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- 2026-05-20 09:19:25
- Policy
- Labeling will be promoted on product packaging
- by Lee, Tak-Sun Jun 04, 2020 06:14am
- In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging. In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis. The MFDS announced on the 1st that it is planning to draw the final plan through the public-private consultative body to strengthen the international competitiveness of generic drugs by this month. The public-private consultative body, which strengthens the international competitiveness of generic drugs, has been in operation since April, consisting of about 50 people from the pharmaceutical industry, academia, medical experts, patients, and consumer groups. The tasks for which the public-private consultative body came up with the final plan are: ▲ Conduct bioequivalence test, strengthen drug labeling and information disclosure ▲ Develop bioequivalence test evaluation indicators and disclose evaluation results ▲ Establish a generic drug database for each ingredient. First, among generic drugs, the number of bundled products that are entrusted and manufactured by companies that have not already conducted a bioequivalence test directly is increasing. Therefore, it is necessary to promote a method of labeling the product, such as the name of the pharmaceutical company that actually conducted the bioequivalence test. In particular, the MFDS explained that it is also considering ways to bundle generic drugs with the same bioequivalence test as a factory standard, and to disclose the information through the MFDS website and prescription preparation system. It means that bioequivalence tests are conducted on generic drugs, and products that are manufactured directly and products that have been granted product approval through consignment manufacturing are released together. The MFDS will also develop bioequivalence quality assessment indicators and disclose the evaluation results. It is a plan to increase the quality level and reliability of generic drugs by preparing quality evaluation indicators and transparently disclosing the evaluation results so that they can evaluate the quality level of generic drugs. The MFDS said that the analysis of the effect of the actual use stage after marketing, the MFDS in the bioequivalence test results indicates the ratio (The closer to 1 means the same) of the generic drug (test drug) to the original drug (control drug), the frequency of side effects after the generic drug is marketed may be an example for the quality evaluation index. In addition, the generic drug, which is manufactured by entrusting the entire process, will also clarify the responsible relationship between trustees, such as entrusting quality control obligations to consigned companies and strictly managing quality management of consigned companies. In addition, the establishment of a generic drug database for each ingredient will be promoted. In response, the MFDS will explain the current status of generics by ingredient in English so that overseas buyers and distributors can identify them to support the global advancement of generic drugs, and will also provide them to international organizations such as the World Health Organization (WHO). An official from the MFDS said, "We plan to prepare a plan to improve the specific system so that the contents under the agreement can be carried out normally in the public-private consultative body, and to prepare and announce a detailed action plan for the improvement method by the end of June."
- Opinion
- [Reporter’s view] Pharmacists are tired of impurities
- by Kim JiEun Jun 04, 2020 06:13am
- Another task has recently been added to the pharmacy. From Valsartan, Ranitidine to Metformin. This is because pharmacies have to clean up with repeated impurities situation. The Metformin situation was stopped by the sale of some items, so there was not much confusion than the previous Valsartan or Ranitidine events. However, due to the past two cases, alternative medicines showed a shortage shortly after the announcement of discontinuation. In particular, some of the drugs that have been discontinued this time have fewer drugs to replace, and alternative drugs were sold out of major online drug stores less than an hour after the announcement of discontinuation. It had a hard time for pharmacists who couldn't order medicine quickly to get out of stock. Again, pharmacists who have come into contact with the media are in chaos. They had to clear the stock of drugs that had been discontinued since the morning, and they were busy going into and out of an online mall to order a replacement drug and inquiring about the drug at a wholesale dealer. The pharmacy dispensary was filled with new medicines that were ordered immediately after the announcement of the suspension. If the demand is unpredictable and they don't know when it will be out of stock, it is best to stock up on the new drugs. Even in the case of Valsartan and Ranitidine, pharmacies with many prescription preparations had to give up pharmacy space for drugs that had been ordered in advance for several months. This is not all. The pharmacy had to respond to patient inquiries that followed immediately after the announcement. Like any pharmacist who said, "We are not wrong, we must explain and persuade the pharmacy to be wrong every time." Even in this situation, pharmacists had to explain why the drug they were taking was discontinued and how to deal with it. It is not only a problem that will end with Valsartan, Ranitidine, and Metformin in an era when impurities have emerged as a new era of drug safety management. Although the original responsibility and management of impurity medicines ultimately belongs to the pharmaceutical industry and regulatory authorities, there is an unfair aspect in the current situation where pharmacies must stand at the center of the situation whenever it happens. Of course, it is a top priority to prevent the current situation from being repeated with clear standards and strict regulations. However, as impurities have emerged as a new paradigm for drug safety management, it seems that the government will not be able to ignore the introduction of the international common name and furthermore, the introduction of ingredient names. The fact that this year is the 20th anniversary of separation of prescribing and dispensing drugs will also be a part of empowering discussions on these systems.
