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FACILITIES

API

As one of the pioneering API manufacturing facilities in the world, Allice drugs LLP mainly focuses on the research of generics for therapeutic categories like Pain management, Drugs acting on Central Nervous Systems, Anti allergic drugs and lifestyle-related diseases such as Cardiovascular drugs, Anti Diabetics and Anti-ulcer drugs. Our main aim as an API development pharmaceutical company is to meet the specific needs of every customer. During our research and development, we maintain close contact with our users and regularly incorporate their feedback into the process. This makes our products more customer and user-friendly. IOL Chemicals and Pharmaceuticals Limited is amongst the leading API partners for pharmaceutical companies across the world. We have a prominent presence in domestic and international markets. We have state-of-the-art R&D centres situated in Jammu, India. As a leading API Pharma plant, when it comes to research and development, we always believe in customer oriented solutions and focus on 100% backward integration. As API development pharmaceutical company, we use indigenously available raw materials, concentrate on in-house manufacturing of Key Starting Materials and intermediates and continuously monitor quality and cost. Our API R&D function is backed by a team of 50 qualified and dedicated researchers with highly specialized qualification in Chemistry/Technology like PDF, Ph.D. in Chemistry and Pharmaceutical Technology, Master in Science, and Master in Pharmacy. At Allice drugs LLP, R&D division works round the clock and operates 24*7. It is well equipped with full-fledged process development laboratory with advanced analytical laboratory having advanced instruments such as LC-MS, Multi gradient High Performance Liquid Chromatography with PDA, RI and UV detectors, Gas Chromatography with Head space analyzers, Malvern 3000 and 2000 particle size analyzer, Infrared Spectroscopy, Ultraviolet spectroscopy and Digital Polarimetry. The PP is equipped with 0.3 KL to 1.0 KL SS and Glass lined Reactors, Powder Processing Area with HVAC system and Micronized with other supporting equipment and utility supply including oil heating system. As an active pharmaceutical ingredients research company, we have in-depth experts in engineering, science and Pharma combined with extensive software skills. All these resources culminate to form our holistic research and development team and help us to make the future together.
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FACLITIES

The formulation development process involves several stages, including pre-formulation studies, formulation design and evaluation, manufacturing scale-up and process development, analytical development and characterization, and stability and shelf-life determinations.

Drug formulation is one of the most critical aspects of the pharmaceutical development process. If a drug cannot be delivered in a stable form that is acceptable to the patient, it is unlikely to find a sizable market, and it may not even go beyond Phase I clinical trials. At Allice drugs LLP, we provide drug formulation development for both clinical trials and final dosages. Below, we share our insight into the drug formulation process.

Drug reformulations studies are the first step in formulation development. During this phase, we identify the chemical, physical, and mechanical properties of a drug to determine the inactive ingredients, or excipients that should be paired with it. The goal is to create a formulation that is stable under a variety of conditions, from extreme cold to extreme heat. Adding excipients can change a drug’s qualities and ensure an end-product that doesn’t degrade during shipment or storage.

CONTRACT RESEARCH & MANUFACTURING

FORMULATION:

Allice drugs are providing formulation development and contract manufacturing services.

The state-of-the-art formulation facility having research team comprising of senior scientists. Who have experience in developing safe, effective and efficacious complex drug products meeting global regulatory requirements.

The Formulation Development facility comprises of two divisions:

· Formulation Development Laboratory

· Analytical Development Laboratory

Some of the major activities undertaken are:

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Pre-formulation Developmen

Objective is to generate information useful in developing bio available dosage forms. The study includes information on parameters like physiochemical property of the drug (like drug solubility, partition coefficient, dissolution rate, stability, solid state analysis like polymorphs, particle size), establishment of kinetic rate profile, excipients compatibility studies etc.

Formulation Development

R&D houses capabilities and resources to formulate a wide range of sterile and non-sterile dosage forms including Solid Orals (Tablets & Capsules), Oral Liquids, Oral Suspensions, Lyophilized formulations and Sterile Injectables
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Analytical Development

Formulation Development Laboratory is supported by Analytical Development Laboratory, which carries out the following activities as per GLP requirements:

· Pre-formulation studies like solubility, forced degradation, excipients compatibility. 

· Analytical method development, validation and transfer.

· Bio-relevant dissolution for formulation selection.

· Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients.

The laboratory is equipped with sophisticated equipment like HPLC, GC, GC-HS, Dissolution apparatus, FTIR etc.