GENERICS

In 2011 market research (GBI Research) showed that the South African Private market was valued at approximately US$ 3.8 billion. Through Government policies, pressure from the Health Insurance companies and expiration of many leading brands patents, generics make up approximately 62% of the market. This number is growing at approximately 16% per annum.

Trinity Pharma's strategic focus is to supply generics to the largest pharmaceutical retailers in South Africa, and ultimately Africa. The management team has a long and close working relationship with the leading major South African retail pharmacy chains and healthcare groups.

Currently, Trinity Pharma successfully markets registered pharmaceutical products in South Africa. Their pipeline consists of over 50 molecules which are in the process of being registered with the MCC. These products extend over all major therapeutic classes.

IN LICENSE OPPORTUNITIES

Since 2011, Trinity Pharma has concluded an impressive number of in-licensing agreements. With their focused and lucrative marketing strategy, Trinity Pharma has secured agreements with a number of leading international generic manufacturers in Europe, India and Canada. Trinity Pharma is continuously looking for In-license opportunities from manufacturers. In return for CTD dossiers that meet the requirements of the MCC, Trinity Pharma signs an exclusive supply agreement for the product with the manufacturer. Through its innovative and unique model, Trinity Pharma is able to offer manufacturers a substantial share of the South African market, with minimum guaranteed annual orders.

The team are actively exploring opportunities to increase their pipeline across all therapeutic classes.

Please click here to view their registered product portfolio.

SPECIALIST MEDICINES NOT YET REGISTERED WITH MCC (Section 21)

Trinity Pharma assists with the importation of specialised medicines which are not yet registered in South Africa with MCC. The medicines are typically prescribed by doctors for specific patients, who are critically ill. A Section 21 permit is required from the MCC to import these unregistered medicines.

Trinity Pharma assists the physician and the patients with the application to the MCC and will import the products from the international supplier once the permit is issued



COMPLIMENTARY OTC PRODUCTS

Complimentary OTC products are medicinal products that do not require full pharmaceutical registration. These products are attractive as the approval process from the MCC is approximately 4 to 6 months. Depending on the therapeutic class and target market, they partner with selected companies with the necessary marketing and sales capabilities and expertise.

 Active Ingredient

 Brand

 Ester C  Ester C tablet
 Ester C  Ester C tablet
 Bacopa Monnieri extract  Bacomind
 Ocimum Sanctum  Ocibest
 Glycyrrhiza glabra extract  GutGuard

TENDERS AND THE PUBLIC SECTOR

The South African public sector serves over 40 million patients annually. It was valued at US$ 340 million in 2011. As with most tender markets, the volumes are substantially higher than the Private sector, but the prices are more competitive and per-capita expenditure is much lower.

To meet government requirements, Trinity Pharma participates in Government tender by partnering with strategic Black-Empowered companies. This participating takes place with both their own branded products as well as on behalf of their principal clients' brands.



PRODUCTS

The following is a list of the products in their portfolio. Currently, there are over 50 dossiers pending registration with the MCC.

  Active Ingredient

 Brand

 Package Insert

 Polyhexadine  CytrinClean  pdfPackage Insert
 Mepyramine maleate, Codeine phosphate  Codomill  pdfPackage Insert
 Promethazine hydrochloride  Brunazine  pdfPackage Insert
 Aminophylline, Diphenhydramine HCI, Ammonium chloride, Sodium citrate  Diphenamill pdfPackage Insert
 Promethazine hydrochloride, Ephedrine hydrochloride, Codeine phosphate  Brunacod  pdfPackage Insert
 Risperidone  Rispevon  pdfPackage Insert
 Finasteride  Intas Finasteride  pdfPackage Insert
 Amlodipine  Pendine  pdfPackage Insert
 Losartan  Renicard  pdfPackage Insert

Active ingredient = Polyhexadine (CytrinClean)
* No Ephedrine or Codeine, or products containing these ingredients are kept on Trinity Pharma’s premises.

Detailed guidelines on the requirements to register a pharmaceutical product with the South Africa Drug Regulatory authority the Medicines Control Council (MCC), can be found on their website (http://www.mccza.com), at the following link for regulatory guidelines:. Regulatory guidelines