- Company
- 3 out of 10 executives, worries about poor performance
- by Chon, Seung-Hyun Jun 03, 2020 06:40am
- The executives working at the pharmaceutical company pointed out the poor performance after COVID-19 outbreak. Most people pointed out that the company should reduce its performance targets to minimize damage to COVID-19. On the 21st anniversary of its founding, Dailypharm conducted a survey of “Post COVID-19 Crisis Response Strategy” by 725 executives from pharmaceutical companies. Pharmaceutical executives responded to the question of what was the biggest inconvenience after the COVID-19 incident, with 228 respondents (31.4%) responding to poor performance due to face-to-face reduction. As patients are reluctant to visit medical institutions after the COVID-19 crisis, there is growing concern over the decline in prescription drug sales in pharmaceutical companies. In addition, pharmaceutical companies have expanded telecommuting since the spread of COVID-19, but concern about poor performance due to negligent account management has emerged as the biggest concern. 25% of respondents (181 people) pointed out anxiety about job cut. This means that there are many executives who are concerned about the reduction of manpower due to the restructuring due to changes in the way they work, such as expanding non-face-to-face work. Many respondents pointed out that the inefficiency of work due to telecommuting (17.9%), the strengthening of the company's surveillance and distrust of the boss (13.0%), and the deterioration of work and life balance (12.7%) due to the disappearance of the boundary between work and privacy were uncomfortable. Regarding the cost reduction plan to minimize the damage to COVID-19, 65.1% (472 people) of the pharmaceutical executives answered that they adjusted their sales amount such as lowering their targets. In COVID-19 crisis, it is the view that, in a situation where the economic recession is realizing, the crisis must be overcome by adjusting the company-wide goals. 8% (203) answered that they should cut costs by reducing operating expenses such as salary or marketing expenses. Over 10% of respondents said that they should consider reducing manpower (13.8%) and reducing investment (11.2%). Pharmaceutical executives agreed with COVID-19 to break away from traditional business methods. Regarding the direction of reorganization of sales and marketing strategies in the post-corona era, 40.3% (292 employees) of pharmaceutical companies said that they should strengthen online sales and marketing. As a result of the COVID-19 crisis, it is recognized that shrinking face-to-face sales and activating non-face-to-face sales are required, and strengthening IT-based face-to-face sales strategies is essential. 29.8% (216 people) said that it is necessary to find marketable products. Pharmaceuticals executives recognized that post-corona era workforce restructuring is expected. 61.1% (443) responded to the question that asked about opinions on the decline in jobs in the pharmaceutical industry after the COVID-19 crisis. In fact, 14.6% of executives predicted that the jobs in the pharmaceutical industry would drop significantly. 57% (413 people) said that the number of sales jobs would decrease the most. Also, 28.7% of respondents predicted that jobs would be reduced in office work such as personnel and management, which is expected to shrink due to the activation of non-face-to-face work. In the post-corona era, 40.1% of the respondents said that jobs in online IT-based jobs would increase. Also, 22.6% of respondents pointed to the expansion of marketing jobs. Pharmaceuticals executives also expressed negative views on the reorganization of the business method in the post-corona era. When asked whether to reduce face-to-face operations after COVID-19, more than half, 54.5% (395) said they could do as before. Although socially reluctant to face-to-face business, there are many conservative views that meeting with a doctor or pharmacist and conducting sales activities is more helpful for performance. According to the survey, 38.8% of respondents said that face-to-face sales should be reduced. About half of the executives (50.9%) predicted that the pharmaceutical industry would settle for telecommuting or flexible work. In the post-corona era, the reorganization of the way of working is a demand of the times. The employees of pharmaceutical companies expected that telecommuting or flexible work would increase work efficiency. 44.1% of respondents said that telecommuting or flexible work would improve work efficiency. This data is the result of a survey conducted by Dailypharm on 725 executives of pharmaceutical companies.
