IHS Chemical Week


Pharma/fine chemicals roundup—31 December 2013

4:59 AM MST | December 31, 2013 | By DEEPTI RAMESH

Chinese firm to acquire US API producer Scientific Protein Laboratories for $337.5 million

Shenzhen Hepalink Pharmaceutical (Shenzhen, China) says that it has entered into a stock purchase agreement to acquire Scientific Protein Laboratories (SPL; Waunakee, WI), a global, independent manufacturer and supplier of active pharmaceutical ingredients (APIs), for $337.5 million in cash plus certain contingent payments. The transaction is expected to close during the first half of 2014.
Hepalink is one of the largest suppliers of heparin sodium API and crude heparin in the world, distributing its products to the global market. Heparin is a blood-thinning drug. Hepalink was established in 1998 and was listed on the Shenzhen Stock Exchange in 2010. SPL specializes in biopharmaceutical manufacturing and is one of the largest commercial suppliers of heparin sodium, pancreatin, and pancrelipase. SPL serves the pharmaceutical, veterinary, and food industries globally, and has a manufacturing facility at Waunakee as well as a facility at Sioux City, IA. When the transaction is completed, SPL’s management will remain in place, as will its 204 employees in the United States.

Global API market to reach $159 billion by 2016

The global sales of active pharmaceutical ingredients (API), which reached $101 billion in 2010, is expected to grow to about $159 billion by 2016, says a recent report by market research and consulting company MarketsandMarkets. The high-potency active pharmaceutical ingredient (HPAPI) market is driving the API market growth globally at a faster rate, the report says. As these compounds are extremely effective in the treatment of cancers, respiratory disorders, and hormonal imbalances, the HPAPIs market is mostly driven by the growth in the oncology therapeutics market worldwide. The global HPAPI market was valued at $8.9 billion in 2011 and is growing at a substantial CAGR, the report says.

FDA invites comments on GDUFA information technology plan

The US Food and Drug Administration (FDA) has announced the availability for public comment, the draft information technology (IT) plan entitled ‘GDUFA Information Technology Plan’. This plan is intended to provide FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) performance goals and procedures for fiscal years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals, FDA says. Electronic comments on the draft plan can be submitted to http://www.regulations.gov
GDUFA is designed to speed the delivery of safe and effective generic drugs to the public. GDUFA increases FDA’s authorities and responsibilities to address issues such as drug shortages, drug supply chain, safety, security, and drug innovation. GDUFA became effective on 1 October 2012. GDUFA requires industry to pay user fees to supplement the costs of reviewing generic-drug applications and inspecting facilities. The program also ups the number of inspections of US and overseas manufacturers of generic active pharmaceutical ingredients and finished pharmaceuticals.

Shasun appoints former API business head at Aesica as president/business growth

Shasun (Chennai, India), a manufacturer of pharmaceutical intermediates, active pharmaceutical ingredients (APIs) and formulations, says it has appointed Kevin Cook as president/business growth. Cook is based at Shasun’s manufacturing facility at Dudley, United Kingdom and reports to Shasun managing director, Abhaya Kumar. Cook has over 25 years of experience in the industry, and was most recently managing director/API business unit at Aesica Pharmaceuticals (Newcastle, UK). Prior to that, Cook was president of Shasun Pharma Solutions at Dudley. As president/business growth, Cooks works closely with the Shasun business development teams to promote the company’s manufacturing offering; his key areas of focus is increasing the manufacturing customer portfolio, identifying and creating new business lines and expanding Shasun’s API offerings.

Beyond IHS Chemical Week:

API maker fined $196,000 after workers exposed to hazardous chemicals
from in-PharmaTechnologist.com

Dissolved API maker Archimica Chemicals has received fines of $196,000 after workers exposed to hazardous chemicals were hospitalized at a plant in Wales, UK.

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