IHS Chemical Week


Pharma/fine chemicals roundup—25 October 2016

12:00 AM MDT | October 25, 2016 | By DEEPTI RAMESH

Ashland opens pharmaceutical excipient production facility in China

Ashland says it has opened a new pharmaceutical excipient production facility at Nanjing, China. Demand for polymer excipients, the substances formulated alongside the active ingredients of medications, is rising in China as the country’s pharmaceutical industry moves to modernize oral drug manufacturing and comply with new quality standards set forth in the 2015 edition of the Chinese Pharmacopoeia, Ashland says. Ashland now manufactures its major brands of excipients in Nanjing to better serve China’s pharmaceutical industry.
Among the cellulose-based excipients, Ashland will make available to China’s markets include those sold under the Klucel HPC, Benecel HPMC, Blanose CMC and Aqualon EMC trade names. The company also will make available a series of polyvinylpyrrolidone (PVP)--based polymer excipients, including Plasdone PVP and Polyplasdone polyvinylpolypyrrolidone (PVPP) polymers. All of these products are sold with a registered pharmaceutical excipient certificate, as required by the China Food & Drug Administration, Ashland says. Alongside Ashland’s first ever pharmaceutical excipient production facility in China is a quality control laboratory that contains equipment to measure and analyze products throughout the production process.
Ashland says it also recently expanded its technical center in Shanghai, China to support customers in China with services that may be required to ensure manufacture of tablets containing an Ashland excipient, and customers will also gain access to capabilities for bioavailability and solubilisation enhancement and the latest coating and tablet formulation technologies.

Thirumalai Chemicals to expand fine chemicals capacity in India and Malaysia

Thirumalai Chemicals (Mumbai, India) says that the company’s board of directors, in a meeting held on 19 October, approved capacity expansion projects in India and Malaysia. The projects include expanding fine chemicals capacity at the Thirumalai manufacturing site at Ranipet, India, by upgrading its fine chemicals production unit. That project, nearing completion, will add about 40% capacity in the fourth quarter, the company says. The company also plans to expand fine chemicals capacity at Ranipet by a further 40% by 2018. Thirumalai's wholly owned subsidiary, Optimistic Organic Sdn Bhd (OOSB; Petaling Jaya, Malaysia), which operates a production site in the Teluk Kalong Industrial Estate in Kemaman, Malaysia is planning to build a plant for producing fine chemicals, the company says.

Dottikon collaborates with Bachem on novel amino acids

Fine chemicals company Dottikon Exclusive Synthesis (Dottikon ES; Dottikon, Switzerland) says that it is extending its collaboration with Bachem, in the area of novel amino acids. Bachem is a technology-based company focused on peptide chemistry. Bachem specializes in the development of manufacturing processes and the production of peptide-based active pharmaceutical ingredients (APIs). Dottikon ES manufactures performance chemicals, intermediates and exclusive APIs for the chemical and pharmaceutical industries. The collaboration between the two Swiss companies covers the development, manufacturing, and distribution of enantiomerically pure amino acids, for example for peptide synthesis. Bachem is the global leader in exclusive custom synthesis of peptides for preclinical and clinical pharmaceutical research, Dottikon ES says.

Beyond IHS Chemical Week:

Large-scale imports of APIs from China, a worry for Indian pharma industry
from Business Standard

The over-dependence of the Indian pharmaceutical industry on imported pharmaceutical raw materials from China to meet the growing requirements of drug formulations is a cause for concern for the industry as well as policymakers. India may have emerged as a key supplier of generic and affordable medicine to the world market, but its overwhelming dependence on China for active pharmaceutical ingredients (APIs) and intermediates, which is over 65% of the requirement, is a worry, according to an Assocham-RNCOS joint paper.

FDA issue warning letter to Japanese API manufacturer
from Pharmaceutical Technology

FDA officials warned Japanese API manufacturer Nippon Fine Chemical Co. for refusing to allow FDA officials to inspect the company’s facility, located at Takasago City, Hyogo. In a warning letter dated 26 September, 2016, officials said “your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited inspection and refused inspection.”
According to the letter, during the inspection a control manager told employees to stand “shoulder-to-shoulder” barring FDA investigators from entering sections of the laboratory and equipment. The warning letter also states that FDA reviewed complaints received about drugs from customers, including complaints that they contained glass, hair, cardboard, metal, product discoloration, and a black spider. FDA said, “your firm limited the inspection by refusing to provide FDA copies of these records.” FDA said a quality assurance manager at the facility also impeded the FDA inspector from taking pictures of machinery used to manufacture drugs for US distribution.
The firm was placed on Import Alert on 8 August, 2016. Until FDA can inspect the facility, the agency said it can recommend withholding approval of any new applications or supplements listing the company as a drug manufacturer. Additionally, shipments from the facility are subject to refusal of admission.

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