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    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi's Laboratories — an Indian active pharmaceutical ingredient (API) manufacturer and until recently the darling of the Indian bourses — received another setback this week.  The US Food and Drug Administration (FDA) placed its Unit II, located in Visakhapatnam, on its import alert list for “refusing FDA foreign establishment inspection” as also for “not meeting drug GMPs” (good manufacturing practices). According to the FDA website “the refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.” The firm is considered to have refused the FDA inspection. This news comes as a surprise, as it adds an additional dimension to the problems that the FDA encountered at Divi’s facilities.  PharmaCompass had previously shared news that Health Canada had placed the company on its inspection tracker after data integrity and general GMP observations were reported by its “regulatory partner(s)”.  According to media reports, the firm was inspected by the US FDA from November 29 to December 6, 2016, and the regulators had issued an 18-page long Form 483 with five observations. Second Divi’s group firm to refuse inspection   The news comes a few months after its affiliate – Divi’s Pharmaceutical Private Ltd was placed on FDA’s Import Alert List for refusing an inspection by the US FDA. The two facilities of Divi’s Pharmaceutical  that were placed on the FDA’s Red List were Divi Towers in Hyderabad, and a facility in Medak district, Telangana. Divi Towers is also the corporate headquarters of Divi’s Laboratories. Divi’s Laboratories’ Unit-II is a major producer of APIs and a key supplier to leading companies around the world. The FDA has excluded some intermediates and the following APIs from the import alerts – Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium , Raltegravir potassium and Atovaquone.  The exemptions did not help as far as the stock market was concerned. Divi’s stock price, which has already been under significant pressure after news of the inspection initially broke out in December, tanked another 20 percent on Tuesday. Our view   While the details are yet to emerge on the exact nature of problems which the US FDA inspectors uncovered and encountered at Divi’s Laboratories Unit II, it is clear that Divi’s has a long road ahead insofar as regulatory compliance is concerned.

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    https://www.pharmacompass.com/radio-compass-blog/divi-s-labs-on-fda-s-import-alert-list-but-did-it-refuse-an-inspection

    #Phispers by PHARMACOMPASS
    23 Mar 2017
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    Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States

    Dr. Reddy’s largest API facility maybe the next to get banned from exporting to the United States

    Dr. Reddy’s largest active pharmaceutical ingredient (API) plant in Srikakulam (Andhra Pradesh, India) was inspected by the USFDA in November, 2014. The Srikakulam facility received nine inspectional observations and the company said, immediately after the inspection: “we will respond to the agency within stipulated timelines with our remedial plans and start implementing the necessary measures immediately”. The initial response indicated that the deficiencies at the Srikakulam plant were manageable. However, and in view of the recent USFDA import ban on the Ipca Laboratories’ facility in Pithampur (Madhya Pradesh - India), is it possible that Dr. Reddy’s Srikakulam facility could also be banned?  ENTER HEALTH CANADA The basis on which the USFDA could potentially ban the Dr. Reddy’s Srikakulam plant, is that the facilities of both Ipca and Dr. Reddy’s were put under an import ban on December 23, 2014 by Health Canada citing concerns of data integrity at both sites. Health Canada states in their release: “This action comes in light of recent information from a trusted regulatory partner that raises concerns about the reliability of the laboratory data generated at these sites.”  Health Canada also lists the products impacted by the quarantine to be Domperidone, Valsartan, Capecitabine, Naratriptan and Desloratadine. The Naratriptan ban is noteworthy as Teva & Sandoz, both who produce their product using Dr. Reddy’s API, are the only approved products on the Canadian market, and Naratriptan is now on the Canadian drug shortage list.  Following the Canadian alert, the Ministry of Health in the United Arab Emirates, also decided to stop the importation and distribution of the products from Ipca’s Pithampur and Dr. Reddy’s Srikakulam sites. US MARKET The magnitude of the inspection was revealed by Dr. Reddy’s Co-Chairman & CEO, GV Prasad, when interviewed by the business channel CNBC in January. He mentioned that the launch of both the generic Novartis’ Diovan (Valsartan - used to treat high blood pressure and congestive heart failure) and AstraZeneca’s Nexium (Esomperazole Magnesium – used to treat symptoms of conditions involving excessive stomach acid), would not occur unless the USFDA inspection report is closed. Almost immediately after the inspection, Dr. Reddy’s announced the possible shift of the manufacturing of some key products from Srikakulam; including Esomperazole Magnesium. Nexium sales in 2014 were $3.6 billion and currently only Teva’s subsidiary, Ivax, has an approved generic on the U.S. market ; so Esomperazole Magnesium is definitely a strategic growth driver for Dr. Reddy.  In view of all the available information, the challenges confronting Dr. Reddy’s Srikakulam facility are immense. However, Dr. Reddy’s has overcome an import alert for their Mexican facility in the past, and hopefully, will be able to overcome the problems at Srikakulam.  Also, a setback to Dr. Reddy’s, will further tarnish the image of the Indian pharmaceutical industry, which has had more than a dozen facilities receiving USFDA warning letters, because of data integrity concerns in the past two years.Click here to read the 9 observations at Dr. Reddy's Srikakulam API plant (source: Nomura).    

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    https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-largest-api-facility-maybe-the-next-to-get-banned-from-exporting-to-the-united-states

    #Phispers by PHARMACOMPASS
    30 Mar 2015
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    USFDA observations at Dr. Reddy’s Srikakulam API plant

    USFDA observations at Dr. Reddy’s Srikakulam API plant

    Update 2015 May 28:  Click here to see the orignal form 483 issued to Dr Reddy'sObservation 1Lab records don't include complete data derived from all tests. The inspectors indicate five instances where all the test failures were not documented and reported as per standard operating procedure (SOP). The reported results don’t contain the earlier sample analysis. Observation 2 The inspection highlights unauthorised access to computer system. An instance was noted where data was deleted by an unauthorised person. Observation 3 The Batch production and control records didn’t have the entries filled after each and every step as required by SOP. The data were filled simultaneously. Observation 4 Procedures regarding the issuance, revision, superseding and withdrawal of documents not followed. Observation 5 Water used in the manufacture of APIs is not established to be suitable for use. The microbiological test methods were not verified and validated. Observation 6 Record of training of operators not maintained properly. Observation 7 Failure to justify and follow up on deviations or batch failures: The inspectors made two observations where a batch has failed on certain parameters. Either the investigations are incomplete or the conclusion was not satisfactory. Observation 8 Process validations: The inspectors raised questions on the process validation approach that would ensure that the process can be performed effectively and reproduce the desired results. The inspectors highlight a case of significant numbers of reprocessing carried out by the company, raising questions on the process. Observation 9 Adequate and clean washing and toilet facilities are not provided for personnel. The inspectors highlight that toilet facilities are located at a long distance. Source: Nomura  

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    https://www.pharmacompass.com/radio-compass-blog/usfda-observations-at-dr-reddy-s-srikakulam-api-plant

    #Phispers by PHARMACOMPASS
    30 Mar 2015
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