In your response, you explained you would replace. Your investigation into this finding did not sufficiently extend to other drug manufacturing equipment that may also not be properly maintained. Your risk assessment dated January 29, 2019 documented that, In your response you state that you are not using recovered solvents to manufacture, We acknowledge that you have initiated additional process controls and are now testing all manufactured batches of. manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. They referred me to the PDF of the inspection results on 9/1/2017. Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Corepharma, Sandoz, Mallinckrodt and Aurobindo all make a pill which basically tests out to be the 75%/25% dextro-amphetamine/levo-amphetamine salt combo that we know as Adderall IR, by the FDA laws (if you live in the USA). contamination at levels above the acceptable limit. In addition, provide a retrospective review of all distributed batches within expiry to determine if your firm released batches that did not conform to established specifications, official compendium, or appropriate manufacturing standards. The FDA representatives had inspected the facility between February 12 … The FDA finding comes as the Indian drugmaker has significantly increased its … Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to: Please identify your response with FEI 3004611182. United States, Via UPS                                                                                 Warning Letter 320-19-27. Additionally, you are required to notify each person authorized to reference the information in your DMF of the pertinent changes. Conduct a thorough review of all batches of API made at Aurobindo that shows unknown impurities above the reporting thresholds. After you were informed by the European Directorate for the Quality of Medicines (EDQM) that their test results showed your (b)(4) API contained (b)(4), your firm tested more than (b)(4) API batches and determined that (b)(4) batches, approximately (b)(4)%, contained (b)(4) contamination at levels above the acceptable limit. 381(a)(3). I have been prescribed "Adderall" for about 3 years, I am glad I read your post, it is not your imagination!!! We acknowledge that your firm engaged a consultant to assist your firm in meeting CGMP requirements. Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. Failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications. Telangana Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Apotex Corp Issues Voluntary Recall of Drospirenone and Ethinyl Estradiol Tablets; March 1, 2019. You determined the stains were due to the formation of iron oxide (rust) inside the (b)(4). Aurobindo has had similar problems at another sterile manufacturing plant in nearby Bachupally. You are responsible for investigating these deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations in all your facilities. Link included. Deviations cited in this letter are not intended as an all-inclusive list. Aurobindo Pharmaceuticals Limited Issues Valsartan Amlodipine Tablets Recall; February 28, 2019. LACTITOL,MICROCRYSTALLINE CELLULOSE,COLLOIDAL SILICON DIOXIDE,MAGNESIUM STEARATE,AND OTHER INGREDIENTS. impurities in all API manufactured at your firm. Identify corrective actions to ensure adequate quality oversight of operations for contract manufacturers performing functions that could affect drug quality, including any revised qualification and evaluation procedures. Aurobindo Pharma (Reverified 09/25/2020) Company Contact Information: 732-839-9400 Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA) Amphetamine Mixed Salts Tablets C-II 5 mg, 100 (NDC 13107-0068-01) Available Demand increase for the drug: Amphetamine Mixed Salts Tablets C-II 10 mg, 100 (NDC 13107-0070-01) … The citation came just weeks after a key sterile injectables plant in Pashamylaram, Hyderabad, was written up in December for the second time in two years. An official website of the United States government, The U.S. Food and Drug Administration (FDA) inspected your drug. The FDA has opened offices in China, India, Europe, and Latin America, and it now conducts more inspections overseas than within the U.S. It’s also changed how it … Aurobindo LTD (India) Investors; Contact Us; 866.850.2876; Font Size Header Navigation. IMPORTANT UPDATE: The FDA is aware of the issue. 1. Our investigators observed what appeared to be rust on more than (b)(4)% of (b)(4) SRJ014, used to manufacture (b)(4) API. The company said the particles “were intrinsic” to manufacturing when FDA inspectors indicated they most likely were from shedding stoppers. For more information about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, please contact Aurobindo Pharma USA, Inc. at 1-866-850-2876. Changes to methods or controls were not reported to FDA through a supplement to an approved (b)(4). Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive. No. For FDA’s current thinking on control of potentially mutagenic impurities, see FDA’s guidance document M7(R1) Assessment and Control of  DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk for approaches that FDA considers appropriate for evaluating mutagenic impurities, at https://www.fda.gov/media/85885/download. Manufacturing problems persist for Aurobindo, U.S.' second-largest generics producer, FDA finds Aurobindo sterile drug plant continues to have problems. Plot No. Provide a CAPA plan that includes a full review of all equipment contact surfaces to determine if they are reactive/additive to your drugs and whether contact surfaces are suitable for intended use. The problems ran a gamut from poorly trained visual inspectors to the company's indifferent treatment of customer complaints about vials that had black particles in them. 2. Inspections of Aurobindo’s facilities in India resulted in at least half a dozen Form 483’s and a warning letter, according to FDA records. A demand increase has put a generic form of ADHD drug Adderall in shortage. These changes include but are not limited to addition to a specification or changes in the methods or controls to provide increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it purports or is represented to possess. US FDA resumed approving products from Aurobindo Pharma’s unit-3 only around June following its inspection in March. Aurobindo Pharma USA. I have taken Adderall at varying dosages daily for the past 10 years for ADHD and recently picked up a prescription from CVS by the brand name "Aurobindo Pharma". I usually get Teva or Barr generic, sad to say I made the same mistake you did. Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. 351(a)(2)(B). 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, from February 4 to 9, 2019. Repeat Observations at Multiple Sites and Regulatory Meeting. Use a + to require a term in results and - to Submit risk assessments for all API and intermediates manufactured at your facility for the potential presence of mutagenic, For FDA’s current thinking on control of potentially. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. exclude terms. Aurobindo, which is growing its reach in the U.S., has had another sterile drug manufacturing plant criticized by the FDA. Camber Pharmaceuticals Limited Issues Losartan Potassium Recall; February 22, 2019 Aurobindo LTD (India) Investors; Contact Us; 866.850.2876; Primary Navigation. They don't taste anything like normal Adderall IR (Sugary), and i literally feel as if i haven't taken any medication. This Aurobindo is NOT a good generic for Adderall. Aurobindo Pharma Ltd. brand List that includes tablets, capsules, syrups, etc. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, from February 4 to 9, 2019. In your response, you explained you would replace (b)(4) SRJ014 with a (b)(4) that is not susceptible to formation of rust. FDA cited similar CGMP observations at other facilities in your company’s network. The plant’s quality control unit, which should be ensuring products meet the highest standards before shipping to the U.S., doesn’t seem to know what it is doing. Your firm’s. Hyderabad 500038 Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations, Aurobindo Pharma Limited - 577033 - 06/20/2019. We acknowledge that you have initiated additional process controls and are now testing all manufactured batches of (b)(4) API for (b)(4), including (b)(4), as batch release criteria. The site is secure. Following administration of a single dose 10 or 30 mg of Adderall ® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. Aurobindo Pharma USA – Generic Pharmaceuticals. “The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice by Austrian and Dutch authorities in February 2016. Many times, I have learned about company related activities and/or occurences through the news media and not from company management. Brands listed with corresponding Generic name and price details. Your investigation concluded the (b)(4) contamination was due to the use of recovered (b)(4) supplied by (b)(4). See FDA’s guidance document. The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Indian drugmaker Aurobindo Pharma last month and issued a statement drawing attention to three recent warning letters sent to active pharmaceutical ingredient (API) repackers. These facilities are also considered to be in an unacceptable state of compliance with regards to CGMP. Adderall ® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Pharmaceutical Manufacturing. Business Profile. Manufacturing issues have been an ongoing concern of the FDA’s when it comes to Aurobindo. The US Food and Drug Administration (USFDA) has issued Form 483 with 9 observations to Aurobindo Pharma Limited's unit 4 in Hyderabad, citing serious deficiencies in maintaining the manufacturing quality standards. At the time, Aurobindo managing director N. Govindarajan claimed the deal would make his company the second-largest dermatology player in the U.S. generics market and the second-largest generics company by prescriptions. All rights reserved. Any DMF update should also result in notifications to any authorized person for the DMF. 2, Maitrivihar, Ameerpet Silver Spring, MD 20993 The agency this week posted a Form 483 for Aurobindo’s plant in Telangana with nearly a dozen observations but one overriding issue, the agency said. Provide a thorough, independent assessment of your overall system for investigating unknown peaks, deviations, discrepancies, out-of-specification (OOS) results, complaints, and other failures. It's just my opinion, but it's garbage, so much so that I really think the FDA should look into it. Your firm’s executive management remains responsible for fully resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. 