinopep has built a robust and scalable formulation platform dedicated to delivering high-quality pharmaceutical products and CDMO solutions. With a strong foundation in innovation and regulatory compliance, Sinopep has evolved into a trusted partner for both oral and injectable dosage forms.
Our state-of-the-art formulation facilities offer advanced production capabilities:
Oral Solid Dosage Forms (Workshop 201):
- Tablets: 270 million units/year
- Hard Capsules: 290 million units/year
- Granules: 13 million bags/year
Injection Production (Workshop 202):
- Lyophilized Powder Injections: 5.6 million vials/year
- Small-Volume Injections (Penicillin bottles): 13.8 million vials/year
- Non-sterile preparations also supported
From the launch of our first self-developed product, Thymalfasin for Injection, to the continuous expansion of our “China Pharma Port” campus, we have grown into a vertically integrated organization with comprehensive R&D, manufacturing, and packaging capabilities. Our facilities are built to meet international standards (FDA & EMA compliant), and we are proud to support a growing portfolio of CDMO projects across various dosage forms.
Milestones of Growth and Excellence:
- 2021–2022: National-level procurement success with Thymalfasin and Oseltamivir Phosphate Capsules; delivery of first CDMO projects.
- 2023–2024: Expanded manufacturing footprint, with multiple workshops (203, 205, 210, 211) achieving GMP validation. Over 40+ pipeline and regulatory-stage products are in progress.
- 2025: New GMP-validated facilities (206/209) reinforce our capacity for high-quality, large-scale production.
Sinopep is positioned at the forefront of international pharmaceutical innovation and manufacturing excellence—your ideal partner for bringing complex formulations to market efficiently and reliably.
Formulation Services Video
A closer look at our state-of-the-art new Formulation Facility
Sinopep has developed a robust and scalable formulation platform focused on delivering high-quality pharmaceutical products and CDMO solutions. Our recently expanded formulation facility provides even greater production capacity and an expanded range of services for our clients. From early development through commercial manufacturing, Sinopep offers end-to-end formulation services—including granulation, tableting, film coating, aseptic filling, and lyophilization—helping clients efficiently bring complex formulations from clinic to market.
Injection Dosage
Injection Formulation
Applicable Processes & Packaging
We offer full-scale sterile manufacturing with aseptic filling, lyophilization, terminal sterilization, and prefilled syringe/vial/cartridge lines. Applicable processes include solution preparation, filtration, filling (liquid & lyophilized), and visual inspection. Packaging options: vials, prefilled syringes, cartridges, and ampoules.
Applicable Process
| Service | Container | Supported Formats |
|---|---|---|
| Aseptic Filling | Prefilled Syringe | Non-terminal & terminally sterilized small-volume injections |
| Aseptic Filling | Cartridge | Non-terminal sterilized small-volume injections |
| Aseptic Filling | Vial | Lyophilized powder injections. Non-terminal sterilized injections |
| Aseptic Sealing | Glass Ampoule | Non-terminal & terminally sterilized small-volume injections |
Packaging
| Aseptic Filling | Filling Volume | Min. Prep Volume | Max. Prep Volume |
|---|---|---|---|
| Prefilled Syringe | 0.5 – 5 ml | 12 L | 500 L |
| Cartridge | 0.5 – 3 ml | 25 L | 1200 L |
| Vial | 0.5 – 10 ml | 12 L | 500 L |
| Glass Ampoule | 0.5 – 10 ml | 12 L | 500 L |
Oral Solid Dosage
Solid Dosage
| Facility | Dosage Form | Annual Production Capacity | Batch Range | Workshop Status |
|---|---|---|---|---|
| 203 Workshop | Oral Solid Dosage (Workshop 1) |
|
45–300M tablets/capsules or 45–600 kg |
|
Applicable Processes & Packaging
Our oral solid dose formulation services provide end-to-end capabilities from API pre-treatment to finished packaging, featuring hammer, jet, and cone milling, wet and one-step granulation ranging from 200 to 640 liters, dry granulation at 50 to 100 kg per hour, bottom-spray pellet coating from 80 to 384 liters, high-shear mixing from 300 to 1500 liters, tableting for single or double-layer tablets, and film coating from 90 to 350 kg. The applicable packaging options include Alu-PVC, Alu-Alu, and Alu-PVC-Alu blisters, strip bags, four-side sealed sachets with equipment arriving soon, and glass bottles for granules or dry suspensions.
Packaging
| Packaging Type | Description / Materials |
|---|---|
| Blister Packs | Alu-PVC • Alu-Alu • Alu-PVC Alu (cold-formable multilayer) |
| Four-Side Sealed Sachets | Small bags (4-side seal) |
| Strip Packs | Strip Bags Packaging |
| Glass Bottles | Dry Suspension / Granules |
Equipment
| Milling & Size Reduction | Granulation & Processing | Formulation, Packaging & Facility |
|---|---|---|
| Hammer Mill Jet Pulverizer |
Wet and Dry Granulation Lines Blenders |
Tablet Press Coating Machine Capsule Filling Machine Four-side Sealed Small Bag Machine Granule Bottle Filling Line Alu-PVC/Alu-Alu Packaging Line Elevators |
Applicable Process
| Process | Details / Type | Capacity |
|---|---|---|
| Pre-treatment | Hammer Milling, Jet Milling, Cone Milling, Swing Granulation, Vibrating Screen, etc. | — |
| One-step Granulation | Fluid bed processor | 200 L – 600 L |
| Wet Granulation | High-shear granulator fluid bed dryer | 200 L – 640 L |
| Pellet Coating | Bottom-spray Wurster coating | 80 L – 384 L |
| Dry Granulation | Roller compaction | 50–100 kg/h (equipment pending) |
| Filling | Granules, Powder, Pellet | — |
| Tableting | Direct compression, Granule tableting, Single/Double-layer tablets | — |
| Mixing | Bin blending / High-shear mixing | 300 L – 1500 L |
| Film Coating | Perforated pan coating | 90 kg – 350 kg |
