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The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China.

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FDA issues Warning Letter for API Facility

http://www.gmp-compliance.org/enews_4367_FDA%20issues%20Warning%20Letter%20for%20API%20Facility_8509,S-WKS_n.html
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.


FDA issues Warning Letter for API Facility
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility.

For quite some time India was in the center of attention and very little was heard about GMP problems in China (see also RAPS article). This is a bit surprising because a number of non-compliant facilities have been detected in the past. Also the facilities which caused the Heparin Scandal were located in China. The last enforcement action from FDA which became public referred to Import Alerts for the manufacturer Zhejiang Jiuzhou Pharmaceutical and for Zhejiang Zonebanne in China.

The new Warning Letter for Tianjin Zhongan Pharmaceutical lists a number of different non compliance findings. These findings refer to equipment cleaning (risk of cross contamination), not adequate Change Control procedures and failure to adequately review and investigate product deviations. However, in difference to the Warning Letters sent to Indian manufacturers recently data integrity issues have not been detected.

Interestingly the API manufacturer Tianjin Zhongan Pharmaceutical is not listed in EudraGMDP the inspection database in the EU. No entry for GMP Certificates or GMP Non-Compliance Report are available.

Source: FDA Warning Letter to Tianjin Zhongan Pharmaceutical

Tianjin Zhong’an Pharmaceutical Company Ltd. locates in the southwest of Tianjin. Set up in 1988, the company underwent operation mechanism reform in 2002 and acquired the present name.

The company covers an area of 82,000 square meters, with a construction area of 31,600 square meters and an afforested area of 13,300 square meters. It has over 600 staff members, more than 50 of whom have been conferred intermediate or advanced titles of technical post. The company produces 10 major chemical bulk pharmaceuticals, including Caffeine, Theophylline, Aminophylline, Metronidazole, Metronidazole Benzoate, Nifedipine, Secnidazole and Xanthinol Nicotinate. Its annual production capacity amounts to 4000 ton, with a sales volume of approximately RMB 250 million. Two leading products in the company are Caffeine and Metronidazole.

Zhong’an Pharmaceutical enjoys a self-management power over import and export., 90% of its products are aimed at international market, with 60% of which sold directly to world-renowned pharmaceutical and beverage enterprises. It has established a sales network which covers more than 30 countries and regions, including some European and American countries, Hong Kong, Taiwan and Macao, countries in Southeast and Midwest Asia, and Russia.

Zhong’an Pharmaceutical has set up a full set of quality assurance system, and owns a central laboratory with advanced analyse instruments that has got the title of Export Enterprise Lab and approved by Tianjin entry-exit inspection and quarantine bureau. All workshops of the company are dedicated to avoid the issue of cross pollution. Every stage of production strict complies with the cGMP, which led to the products has been enjoying a high reputation both domestic and overseas market.

Since 2000, the company has obtained GMP and ISO9001certificates, and conferred the title of Tianjin High-new Tech Enterprise and Municipal-level Key Technical Center. Both of leading products Metronidazole and Caffeine have got COS issued by EDQM and DMF register number from US FDA. Also Caffeine has got “Foreign Manufacturer Validation Certificate” from Japan Health Ministry and KOF-K and Halal certificates.

 


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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