Manufacturer of injection and ophthalmic solutions in PP bottles, plastic and glass ampoules for the MENA region
Advanced Pharmaceutical Manufacturing Co. Ltd. (BPharma)
Jeddah, Saudi ArabiaNew on Amplifa
About BPharma
BPharma (Advanced Pharmaceutical Manufacturing Co. Ltd.) is a pharmaceutical manufacturer located in Jeddah, Saudi Arabia. The company produces injection and ophthalmic solutions in six dosage forms: PP bottles, Plastic Vials, Plastic Ampules, Minims, Glass Ampules and Glass Vials. The portfolio comprises 118 products from eight therapeutic areas, including electrolytes and IV fluids, pain management, anti-infectives, anesthetics and ophthalmology. Manufacturing is carried out in accordance with international GMP standards, oriented toward EU-GMP and EU-DRALEX requirements. In addition to manufacturing its own products, BPharma offers contract manufacturing (CMO) for national and international partners, secondary packaging with serialization and aggregation, quality control as well as research and development services. The Flexi-Clear technology based on polypropylene granulate enables terminal sterilization at 121 °C and high clarity for visual inspection.
- Site
- Jeddah
- Processes
- Pharmaceutical manufacturing of injection and ophthalmic solutions (IV solutions, glass ampoules), Terminal sterilization at 121°C (Flexi Clear PP bottles), Contract Manufacturing (CMO) according to international GMP standards, Secondary packaging services (fully automated visual inspection, pick-and-place robotics), Quality control / analytical testing of raw materials, packaging materials, in-process samples and, R&D Services: formulation development, process optimization, scale-up, technology transfer, Manufacturing of dosage forms: PP Bottles, Plastic Vials, Plastic Ampules, Minims, Glass, Contract Manufacturing (CMO)
- Materials
- Polypropylene (PP) granulate (Flexi Clear, terminal sterilizable up to 121°C), Glass (ampoules/vials), Polypropylene (PP) granulate, Glass
- Certificates
- EU-GMP, EU-DRALEX, ISO 9001
- Industries
- Pharmaceutical industry, Healthcare facilities, MENA region, CMO/CDMO partners
- 01
R&D and formulation development
- 02
Pharmaceutical manufacturing (injectables/ophthalmics)
- 03
Terminal sterilization (Flexi Clear, 121 °C)
- 04
Quality control
- 05
Secondary packaging with serialization/aggregation
- 06
Batch release (SFDA-compliant)
Materials & Processes
Polypropylene (PP) granulate
Flexi-Clear bottles with high clarity, terminal sterilizable at 121 °C.
Glass
Used for Glass Ampules and Glass Vials.
Locations
Jeddah
SAProduction site (manufacturing of injectables/ophthalmics), QC laboratories, secondary packaging, R&D
- Materials
- Polypropylene (PP), Glass
- HPLC
- UV-visible spectrophotometer
- Polarimeter
- TOC analyzer
- Auto titrators
- LBPC (PMS)
- Ovens & incubators
- Autoclaves
- VITEK system
- BET testing equipment
- Fully automated visual inspection systems
- Pick-and-place robotics
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Pharmaceutical manufacturing of injection and ophthalmic solutions (IV solutions, glass ampoules)Pharmaceutical manufacturing | – | – | – | – | Polypropylene (PP) granulate, Glass |
| Terminal sterilization at 121°C (Flexi Clear PP bottles)Pharmaceutical manufacturing | – | – | – | – | Polypropylene (PP) |
| Contract Manufacturing (CMO) according to international GMP standardsPharmaceutical manufacturing | – | – | – | – | – |
| Secondary packaging services (fully automated visual inspection, pick-and-place robotics)Assembly | – | – | – | – | – |
| Quality control / analytical testing of raw materials, packaging materials, in-process samples andTesting | – | – | – | – | – |
| R&D Services: formulation development, process optimization, scale-up, technology transferEngineering | – | – | – | – | – |
| Manufacturing of dosage forms: PP Bottles, Plastic Vials, Plastic Ampules, Minims, GlassPharmaceutical manufacturing | – | – | – | – | Polypropylene (PP) granulate, Glass |
12 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| HPLC | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| UV-visible spectrophotometer | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| Polarimeter | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| TOC analyzer | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| Auto titrators | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| LBPC (PMS) | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| Ovens & incubators | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| Autoclaves | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| VITEK system | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| BET testing equipment | – | – | – | – | Jeddah, Saudi Arabia (QC laboratory) |
| Fully automated visual inspection systems | – | – | – | – | Jeddah, Saudi Arabia (Secondary Packaging) |
| Pick-and-place robotics | – | – | – | – | Jeddah, Saudi Arabia (Secondary Packaging) |
Additional services
Quality
Quality control is carried out in chemical and microbiological laboratories with instruments such as HPLC, UV-Vis spectrophotometer, TOC analyzer, VITEK system and BET testing equipment; raw materials, packaging materials, in-process samples and finished products are tested according to international standards.
| Evidence | Jeddah |
|---|---|
| EU-GMP | |
| EU-DRALEX | |
| ISO 9001 |