Benda’s Jiangling Plant Gets Production Approval
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - Benda's Jiangling plant has received approval from China's State FDA for the production of active pharmaceutical ingredients, the company announced Jan. 22
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SHANGHAI - Benda's Jiangling plant has received approval from China's State FDA for the production of active pharmaceutical ingredients, the company announced Jan. 22. The product production approval is the last step in the good manufacturing practice certification process, the company said. The Hubei-based plant is managed by the Benda Pharmaceutical subsidiary Jiangling Benda Pharmaceutical, which focuses on the production of bulk chemicals and APIs. "The production approval is for the product category - APIs that are registered with SFDA," Benda Spokeswoman Vivien Yeh told PharmAsia News. "It is not for a specific kind of product or medicine." The approval impacts Jiangling's API product lines, but not the production of bulk chemicals, according to Yeh. "APIs are required by SFDA to comply with GMP, but there are no GMP requirements for bulk chemicals," Yeh said. Yeh added that the Jiangling plant will produce three APIs in the plant: ribavirin, asarin and levofloxacin mesylate, a synthetic broad spectrum antibacterial agent for oral and intravenous administration. The Jiangling plant closed in July 2004 to upgrade its infrastructure to secure GMP certification. The GMP process was unexpectedly delayed due to the much-publicized restructuring of SFDA, the company said. In August 2007, Jiangling reopened and started to produce bulk chemicals. Benda has completed infrastructure changes, including upgrading plant facilities, registering the products with SFDA and attaining production approval, and is awaiting completion of on-site inspections by SFDA officials, according to Yeh. "It should happen any day in the very near future," Yeh said. The plant will begin API production as soon as it is granted final GMP certification, the company said. Jiangling could potentially produce 315 tons of API and 620 tons of bulk chemicals annually, generating $11 million in revenue, the company said. Tracy Fang, a Shanghai-based analyst at Frost & Sullivan, told PharmAsia News that SFDA has been restructured greatly in the past two years. "Before the restructuring, thousands of drug manufacturers got the GMP certification, even bought it easily," Fang said. "But in the past two years, the GMP approval process has been very strict." A new GMP inspectional guideline was put into practice on Jan.1, Fang noted. The guideline "has further increased the requirement for manufacturers," Fang said. "The software standard has been raised and the importance of quality control has also been emphasized" (Also see "China's SFDA Sets New GMP Inspectional Guidelines" - Scrip, 19 Nov, 2007.). Under this new policy, industry resources could be further consolidated as some inefficient manufacturers will be unable to meet the new, stricter requirements and will shut down, Fang predicted. Benda's products are not currently sold in the U.S or European Union. "Benda, at this stage, only sells its products domestically. Benda will, and is working up toward its ultimate goal of international sales," Yeh said. "Being able to sell internationally or not is irrelevant with GMP certification here." "We will expect much more complicated procedures from different countries for Benda to comply with in the future to realize international sales," Yeh added. Benda also released an update on the order status for oncologic Gendicine , manufactured by Shenzhen-based subsidiary SiBiono. By the end of December, SiBiono realized $3.3 million in revenue from the $3.8 million of Gendicine orders generated at a national biotechnology conference in September 2007, eclipsing the mark it had previously set for the month (Also see "Lucrative Conference: Benda Recognizes $1.3 Million For Gendicine Order" - Scrip, 13 Dec, 2007.). "Gendicine passed clinical trials in India in November 2007 and is waiting for sales approval from the Indian FDA," Yeh said. "It is an ongoing process, which is expected to be completed in 2008." Benda hopes a Gendicine approval in India will have a positive impact on the application process in other countries, helping to pave the way for the product's entry into other foreign markets (Also see "Benda Anticipates 2008 Approval In India For Gene Therapy Product" - Scrip, 26 Nov, 2007.). Gendicine is the world's first commercialized gene therapy medicine for the treatment of head and neck cancers. - Dai Jialing ([email protected]) |