The main business of Hainan Puli Pharmaceutical Co.
, Ltd.
is drug research and development, registration, production and sales; The company's main products are desloratadine dispersible tablets, desloratadine dry suspension, desloratadine tablets, diclofenac sodium enteric-coated sustained-release capsules, clarithromycin sustained-release tablets, levofloxacin hydrochloride capsules, azithromycin for injection, azithromycin dry suspension, trimebutine maleate tablets
.
On January 16, Pulsi Pharma announced that bivalirudin for injection received marketing authorization
issued by the Department of Pharmacy of the Israeli Ministry of Health.
Bivalirudin is a synthetic anticoagulant approved for the treatment of adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI); Treatment
of adult patients with unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) with planned emergency or early intervention.
Receipt of marketing authorization from the Department of Pharmacy of the Israeli Ministry of Health marks the qualification of Puli Pharma's bivalirudin for injection to be marketed in Israel
.
It is understood that after the successful research and development of bivalirudin for injection, Puri Pharmaceutical's generic drug registration applications in Europe, China, the United States and the United Kingdom and other countries and regions have been submitted to the registration application of generic drugs in Europe, China, the United States and the United Kingdom, which belong to collinear production varieties, and have been approved
by the Dutch Drug Evaluation Commission, the German Federal Drug and Medical Devices Agency and other institutions.
On January 16, Puli also said on the investor interactive platform that the company currently has more than 150 varieties under development, involving first generic + challenging patent generic drugs, improved new drugs 505b(2) and new physical compound new drugs
.
It is reported that in addition to the approval of bivalirudin for injection in Israel, on January 8, Plley Pharma also announced that the company received marketing authorization
for ganciclovir for injection issued by the Danish Medicines Agency.
Puli said that the acquisition of the marketing authorization marks that Puli has the qualification to sell ganciclovir for injection in Denmark, which will have a positive impact
on the company's expansion into the Danish market.
At the same time, the company's registration of ganciclovir for injection in other markets is continuing to advance
.
Puri Pharma continues to increase its expansion in overseas markets, and it has said on the investor interactive platform that it has signed regional exclusive sales contracts with many distributors in more than 20 countries and regions such as the United States, Germany, and the United Kingdom, opening the way for the export of the company's preparations and forming an international industrial layout
.
In terms of international sales, the company has more than 20 varieties of injections and solids approved for marketing in many countries in Europe and the United States, and the products have been successfully sold to the United States, Germany, France, the Netherlands, the United Kingdom, Canada and Australia and other countries, and the company has initially formed an international pattern
of manufacturing in China and global sales.
In the face of future development, recently, Puli Pharma said in an institutional survey that in the face of the window of change in the pharmaceutical industry, Puli Pharma will adhere to the short-term, medium-term and long-term strategies since its listing, and take the advanced manufacturing positioning
of "differentiation + vertical integration of raw material preparations + internationalization".
It said that generic drugs are still the basic plate of Prley, and the company should take into account the quantity and quality of generic drugs, and will pay more attention to the differential declaration of generic drugs in 2023, and it is expected that generic drugs will show results in 2023
.
In addition, in terms of innovative drugs, Puli Pharma said, (1) adhere to boron drugs, continue to declare generic drugs and layout innovative drugs in 2023, boron drugs have made great breakthroughs in the past year, generic drug raw materials, innovative drug PCC has been completed
.
(2) Pay attention to nucleic acid drugs, CDMO runs through it
.
Innovative drugs adhere to the Sino-US double report, the integration and internationalization of raw material preparations, and the communication between the two innovative drugs US FD is smooth, and the development of innovative drugs is still in the early stage
.
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