- Company
- Cancer Committee to review 3 signature drugs by BMS-Celgene
- by Eo, Yun-Ho Jun 03, 2020 06:25am
- On June 3, the Cancer Deliberation Committee is to review granting coverage on key products by the combined company of Bristol Myers Squibb (BMS) and Celgene. Celgene’s multiple myeloma pipelines—Revlimid (lenalidomide) and Pomalyst (Pomalidomide)—and BMS’ immunotherapy Opdivo (nivolumab) plus Yervoy (ipilimumab) combination are on today’s agenda. Revlimid and Pomalyst each targeting different goals Revlimid, despite the Cancer Committee deferring the drug in last September, is trying the committee again with coverage extension as a maintenance therapy to prevent relapse in patients who had stem cell transplantation. Unlike last time, Celgene has apparently prepared more accommodating financial solution to offer. From a financial standpoint, Revlimid’s maintenance therapy does not strain NHI so much. Research data claims a patient who did not receive maintenance therapy after the transplantation comes to initiate the second-line therapy quicker than the patients who have. And the following second-line therapy uses at least two drugs combined, but the U.S. National Comprehensive Cancer Network (NCCN) guideline and European Society for Medical Oncology (ESMO) recommend triple therapy including Revlimid. The recommended triple therapy is a combination of comparatively high-cost drugs like Revlimid, Kyprolis (carfilzomib), Empliciti (elotuzumab), Ninlaro (ixazomib) and Darzalex (daratumumab). Technically, using a single therapy for maintenance to delay the relapse would ultimately delay the high-cost triple therapy. Moreover, the already-reduced pricing of off-patent Revlimid would be additionally reduced when the reimbursement is extended to cover the maintenance therapy. Pomalyist, on the other hand, has applied for coverage review as a second-line therapy, in addition to its coverage on third-line therapy. The committee would review the combination therapy consisting of Pomalyst, Velcade (bortezomib) and dexamethasone for patients with multiple myeloma, who have previously received one or more treatment including Revlimid. Opdivo and Yervoy combination therapy tries renal cell carcinoma treatment Opdivo is focusing on a combination therapy with Yervoy. During the April Cancer Committee meeting, the reimbursement on Opdivo has been cleared for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy have failed. But the committee would review Opdivo as a first-line therapy for renal cell carcinoma. Ono Pharmaceutical and Opdivo have technically given up on reimbursement on the non-small cell lung cancer indication after having a preliminary meeting with the government in May last year. But now the company has shifted its focus to different indications. At the moment, Sutene (sunitinib), Nexavar (sorafenib) Torisel (temsirolimus), Votrient (pazopanib) and Avastin (bevacizumab) are available for first-line treatment in patients with renal cell carcinoma, but the reimbursement is granted when choosing one among all options except for Avastin. The CheckMate-214 study has confirmed the Opdivo plus Yervoy combination therapy significantly improving the overall survival of the participating patients regardless of PD-L1 expression against the sunitinib group.
