Popular Hemorrhoid Drug Taining (Compound Carraghenate Suppositories) Officially Delisted After Price Surge and Supply Shortage

▍Source: CPhI China Author: Color

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First, production was halted, leading to stockouts., and thenFrom the skyrocketing price to the submission of the delisting application, the internet-famous hemorrhoid medicine Compound Carraghenates Suppository (brand name "Taining") has reached its final delisting.SuccessConclusion.

The interval from application to cancellation is nearly 2 years.

Best-selling Hemorrhoid Treatment DrugsEndDelisting

Recently, the National Medical Products Administration released information aboutAnnouncement on the Cancellation of Registration Certificates for 80 Drugs Including Loratadine Tablets.

According toCepharma has compiled a list of the drugs being deregistered, which includes several commonly used clinical medications. These cover antiallergic drug loratadine tablets, men's health medication finasteride tablets, vitamin supplement riboflavin (vitamin B2) tablets, and anorectal disease care medications such as compound carrageenate cream and compound carrageenate suppositories (see details at the end of the article).

However, these drugsAbsoluteMostCount AllNot an exclusive product, relevant enterprises' approval cancellationAlsoWithout affecting other holdingsProducts with the Same Generic Name ApprovalNormal Operation of EnterprisesProductionSalesActivity。

Among them, Compound Carraghenate Cream, Compound CarraghenateEster栓Both网红hemorrhoid drugs are "exclusive products" of Xian Janssen, meaning that after the approval numbers are revoked, the related products will eventually completely exit the market with no other products of the same generic name to replace them.

The Drug Registration Certificate is the core legal document for the legitimate circulation of drugs. Once revoked, the corresponding drug loses its qualifications for production, import, sale, and use, and shall no longer enter the market circulation.

These 80 drugs are all "deregistered upon application," according to Article 110 of the Measures for Drug Registration.In the event of any of the following circumstances, the National Medical Products Administration shall cancel the drug registration certificate and make an announcement:

AlthoughSpecific Reasons for the Cancellation of Most DrugsUnknown, but the withdrawal of some varieties had been foreseen.

As the exclusive partner of Xian JanssenProduct, Compound Carraghenates Suppositories have entered the top sales of the hemorrhoid medication market in China after their launch.V. Further inquiries by Saibailan into the Pharma Intelligence data reveal that, in the first quarter of 2025, public hospital terminals...The sales of Compound Carrageenate Suppositories amounted to 240,000 yuan.2280 in 202410,000 yuan. Data from the CMH-Kaisi system of Zhongkang shows that in the off-hospital market, from 2021 to 2023The sales of Compound Carrageenate Suppositories were respectively70 million yuan, 78 million yuan, 77 million yuan.

The eventual withdrawal of a once best-selling product is attributed to long-term challenges in raw material supply. As early as 2023, Xian Janssen clearly stated in a communication letter to customers that the main active ingredient of Compound Carrageenate Suppositories is naturally extracted and non-renewable, and there is currently no sustainable global supply of the raw material for production.Hereby, Xian Janssen will cease the supply of Compound Carraghenates Suppositories as of November 2023.And submitted a withdrawal application to the National Medical Products Administration on October 19, 2023.

The compound carrageenate suppository took nearly two years from the submission of the application to the official deregistration.

Price Soaring

What are the replacement drugs?

Raw Material Supply Disruption and Market WithdrawalOnce triggered price fluctuations in the downstream market of this product.After the withdrawal notice was issued, the price of Compound Carrageenate Suppositories increased more than 10 times, and many...Patients also use internet platformsExpressed anxiety about the medication gap.

As of October 20, CPhI China found on the JD platform that Compound Carrageenate Suppositories were still available in some stores, but at a significantly high price. The cost of a box containing 3.4g*6 suppositories ranged between 800 and 1000 yuan. Compared to the prices on the same platform on April 10, 2024, there has been a substantial increase. At that time, the price for the same specification of this medication ranged from 245 to 288 yuan (the above prices are not comprehensive statistics and may vary across different stores).

Screenshot source: JD APP

From the marketIn terms of market landscape, according to data from Menet, among the top 10 hemorrhoid traditional Chinese medicine products in China's three major terminals and six major markets in 2024, Mai Zhi Ling Tablets ranked first with a 35.56% market share, followed by Ma Yinglong Musk Hemorrhoid Ointment, Musk Hemorrhoid Suppositories, and Gang Tai Suppositories with shares of 13.44%, 7.16%, and 5.33%, respectively. Moreover, Ma Yinglong Musk Hemorrhoid Ointment and Gang Tai Suppositories achieved year-on-year growth rates of 9.60% and 10.70%, respectively.

Top 10 Hemorrhoid Chinese Patent Medicine Products in China's Three Major Terminals and Six Markets in 2024

This Year, 142 Drugs Have Canceled Their Drug Registration Certificates

Mostly "Cancellation upon Application"

Cepharma has found that, since the beginning of this year, the National Medical Products Administration (NMPA) has issued at least four batches of announcements on the cancellation of drug registration certificates, involving 142 drugs.

In June, the National Medical Products Administration canceled the registration certificates of 56 drugs, including Pediatric Electrolyte Supplementation Injection, all of which were ""Cancellation upon application."

In April, the National Medical Products Administration (NMPA) initiated post-marketing evaluations for five varieties, including An Chuan Tablets, effective immediately.Discontinue the production, sale, and use of An Chuan Pian, Clenbuterol Hydrochloride Film, Clenbuterol Hydrochloride Suppositories, Compound Clenbuterol Hydrochloride Suppositories, and Compound Hydroxypropyl Theophylline Dechlorotheophylline Capsules in China, and cancel the drug registration certificates.

The announcement also clarifies the subsequent disposal requirements: the Marketing Authorization Holder (MAH) of the drug is responsible for recalling the drugs whose registration certificates have been revoked. The recalled drugs will be supervised for destruction by the provincial drug regulatory department where the MAH is located, or other legally mandated harmless treatment measures will be implemented.

In January, the drug registration certificate for Belladonna Sulfamethoxazole Tablets was revoked, involving 80 pieces of information.

This announcement did not disclose the specific reason for the cancellation, but prior to this, the National Medical Products Administration had requested to halt the production, sales, and use of Belladonna Sulfamethoxazole Trimethoprim Tablets in China.In accordance with Article 83 of the "Drug Administration Law of the People's Republic of China" and other relevant regulations,After evaluation, drugs with uncertain efficacy, significant adverse reactions, or other reasons that endanger human health should have their drug registration certificates revoked. Drugs whose registration certificates have been revoked must not be produced, imported, sold, or used.

Belladonna Sulfamethoxazole and Trimethoprim Tablets are compound preparations, with main active ingredients including Belladonna Tincture, Sulfamethoxazole, and Trimethoprim, etc., which can be used to treat acute and chronic bacillary dysentery caused by Shigella and other enteritis caused by sensitive pathogens. This batch cancellation involves the largest number of varieties within the year.More than once。

An industry expert analyzed to Sai Bai Lan that, from the latest batch of products with revoked approvals,Some are products already included in bulk procurement, while others are products with dwindling market shares due to competition from innovative drugs, poor sales, and insufficient profits. Overall, the cancellation of drug approvals is a normal iteration within the market.

Attachment: Directory of Cancelled Drug Registration Certificates

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