3 Speen Street, Suite 300, Framingham, MA 01701. In addition, the inspection revealed that your firm failed to submit supplemental, Your investigation into the root cause of, API was deficient. FDA cited similar CGMP observations at other facilities in your company’s network. India, 10903 New Hampshire Avenue Colors: Adderall ® 5 mg is a white to off-white tablet, which contains no color additives. Your investigation into the root cause of (b)(4) impurities, such as (b)(4), in your (b)(4) and (b)(4) API was deficient. You determined the stains were due to the formation of iron oxide (rust) inside the, . Enclose phrases in quotes. Manufacturer Teva has issued a voluntary recall of two lots of generic Adderall, also known as amphetamine salts or amphetamine salt combo.. After you receive this letter, respond to this office in writing within 15 working days. Provide copies of these notifications to FDA. HYDERABAD: Drug firms Dr Reddy’s Laboratories Limited and Aurobindo Pharma Limited have separately started recalling few quantities of two different drugs from the … remains responsible for fully resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. We reviewed your March 4, 2019, response in detail and acknowledge receipt of your subsequent correspondence. In your response, you acknowledged that your firm did not check the dryness of the inner surface of the (b)(4) after cleaning: therefore, moisture remained in the (b)(4) and caused discoloration. Our investigators observed what appeared to be rust on more than, In your response, you acknowledged that your firm did not check the dryness of the inner surface of the, after cleaning: therefore, moisture remained in the, and caused discoloration. Company . Before sharing sensitive information, make sure you're on a federal government site. I felt nada. Adderall XR with NDC 54092-383 is a a human prescription drug product labeled by Takeda Pharmaceuticals America, Inc.. that is not susceptible to formation of rust. impurities, at https://www.fda.gov/media/85885/download. You reported that recovered (b)(4) is generated from a (b)(4), which is recovered at your contract manufacturer, (b)(4). corrective action and preventive action (, CAPA) plans initiated to address the presence of. Your investigations into poor equipment maintenance are inadequate. Identify any impurities that are present at a level greater than the ICH Q3A(R2) identification thresholds and update your DMFs and. If you have issues with Aurobindo brand Adderall, report it to the FDA. Your response is inadequate, as you did not commit to conduct a full review of all impurities observed in all your APIs above the reporting threshold and ensure that your DMFs and, you must comply with the requirements of 314.70(c)(6)(i) regarding the submission of supplemental, . Aurobindo Pharma, Zydus Cadila and Strides Arcolab did not respond to the queries sent by The Indian Express. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations. You updated the information in your Drug Master File (DMF) only after FDA investigators communicated during the inspection that you should be reporting all observed impurities above the reporting threshold. When Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S. No. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. Pharmacokinetics. The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved (b)(4) may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. You attributed the (b)(4) contamination to (b)(4) inadequate cleaning procedures. Your initial assessment determined that the synthetic mechanism for the manufacture of, API did not have the potential to produce, . But it is one that brings a history of quality issues when it comes to manufacturing, as exemplified in the latest thrashing by the FDA. Failure to extend investigations to other batches that may have been associated with a specific failure or deviation. RELATED: FDA finds Aurobindo sterile drug plant continues to have problems. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Failure to Comply with Submission Requirements for Supplements and Other Changes to an Approved, were not reported to FDA through a supplement to an approved, Your Quality Unit failed to report to FDA these impurities, which were also above your internal reporting threshold limit of no more than, In your response, you explained a “scheduled regulatory update skipped our attention.” In addition, you stated you would undertake an additional CAPA for controls of residual solvents. Dear Mr. N. Govindarajan: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. aurobindo pharma adderall - i am starting to get really scared. In your response you state that you are not using recovered solvents to manufacture (b)(4). No. You may report side effects to FDA at 1-800-FDA-1088. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. These changes include but are not limited to addition to a specification or changes in the methods or controls to provide increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it purports or is represented to possess. However, your response is inadequate because you did not identify corrective actions to ensure other equipment used to manufacture drugs have contact surfaces that are also made of adequate material. The generic name of Adderall XR is dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are 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. It pulled off a smaller deal in January when it agreed (PDF) to pay up to $300 million for seven branded injectable cancer drugs from Irvine, California-based Spectrum Pharmaceuticals, along with what it termed a substantial commercial infrastructure to support them. Register Today! This assessment did not include an evaluation of the potential for key starting materials (KSM), other raw materials, and solvents to result in the presence of, After you were informed by the European Directorate for the Quality of Medicines (EDQM) that their test results showed your. Examples include acquisition of 100+ products from Sandoz, adverse FDA inspection results of Aurobindo plants and fatalities at Aurobindo facilities in India. 