Unimark Remedies Ltd, WARNING LETTER

Warning Letter
 
VIA UPS                                                                                           
WL: 320-15-17
September 28, 2015
During our March 18-21, 2014 inspection of your pharmaceutical manufacturing facility, Unimark Remedies Ltd., located at 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs).
These deviations cause your APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
Mehul Parekh
Entrepreneurs: Healthy outlook
Though careers in this field are cropping up, it’s tough for entrepreneurs to find a foothold. “When I started my business, I took whatever work came my way. Beggars can’t be choosers and neither can start-ups,” says Mehul Parekh, MD and founder, Unimark Remedies. Parekh always knew he wanted to be an entrepreneur but couldn’t make up his mind about the field. He studied to become a chartered accountant and worked for six months to learn the ropes of running a business.In 1982, Parekh set up Rainbow Fine Chemicals, a pharmaceutical marketing company with Rs 3 lakh as seed money. However, Parekh knew that the opportunity and money were in making medicines. So, after his brother got a master’s degree in organic chemistry, Parekh decided to venture into the field confident in the knowledge that he could bank on his brother’s expertise. In 1995, he set up a manufacturing unit and renamed his company Unimark Remedies. “The biggest challenge is always funding. I bought the premises simply because the owner was the only one willing to sell it on credit,” says Parekh. In 1997, he purchased another plant, this time promising the owner that if he put in the capital, he would get to share the profits. “I avoid putting in huge amounts because it blocks the money that can be invested in more important areas,” he adds.

Besides funding, another roadblock faced by entrepreneurs is government regulations. Concurs Das: “Some subjects, such as highway emergency, are nobody’s baby. The police dumps it on the Transport Department, which says it’s a Health Ministry issue, which, in turn, states accidents to be a police matter.” If such issues were to deter people like Das, the healthcare sector would be in a comatose state. The fact that it has begun to emerge from it speaks volumes about the healthy outlook of such entrepreneurs.

Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India,

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Author: 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......http://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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