Finance USA

Jul 21 2019

AstraZeneca Bulk Pharmaceutical – Pharmaceutical Technology, pharmaceutical validation.#Pharmaceutical #validation



AstraZeneca Bulk Pharmaceutical

Project Type

Estimated Investment

Sponsor Financing

Tablets

Pharmaceutical validation

AstraZeneca’s facility in Guayama, Puerto Rico.

Pharmaceutical validation

PRIDCO hopes that Zeneca’s investments will enhance the island’s reputation as a manufacturing centre.

Pharmaceutical validation

According to the company’s own figures, its soluble, oral version of Zomig was widely welcomed by the sample group. If this is the case, it should boost demand.

In July 1997, AstraZeneca announced plans to invest 15m in its Guayama facility in Puerto Rico. The money was invested in a new bulk pharmaceutical purification plant to supply the global market with zolmitriptan, the active ingredient in a new treatment for migraine called Zomig. The go-ahead for the construction of the plant, which is managed by Zeneca s wholly owned subsidiary, IPR Pharmaceuticals Inc., confirmed the company s decision to increase its investment in the island.

Detailed design plans for the Guayama purification plant were completed by June 1997 and construction began in early 1998. Since then, FDA accreditation has been obtained and the plant now supplies to market. IPR, the established engineering contractors who have design, engineering, procurement, construction management and commissioning / validation experience in Puerto Rico have completed the project. The new facility went operational at the end of 2000. In 2005, the plant was sold off as part of AstraZeneca s restructuring activities.

Guayama bulk purification plant

The Guayama bulk purification plant is located adjacent to an existing purification facility. The plant has several times the capacity for peak demands of Zomig. Consequently, spare capacity is available for other products, as required. Bulk zolmitriptan requirements for all markets are sourced from this plant, while tableting and packaging is undertaken at other sites.

After acquiring zolmitriptan in September 1996 (now sold under the trade name Zomig ), AstraZeneca launched tableting facilities for the drug at IPR s Carolina plant in Puerto Rico. However, as demand for Zomig had been growing (according to company research), it was thought that greater manufacturing capabilities were needed to meet the pharmaceutical industry s requirements. As one of the drug s sole manufacturers, the bulk purification plant at Guayama has made a significant impact.

Astrazeneca investment plan

The Guayama project was part of AstraZeneca s large-scale investment project in Puerto Rico. In addition to the upgrade of the company s facilities at Guayama, AstraZeneca has also upgraded its existing plant at Can vanas. The plant was expanded and inaugurated in March 2004, with a total investment of 400m.

The 134,000ft plant used to produce Crestor, a cholesterol drug, and Casodex, a medication for treating prostate cancer. It had an annual capacity of up to seven billion tablets. The plant also took care of the packaging and distribution activities of AstraZeneca and other products developed by the company in Puerto Rico.

IPR Pharmaceuticals bought the Can vanas facility in 1998 from Chiron Corporation. IPR Pharmaceuticals invested more than $650m in both the Can vanas and its Carolina facility.

Puerto Rico pharmaceutical market

The pharmaceutical industry in Puerto Rico is huge. According to the 1997 manufacturing census of the Department of Labour and Human Resources, some 22,000 people work at 79 different pharmaceutical plants.

The joint decision by IPR and the Puerto Rico Industrial Development Company (PRIDCO) to set the upgrade project at Guayama in motion was testament to the confidence in this sector.

The new plant has enhanced the island s reputation as a world-class manufacturing centre that is home to the most important and prominent international pharmaceutical companies.

Other life-science companies have also invested in projects in Puerto Rico, including Pharmacia Upjohn ($100m), Ocular Sciences / American Hydron ($25m) and Thermometric ($700,000).

IPR Pharmaceuticals Puerto Rico operations

IPR Pharmaceuticals first plant in Puerto Rico was launched in Carolina in 1986. The plant develops several drugs, including Accolate, a medication for asthma, beta-blockers Tenormin and Tenoretic, Zestril, and ACE inhibitors and migraine treatments, Zestoretic and Zomig.

AstraZeneca manufactures several top-selling drugs and a range of high-potential therapies. Its product portfolio includes Casodex, Arimidex, Faslodex and Iressa for treating cancer; Nexium for gastrointestinal diseases; Symbicort for asthma treatment; Atacand for hypertension and Seroquel for the treatment of schizophrenia.



Written by CREDIT