Pharmaceutical Development Centre (PDC)
PDC - core proficiency and we carry out the development of generic formulations and over the counter (OTC) formulations.
The intended product attributes are zeroed down upon and the prototype formulations are developed to meet the desired product attributes. Based on the formula and process optimization studies, the final composition and manufacturing process is recommended for scale-up.
Hamlai Industries Pvt. Ltd believes QbD i.e. Quality by Design (ICHQ8) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Hamlai Industries experts have applied this approach to product development and can offer their expertise to facilitate dossier submission and registration.
Formulation Development
- Pre-formulation Study (Solubility & Drug-Excipient compatibility etc.)
- Formulation Development
- Troubleshooting and process development
- Lab-scale stability evaluation
- Process optimization
- Scale-up / Technology transfer
Can develop and design the formulation & Process -
- Oral solids dosage forms( Tablet, capsule & Pellet)– High and Low shear Process, Wurster Process, Dry Mix & Direct Compression Process
- Oral liquids- Syrup/Emulsion/Suspension
- Topical (Ointment, Cream, Gel)
Analytical Development
The analytical development laboratory provides complete analytical service support (for drug substances and drug products) including:
- Method verification
- Method optimization
- Method development
- Method validation
- Pre-formulation study support, such as forced degradation/compatibility studies
The infrastructure comprises of state of an art facility with the most modern equipment’s including HPLC, GC, UV, FTIR, Dissolution apparatus, stability chambers, and networking software to mention a few.
Packaging Development
Core proficiency and we routinely carry out packaging development activity of generic formulations and over the-counter (OTC) formulations.
The intended product packaging developments are worked out and the prototype pack is developed to meet the desired product attributes. Based on the studies, the final primary packing composition and packing process are recommended for scale-up
Activities include.
- Primary packing material compatibility studies
- Packaging Development
- Lab-scale stability study packing activity & evaluation.
- Scale-up / Technology transfer.
Pharmaceutical Testing Laboratory (PTL)
Public Testing Laboratory is currently approved by Indian FDA (Gujarat) and Ministry of Health (MOH), The Sultanate of Oman, and also audited and approved by the EU authorities in April 2022.
Our testing procedures are fully compliant with cGMP norms and are regularly upgraded to meet new stipulations.
The infrastructure comprises of state of an art facility with the most modern equipment including HPLC, GC, UV, FTIR, Dissolution apparatus, stability chambers, and networking software connected to each qualified instrument.
In PTL, we provide the services of Raw materials & Finished Goods Testing as per defined and respective specification and also Stability Study & stability Sample testing.