351(a)(2)(B). Your investigations into poor equipment maintenance are inadequate. Aurobindo was the mfr of my 1st-ever script for Adderall (and 1st-ever for any ADD med). East Windsor, NJ 08520 … Specify what you have done since our inspection to correct your deviations and to prevent their recurrence. Call your doctor for medical advice about side effects. (Aurobindo), Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules. Your risk assessment dated January 29, 2019 documented that (b)(4) contamination in (b)(4) API originated from recovered (b)(4) and (b)(4) solvents. Still clouded, foggy thinking, heart rate & breathing all same at normal levels, the only difference was I'm $40 in the hole. Your initial assessment determined that the synthetic mechanism for the manufacture of (b)(4) API did not have the potential to produce (b)(4) impurities such as (b)(4) and (b)(4). as required. There is a lack of communication within the company. Those included Sandoz’ U.S. dermatology line. If any raw material, intermediate, or API contact surfaces are found to be deficient, provide a risk assessment, including the impact on potentially affected batches, and actions taken to prevent recurrence. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate. The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aurobindo Pharma Limited (APL), Unit XI at Sy. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. No. Reproduction in whole or part is prohibited. The only reason I knew I took it was I was consciously aware of taking it. Adderall - Clinical Pharmacology Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. As the applicant of (b)(4) and (b)(4) you must comply with the requirements of 314.70(c)(6)(i) regarding the submission of supplemental (b)(4) and other changes to an approved (b)(4). Aurobindo Unit I and Aurobindo Unit IX were also inspected and cited for CGMP deficiencies related to the manufacture of (b)(4) API and intermediates. It was like I took nothing. They are round off-white pills with "U30" stamped on one side. This assessment did not include an evaluation of the potential for key starting materials (KSM), other raw materials, and solvents to result in the presence of (b)(4) and (b)(4). Aurobindo Pharma USA. The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. These impurities are present in drug substances at levels exceeding the (b)(4) USP specification limit for Any other individual impurity (i.e. Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Aurobindo Pharma Limited, Unit XI, Sy. Investigators observed, in your (b)(4) API, non-carcinogenic impurities of (b)(4) and (b)(4) at levels up to (b)(4)% and (b)(4)%, respectively, in residual solvent testing for (b)(4) API batches. Join this webinar to hear experts discuss the key considerations for tech transfer and present how a customized modeling tool can help streamline the scale-up of your oral small molecule program. FDA Issues Safety Alert for JAK Inhibitor; March 4, 2019. Your Quality Unit failed to report to FDA these impurities, which were also above your internal reporting threshold limit of no more than (b)(4)%. The .gov means it’s official.Federal government websites often end in .gov or .mil. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. These impurity levels are also above the ICH Q3A(R2) reporting threshold for drug substance impurities. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). You subsequently recalled these batches. Aurobindo has had similar problems at another sterile manufacturing plant in nearby Bachupally. In addition, the inspection revealed that your firm failed to submit supplemental (b)(4) to report the pertinent specification changes in Drug Master File (DMF) (b)(4), as required by 21 CFR 314.97(a). You subsequently recalled these batches. Contact Nabeel Babaa, by e-mail at Nabeel.Babaa@fda.hhs.gov, within five business days of receipt of this letter to schedule a regulatory meeting to discuss CGMP compliance at Aurobindo Unit XI (FEI: 3004611182), Aurobindo Unit I (FEI: 3004021253), and Aurobindo Unit IX (FEI: 3006370489). As the DMF holder of (b)(4) API DMF (b)(4), we remind you that any addition, deletion, or change to the information in your DMF is required to be submitted to the FDA under 21 CFR 314.420. The company did not reply to a detailed questionnaire sent by Business Standard on the matter. NMT (b)(4)%). Our Story; AuroControl; Management Team; Corporate Offices; Research & Development ; List of Authorized Distributors; … © 2020 Questex LLC. Provide a comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of drugs for the United States. The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved. The FDA finding comes as the Indian drugmaker has significantly increased its footprint the U.S. generics market with three plants, 750 employees and a portfolio of 300 drugs it acquired in September from Novartis’ Sandoz unit for $1 billion. During our inspection, our investigators observed specific deviations including, but not limited to, the following. Your response is inadequate. While you were no longer using (b)(4) as a supplier of recovered solvent (b)(4) for the manufacture of (b)(4) at the start of the FDA inspection, you did not identify corrective actions to ensure adequate quality oversight of operations for all contractors performing functions that could affect drug quality. 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To have problems this warning letter summarizes significant deviations from current good manufacturing practice ( CGMP for! Any DMF update should also result in notifications to any authorized person for the DMF March! Produce, and l-amphetamine salts in the ratio of 3:1 FDA finds Aurobindo sterile drug plant continues have. Which is growing its reach in the ratio of 3:1 has put a generic form of drug!