Sustainability is embedded in every stage of our drug development process. From discovery to commercialization, we implement green chemistry principles and sustainable manufacturing practices.

⦁ Formulation Services –

NCE, Differentiated/ 505B2,
Generics, Complex generics, OTC, Veterinary

⦁ Analytical Services –

Method Development/ Testing
Method Verification/ Validation
API & WS qualifications
Method Transfer
ICH Stability Studies
RLD Reverse Engineering
Pre-formulation
Identification & Characterization of Impurities
Pharmaceutical equivalence studies / Multimedia dissolution

⦁ Standalone Services -

Method development
Method validation
Testing services
Reverse engineering of reference product
Pharmaceutical equivalence
Tech Transfer
⦁ Formulation development encompasses a wide range of activities aimed at creating a stable, effective, and manufacturable pharmaceutical product. The key areas typically covered include:

1. Pre-Formulation Studies

⦁ Physicochemical Properties:
Assessment of solubility, pH, polymorphism, particle size, and stability.

⦁ Compatibility Studies:
Interaction between active pharmaceutical ingredients (API) and excipients.

⦁ API Characterization:
Evaluation of properties like hygroscopicity and degradation pathways.

2. Formulation Design⦁ Dosage Form Selection:
Solid (tablets, capsules), liquid (solutions, suspensions), semisolid (gels, creams), or parenteral.

⦁ Excipients Selection:
Choosing stabilizers, fillers, binders, and other functional components.

⦁ Process Optimization:
Selection of manufacturing techniques like granulation, direct compression, or lyophilization.

3. Prototype Development and Optimization

⦁ Experimental Batches:
Development of initial formulations for evaluation.

⦁ Optimization:
Refining formulations using statistical tools (e.g., DOE).

4. Analytical and Stability Testing

⦁ Stability Studies:
Short-term and long-term testing under ICH guidelines to ensure product consistency.

⦁ Dissolution and Bioavailability Studies:
Ensuring release profiles align with therapeutic needs.

⦁ Quality Control:
Defining critical quality attributes (CQAs) and process parameters (CPPs).

5. Scale-Up and Technology Transfer

⦁ Manufacturability Assessment:
Ensuring the formulation can be scaled for commercial production.

⦁ Tech Transfer:
Transitioning processes to production facilities.

6. Regulatory Compliance

⦁ Documentation:
Preparation of required regulatory submissions, such as CMC (Chemistry, Manufacturing, and Controls) sections.

⦁ Guideline Adherence:
Compliance with global regulatory standards like FDA, EMA, or WHO.

7. Specialized Formulation Areas

⦁ Novel Drug Delivery Systems (NDDS):
Liposomes, nanoparticles, or targeted delivery.

⦁ Controlled/Modified Release Formulations:
Sustained-release or delayed-release systems.

⦁ Pediatric/Geriatric Formulations:
Customized dosages and formats for specific populations.

These steps collectively ensure the drug product is safe, effective, and suitable for clinical and commercial use.

Formulation development has been categorized based on the dosage forms being developed. Each type involves unique considerations tailored to the route of administration and product characteristics.

1. Solid Dosage Forms

⦁ Tablets:
Immediate-release, controlled-release, chewable, effervescent, or dispersible tablets.

⦁ Capsules:
Hard gelatin or soft gelatin capsules filled with powder, pellets, or liquid.

⦁ Powders/Granules:
For reconstitution, direct administration, or blending in food.

2. Oral Liquid Dosage Forms

⦁ Solutions:
Clear liquid formulations for immediate drug availability.

⦁ Suspensions:
For poorly soluble drugs, requiring uniform particle dispersion.

⦁ Syrups/Elixirs:
Sweetened liquids for pediatric or geriatric patients.

3. Injectable (Parenteral) Dosage Forms

⦁ Solutions:
For immediate systemic effects.

⦁ Suspensions:
For long-acting release.

⦁ Emulsions:
For delivering lipophilic drugs.

⦁ Lyophilized Products (Freeze-Dried):
For enhanced stability and reconstitution.

4. Semi-Solid Dosage Forms

⦁ Creams, Gels, and Ointments:
For topical application.

⦁ Suppositories:
For rectal or vaginal administration.

5. Inhalation Products

⦁ Metered Dose Inhalers (MDIs):
Pressurized systems for aerosol delivery.

⦁ Dry Powder Inhalers (DPIs):
Powder formulations for respiratory administration.

⦁ Nebulizers:
Liquid solutions or suspensions converted into aerosols.

The formulation development focuses on creating eco-friendly and biodegradable products, ensuring they have minimal impact on the environment throughout their lifecycle.