Pharmacare Premium
Setting the Base for Generics Development and Day-one Launch

Situated in the middle of the Mediterranean Sea, Malta is a chain of islands known for its breathtaking landscapes. It receives significant footfall from tourists across the globe. However, not many know that Malta is a growing startup hub, especially for life sciences companies. Backed by the government’s multi-million-dollar investments in infrastructure and lab facilities for R&D units, it has become a haven for drug developers, biotech companies, contract manufacturers, and medical device makers. On top of that, Malta’s Bolar exemption provision provides a favorable legal environment for generic pharmaceutical companies, enabling them to develop their product in the period until the patent expires.

Realizing these opportunities early on, Pharmacare Premium, a pharmaceutical manufacturing company dedicated to developing generic oncology products, established its state-of-the-art facility in Malta in 2015. With an array of services, from contract manufacturing and contract development to stability studies, contract packaging, and day-one launch for high-potency oral dosage forms, Pharmacare Premium has today become a trusted name in the industry for the development of generics and ‘day 1’ launch into the EU and beyond.

Pharmacare Premium’s core competency lies in handling highly potent molecules for oncology, immunosuppressants and other therapeutic categories. Its well-equipped and licensed labs are also capable of conducting stability studies for potent molecules with OEB 4 and OEB 5 in all climatic zones.

Specialized Facilities for Handling Hazardous Molecules

Pharmacare Premium has designed special controlled areas and equipment to handle highly toxic materials with all the necessary isolators and health and safety precautions. For example, the company has a male-only policy in the production of molecules that are extremely toxic to female reproductive health.

In addition to responsibly handling toxic materials, Pharmacare Premium has capabilities to meet large and small quantity requirements to support day-one launch for every market. The day-one launches are not always about large quantities. In smaller markets such as Hungary, Romania, the Czech Republic, Slovenia, and so forth, launches will require a smaller quantity of products. Pharmacare Premium has designed its production, operations, packaging, and other capabilities so that it can fill orders in the thousands or as few as 100 boxes.

“Our main advantage for day-one launches of potent molecules is that we can deliver small orders of niche products or products with multiple strengths,” says Hani Sarraf, Director of Business Development at Pharmacare Premium.

Catering to Diverse Requirements Under One Roof

Pharmacare Premium has designed its GMP production lines with maximum adaptability.

As a result, commercial tablets and capsules can be produced in batch sizes ranging from 50 to 150 kilograms, as well as in small-scale batches of 0.5 to 5 kilograms. The flexibility of small batch sizes for high-value, low-volume products enables the company to easily address the increasing demand for generic products in the oncology market.

Our main advantage for day-one launches of potent molecules is that we can deliver small orders of niche products or products with multiple strengths, or those requiring dose titration

As the oncology market gravitates toward generics, the next five to 10 years will witness huge demand for small volumes and small quantities of high-value potent products for the day-one launch. Pharmacare Premium’s EU-GMP-approved modern facility, backed by a team of industry professionals, is ready to address this demand.

Pharmacare Premium’s ability to deliver full service as a contract developer, as well as a commercial supplier, gives it an upper hand over the competition. By performing everything in-house—from full development and validation of analytical methods to formulation design and development to dossier compilation—Pharmacare Premium eliminates the need for technology transfer from one organization to another after product development.

“When the formulation development and the commercial launch are done at the same site, the technology transfer, scale up, and process validation batches all become part of one process, enabling clients to bring products quickly in the market,” says Sarraf.

For example, a niche oncology product, out-licensed in Europe, was produced at a contract manufacturer in India. The product was high-value low volume, and the CMO in India, a bulk supplier, couldn’t meet the client’s needs. Their production lines were not designed to cater to order quantities of 100 or 300 boxes. Pharmacare Premium was approached for the packaging of this product in order to fulfil launch requirements in several markets. The company even helped design the sampling protocols for QC testing, retention samples, and ongoing stability, to optimize yields and production runs. As a result, the company met the client’s need for the day-one launch in different countries, including Italy, Germany, and Switzerland, and on different timelines.

In another example, Pharmacare Premium offered contract development services for two particularly potent products. Not many companies accept these drugs for contract development and manufacturing due to their high potency level and special health and safety precaution requirements.

On top of that, it was a low volume requirement with four to five different dosage strengths for each drug. The individual orders for each dosage were extremely low, with batch sizes as small as 750 grams. The ability to handle such potent molecules and the small batch size enabled Pharmacare Premium to complete formulation development, analytical method development, and perform validation batches on an optimized small scale for the customer.

At the Forefront of Trends

The CDMO is just one part of Pharmacare Premium’s business. The company also develops its own generic oncology products for out-licensing. It is also licensed to produce clinical batches and dispatch or release clinical samples for trials. The company can also manage clinical studies on behalf of clients.

Pharmacare Premium also has the flexibility to accommodate specific needs, such as manual packaging. A good example is the generic launch of Apremilast. This product requires ‘starter packs’, as patients need to be titrated on the dose. When initiating their medication, patients need to be started on a small dose and gradually increased to their ideal dosage. This demands starter packs of ten tablets of each dosage, i.e., 10, 20, 30 milligrams, or more. This type of packaging can only be done manually for the generic sector. Pharmacare Premium’s small-scale GMP line can produce these small quantities and help clients minimize waste.

With a continuous focus on growing its capabilities for small quantities instead of just increasing capacity, Pharmacare Premium plans to remain at the forefront of bringing oral oncology products to the market fast. The oral oncology domain has hundreds of specialized products in the pipeline that are (or will be) used as 2nd, 3rd and 4th -line treatments, in combination with other molecules, to treat certain cancers with specific mutations. Most of these molecules are therefore required in small quantities, demanding the CMOs and suppliers to be flexible. Pharmacare Premium is already ahead of this trend.

“With an aim to develop and deliver premium quality products at affordable cost, we are expanding our product line through a pipeline of development projects for an out-licensing drive,” says Sarraf.