- Policy
- The MFDS designated Mobocertinib as an orphan drug
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The MFDS (Minister Eui-kyung Lee) announced that Mobocertinib was newly designated as an orphan drug, and it announced on June 1 that target diseases were added for three types, such as Ipilimumab, designated as an orphan drug. An orphan drug is a drug that is used for the purpose of diagnosing or treating a rare disease, a drug that has no or no substitute drug, or is significantly improved in safety or effectiveness than a substitute drug, and has been designated by the MFDS. In order to support the development of treatments for rare and incurable diseases, the MFDS firstly authorizes orphan drugs and operates 'Orphan drug designation system' so that it can separately set data, standards, and conditions for approval according to the nature of the disease. The main announcement of this orphan drug designation was that Mobocertinib was designated for the treatment of patients with non-small cell lung cancer with epidermal growth factor receptor mutation, and Ipilimumab has been further designated for use in recurrent metastatic colorectal cancer in adult patients with DNA mismatch repair defects, etc. Also, Ixazomib was added to maintenance therapy of patients with multiple myeloma who received autologous hematopoietic stem cell transplantation, and Ravulizumab was added as a treatment for patients with atypical hemolytic uremic syndrome. Atypical Hemolytic Uremic Syndrome (aHUS) is a disease that occurs in blood clots in blood vessels, interferes with blood flow, destroys red blood cells, and causes hemolytic anemia. An official from the MFDS said, "The orphan drug designation is expected to help in the development of treatments for people with rare and intractable diseases., and will continue to develop policies to ensure patient care opportunities in the future."
- Company
- AbbVie’s psoriasis drug Skyrizi NHI listed from June 1
- by Eo, Yun-Ho Jun 03, 2020 06:25am
- Another interleukin inhibitor has been listed for National Health Insurance (NHI) reimbursement. AbbVie Korea announced the Korean health authority is providing healthcare reimbursement on severe psoriasis treating interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving photochemotherapy or UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. Psoriasis is an immune-mediated disease resulted by abnormal activity of the body’s immune system. The disease causes a red, peeling rash spreading across the body. Apparently, patients with moderate to severe level of psoriasis, whose 10 percent of body surface area is covered with the rash and exfoliated sheets of skin, mentally suffer from other people’s social bias and misunderstanding as an infectious disease. According to data disclosed last year by National Health Insurance Service (NHIS), approximately 160,000 people in Korea have visited hospital in last five years due to psoriasis, and 20 percent of those people, or about 30,000, are struggling with severe case of psoriasis. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been remained even after a year.
- Policy
- Handok takes over Eisai’s Aricept license from Daewoong
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The Korean market license for the dementia treatment market leader Aricept (donepezil) has been transferred from Daewoong Pharmaceutical to Handok. Except for a few items, Handok is to manufacture the treatment in Korea. Daewoong Pharmaceutical has been importing active ingredient from a Japanese-based pharmaceutical company Eisai that developed Aricept and manufactured and supplied the finished product. Eisai Korea is in charge of the sales. On May 29, a pharmaceutical industry source reported Handok recently took over the Aricept license from Daewoong Pharmaceutical. The rights over five items including Aricept Evess 10 mg tablet, Aricept Evess 5 mg tablet, Aricept 10 mg tablet, Aricept 23 mg tablet and Aricept 5 mg tablet have been handed over. Daewoong Pharmaceutical would be the cosigned manufacturer of Aricept 5 mg tablet and Aricept 10 mg tablet, while Handok manufactures the rest. Meanwhile, Eisai Korea would maintain the license over Aricept 5 mg ODF and Aricept 10 mg ODF. Since the first approval won in 2000, Aricept’s license in Korea has remained with Daewoong Pharmaceutical. The partnership deal assigned the manufacturing to Daewoong Pharmaceutical and the sales to Eisai Korea. However, a slight change occurred in the deal as Eisai has decided to ink a joint sales deal with Chong Kun Dang. And now the license has been transferred from Daewoong Pharmaceutical to Handok. Technically, the shift in license ownership means Deawoong Pharmaceutical has ended the close relationship it had with the original Aricept. Regardless, the Korean company already owns a donepezil generic Dimenpezil tablet, which five items under the brand name so far have received approval since 2018. On the contrary, Handok with the new deal would expand its revenue source. According to pharmaceutical market research firm IQVIA, Aricept has generated 65.6 billion won last year. Eisai Korea’s official statement informed the pharmaceutical distribution industry of Aricept labeled with the new Handok product code valid from June 1, due to the change in manufacturer. Eisai also explained the healthcare reimbursement on Daewoong Pharmaceutical-manufactured Aricept products can be claimed until Nov. 30, 2020.
