|
NDDS (Novel Drug Delivery System):
With the goal of building and positioning Sidmak as a research-based pharmaceutical company, with special focus on NDDS, we carry out extensive research in the field of NDDS not only at the technical level but also at the administrative level to make the quality product affordable for our esteemed
customers.
Driven by a team of enthusiastic and bright young scientists, Sidmak’s current focus in NDDS is in the area of oral-modified release-systems. Our team has successfully developed oral modified release systems for a number of drugs. We have developed extensive in-house R&D facility. We are always looking forward for joint research in India / abroad as and when the opportunity generates.
Pharmaceutical Research:
Pharmaceutical Research, an integral part of R&D, comprising of product, packaging and process development departments, is responsible for dosage form development complying to regulatory requirements.
The pharmaceutical development activity allows Sidmak to develop a wide range of dosage forms and value added line extensions such as:
Solids - Tablets, Capsules Tablets- Sugar/film coated including delayed release – uncoated, dispersible, mouth dissolving tablets, effervescent tablets
Capsules- soft/hard gelatin
Packaging Development:
Selection, design and development of novel packaging systems for international marketing.
Process Development:
Facilities exist to transfer technology from lab to pilot plant to manufacturing locations worldwide.
Analytical Research:
The Analytical Research focuses on optimistic quality for Sidmak Products. Its objective is to provide timely, cost effective, validated analytical services for research, enabling Sidmak to meet international quality and regulatory requirements.
The Analytical Research is carried out using Sophisticated Instruments. To mention a very few of them we have
-
High Performance Liquid Chromatography (HPLC)
-
Gas Chromatography (GC)
-
Liquid Chromatography-Mass Spectroscopy
-
Fourier Transform Infra Red Spectroscopy (FT-IR)
-
Atomic Absorption Spectrometer
The function is engaged in:
-
Method Development for Pharmaceutical Substances, Dosage Forms and Degradation Products /Related Substances
-
Method Validation
-
Quality Control
-
Shelf-Life/Stability Studies
-
Specifications/Standard Testing Procedures
-
Quality Awareness Programmes
-
GMP/GLP Compliance
Regulatory Affairs:
Sidmak’s Regulatory Affairs function is responsible for handling different types of registrations for dosage forms including oral controlled drug delivery systems.
Quality Assurance:
The Quality Assurance is responsible for maintenance of highest level of compliance at Sidmak manufacturing unit. In ensuring the compliance to cGMPs, it helps Sidmak carve out a niche for itself in terms of Quality, in globally competitive pharmaceutical market. The Quality
Assurance, working in consonance with it's manufacturing unit, gears for various regulatory inspections. Sidmak is in the process of getting MCA approval.
The Quality Assurance plays a leading role in Quality Management in Sidmak - an effort to identify and nourish the right things - people, processes and practices. It
benchmarks best quality practices, performs self-assessment and steers the units to achieve the best Quality.
Major Activities of QA:
Periodic audit of Manufacturing facilities: To ensure that product purity, integrity and safety is maintained.
Audit of suppliers of critical raw materials: Thus ensuring that input raw materials have the desired purity & integrity.
Interfaces in Technology Transfer activity: By ensuring that the development work at R&D are in compliance to GMP requirements and the manufacturing units receive an accurate process package.
Markets Surveillance & Bench Marking studies: To set goals to meet the quality requirements, internationally.
Statistical Process Controls: Conducts studies to reduce any wide variation in products quality.
| 