- Company
- 'Champix' sales rebounded 13% in one year
- by Kim, Jin-Gu Jun 03, 2020 06:25am
- ChampixPfizer's anti-smoking supplement Champix (Varenicline) has been successful in rebounding sales. It increased by 13% compared to the first quarter of last year. It is an analysis that it benefited from winning the patent dispute with generics. According to the drug analysis agency IQVIA on the 29th, the sales of Champix in the first quarter was ₩6.9 billion. This is a 13% increase from the first quarter of 2019, compared to ₩6.1 billion. In terms of quarterly sales, it has increased significantly since the second quarter of last year. It is analyzed as the result of winning the patent dispute with generics. Champix' salt modified drug was first released in November 2018. However, when the supreme court ruled in January 2019 that patent evasion of salt-modified drug was illegal in Solifenacin formulations, most of them were discontinued. In December of the same year, for the same reason as the judgment of Solifenacin, it was illegal to release the drug before changing the substance patent for the Champix salt modified drug. As a result of this ruling, domestic pharmaceutical companies' marketing has been suspended. However, from 3Q this year, it will resume competition with generics. This is because the material patent of Champix will expire on July 19th. This is because it is possible to re-engage generics that have previously avoided or invalidated the salt patent of Champix. It is estimated that 37 pharmaceutical companies are waiting for patent expiration with 85 items on the 29th. In addition, the application for permission to change salts has recently increased. Since January of this year, there have been a total of 12 items for the application of permission to change salts for Champix. Champix quarterly sales trend (₩100 million, data IQVIA) Although Champix sales rebounded, they haven't recovered to the extent of regaining the glory of the past. Champix once had quarterly sales of ₩21.4 billion (first quarter of 2017). Compared to that time, it is only a third. This is because the number of participants in the anti-smoking support project has steadily decreased and the drug price has been cut by nearly 40%. In November 2018, the NHIS lowered the drug price from ₩1,800 to ₩1,100.
- Policy
- MFDS & FDA have different NDMA’s follow-up measures
- by Lee, Jeong-Hwan Jun 02, 2020 09:13pm
- The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin. The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the full recovery of items before the detection of impurities exceeding the standards, but FDA did not enforce the prohibition of sales other than the recovery of the existing distribution volumes. Some pharmaceuticals explain that there are aspects that minimize damage to the pharmaceutical industry through delicate regulation. In particular, about the cause of NDMA detection, the MFDS ordered the pharmaceutical companies to submit a compulsory order within three months, but the FDA also cooperated with the pharmaceutical company to find the cause of detection. .According to the pharmaceutical industry on the 1st, 22 pharmaceutical companies that detected NDMA above the reference level in Metformin are in the voluntary recovery process according to the recommendation of the MFDS .Nonetheless, the pharmaceutical industry is focusing on the differences between the MFDS and the FDA in responding to the NDMA crisis .22 companies holding 31 items that have been confirmed to have exceeded the standard have been affected by the withdrawal of their drugs from the pharmaceutical prescription market since The items detected by the MFDS were recovered and production·sale suspensions were announced on the 25th of last month .Compared to Valsartan or Ranitidine in the past, the number of items was small, so the damage to the entire pharmaceutical industry was minimal, but pharmaceutical companies such as JW Pharma and Hanall, which sold about ₩10 billion a year as a single item, were barred from selling for a day .So how did the MFDS and the FDA take other follow-up measures ?The MFDS, instructed the pharmaceutical company to verify the NDMA detection drug manufacturing process The MFDS went through the review of the Central Pharmaceutical Affairs Review Committee and announced further restrictions on the manufacture, sale and prescription of Metformin exceeding its own standards .It is mandatory to submit manufacturing process verification data that NDMA is no longer detected in the company's Metformin within 3 months until August 31 .Specifically, ▲ Process variables that can affect NDMA production ▲ NDMA generation possibility review data due to the effect between Metformin and other ingredients (main ingredients and other additives) ▲ Storage conditions tests such as acceleration and harshness and packaging and container review ▲ Preventive and corrective measures to prevent NDMA from occurring in the manufacturing process in the future or to be adjusted within the maximum allowable capacity per day ▲ Variability of NDMA detection between manufacturing numbers is the scope of verification data .As a result, 22 pharmaceutical companies were forced to focus on making NDMA process data along with recovering the total amount of their medicines scattered at the prescription sites such as medical institutions and pharmacies .It has long since been removed from physician's prescribed list .This is because the patient's sensitivity to NDMA is greatly increased, and sales are immediately banned .FDA has taken the lead in identifying the cause .Inspection by batch prior to manufacturing and sales ban. The pharmaceutical industry claims that unlike the MFDS, the FDA began to work with pharmaceutical companies to determine the cause, when and where NDMA was detected .In particular, even for items that detect impurities above the reference level, the pharmaceutical system view that FDA decides to recover the total amount of the existing distribution volume, while allowing subsequent distributions to be distributed immediately after the NDMA inspection before shipment rather than immediately stopping manufacturing and sales .In fact, according to a press release issued by the FDA on Metformin’s NDMA, the FDA ordered all Metformin to be tested for NDMA exceedingly, and each batch was individually inspected before shipment to the market, so that it would not be regulated for manufacturing and sales below the reference value .FDA has instructed not to market and report the detection of excess detection only for batches that exceeded the acceptance threshold .There is no immediate sale ban except voluntary recovery, even if NDMA is excessively detected in the collected items .Experts argue that these regulatory differences affect the pharmaceutical industry .It is explained that NDMA detection will result in market exit because the drug will be removed from the market immediately if the sale is prohibited due to excessive detection .In response to this, there is an opinion that the MFDS, like the FDA, requires a delicate regulation to prohibit the sale of detection batches by mandating NDMA inspection for each batch of Metformin for excess detection items .An official from the pharmaceutical industry said, "Unlike the MFDS, the FDA allows NDMA-detected items to be shipped consistently after inspection by batch .The items announced by the MFDSy have already been withdrawn from the prescription market .As a pharmaceutical company, the damage is severe .The official said, "If the MFDS applied batch-by-batch regulations like the FDA, 22 pharmaceutical companies would not have been accused of damaging prescription sales or immoral pharmaceuticals from the public." "The regulatory gap created by the FDA's recognition of the possibility that NDMA could be over-detected at any time and in any drug."
- Policy
- Janssen to import Ultracet as Hyangnam factory closes
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- As Janssen Korea is closing down its Hyangnam factory next year, the locally manufactured pain reliever Ultracet fast-acting tablet (acetaminophen plus tramadol hydrochloride) would be imported, instead. However, the extended release tablet form of the drug, developed in Korea, would be manufactured by Handok. A pharmaceutical industry source reported that the Ministry of Food and Drug Safety (MFDS) has approved the imported Ultracet tablet on May 21. The imported tablet is manufactured in Janssen’s factory in Italy. It shares the same substance and dose as ‘Ultracet Tablet Janssen Korea’ approved in Korea in 2001 for export. The company explained, “The fast-acting tablet would be imported as the Hyangnam factory would be shut down.” However, Handok is apparently taking over the manufacturing license over Ultracet extended release (ER) tablet and Ultracet semi-ER tablet, which were developed by Janssen Korea in 2010 and 2012, respectively. The two drugs release the effect slower than the fast-acting tablet, which reduce the dosage regimen. The company official commented about the extended release tablet and said, “It is unclear when the manufacturing transfer would be completed.” So far in the year, Janssen Korea has announced Invega ER tablet, Topamax springkle capsule and Jurnista slow release tablet would be imported, instead of locally manufacturing them in Hyangnam factory. In 2018, Janssen Korea has announced the Hyangnam factory would stop operating in 2021. The factory was opened in 1983.
