Hydrochlorothiazide | Polpharma | Listed Dossiers | Finished Dosage Forms

Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland

12 Sep 2024

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Tackling N-Nitrosamines Challenge With High-Performance Instrumentation

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DATA COMPILATION
#PharmaFlow

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Website

CPhI Worldwide, Milan

Booth #3F106

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envelop Contact Supplier

DIGITAL CONTENT

3 INTERVIEW #SpeakPharma, 11 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 129 NEWS #PharmaBuzz

media
3 INTERVIEW #SpeakPharma
11 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
129 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

73 All APIs, 38 USDMF, 20 CEP/COS, 14 JDMF, 54 KDMF, 79 NDC API, 66 Listed APIs

73 All APIs
38 USDMF
20 CEP/COS
14 JDMF
54 KDMF
79 NDC API
66 Listed APIs

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

7 ALL Intermediates

7 ALL Intermediates

KEY PRODUCTS

Alendronate Sodium, Apixaban, Baclofen, Dapagliflozin, Dapagliflozin Propanediol Monohydrate, Empagliflozin, Enzalutamide, Hydrochlorothiazide, Isavuconazonium Sulfate, Linagliptin, Palbociclib, Pentoxifylline, Piracetam, Rivaroxaban, Tadalafil, Ticagrelor, Trametinib, Zoledronic Acid

Alendronate Sodium
Apixaban
Baclofen
Dapagliflozin
Dapagliflozin Propanediol Monohydrate
Empagliflozin
Enzalutamide
Hydrochlorothiazide
Isavuconazonium Sulfate
Linagliptin
Palbociclib
Pentoxifylline
Piracetam
Rivaroxaban
Tadalafil
Ticagrelor
Trametinib
Zoledronic Acid

SERVICES

API Manufacturing, API & Drug Product Development

pharmaServices
API Manufacturing
API & Drug Product Development
- 4 API Development

KEY SERVICES

Cryogenic Reactions, API Scale-Up, API Development Services, API Scale-Up Capabilities

Cryogenic Reactions
API Scale-Up
API Development Services
API Scale-Up Capabilities

INSPECTIONS & REGISTRATIONS

4 FDA, 45 EDQM, 1 GDUFA

inspections
4 FDA
45 EDQM
1 GDUFA

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

About

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

CPhI Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Booth #3F106

08-10 October, 2024

Fiera Milano, Italy
26th North American IS...26th North American ISSX

Industry Trade Show

Not Confirmed

15-18 September, 2024

Hawaii, USA
DDF Summit, USDDF Summit, US

Industry Trade Show

Not Confirmed

16-17 September, 2024

Hyatt Regency LA Jolla, San Diego

CONTACT DETAILS

Click the arrow to open the dropdown

Country

Poland

Address

Pelplińska 19, 83-200 Starogard Gdański

Telephone

+48 585631600

api@polpharma.com

Website

https://www.api.polpharma.com/

https://www.linkedin.com/company/polpharma-api/

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

“Polpharma has invested over €35 million in a new facility to handle HPAPIs”

Over the recent years, the market for contract development and manufacturing organizations (CDMOs) has been growing at a fast clip owing to a plethora of factors such as the rising demand for biologics, new trends towards personalized medicines and the need to bring new treatments to the market more quickly. This week, SpeakPharma interviews Dawid Ignatowicz, Head of Key Account Management, CDMO, Polpharma, to know how the Polish drugmaker is growing its CDMO business and some of the inherent advantages it enjoys in this landscape. Of late, there has been an increase in demand for drug substance development and cGMP manufacturing services. How is Polpharma gearing up to meet this demand? In fact, the number of drug developments has increased over the past few years. This coupled with some lack of capacity in some major European CDMO’s, potentiates good opportunities for companies like Polpharma. Over the last few years, Polpharma has been growing its offer on the CDMO, either by adding new capabilities in research and development and in production or by increasing its manufacturing standards (compliance, EHS, etc.). Our objective is to support our customers into the different phases of drug development, as such we have adapted our systems to be able to answer their requirements on the different stages – with the ultimate goal of providing a reliable, efficient, and cost-effective service to the customers. What differentiates Polpharma from other CDMOs? Our major strengths can be referred as: good project management skills (we have a group of experienced people that help the customers), transparency (since the inception of a project we have developed a clear and transparent way of communicating flow with the customer so that we can have full visibility of their project in our site), an ability to listen to our customers (a rather simple requirement, but that seems difficult to find in the market), good process design (more delivery kilos of a product we want to establish a good efficient and cost-effective process) and flexibility (we understand that development projects could have changes on the timelines and the capability to adapt to those changes is critical). Besides the above, we have a positive track record of regulatory approvals coupled with experience and expertise in filing to the FDA. We have positive pre-approval inspection audits (PAIs) that reaffirm our robust quality management system. We are known for efficient management of changes and deviations — we are both open and collaborative and work alongside our clients. Tell us about the range of CDMO projects that Polpharma handles. Owing to our decades-long experience in drug substance development, regulatory filing, and commercial manufacturing, Polpharma can support customers at various phases — from clinical supplies, through validation and launch, up to regular commercial supplies. Manufacturing highly potent APIs comes with several challenges, especially with respect to toxicity and exposure. Are you observing more projects with high toxicity? In order to address the growing demand for the development and manufacture of highly active compounds, we have invested over €35 million in a new facility to handle HPAPIs that will include process and analytical R&D, small-scale cGMP manufacturing suites and quality control (QC) labs. This facility will allow us to handle compounds with an occupational exposure limit (OEL) value down to 10 ng/m3 (or OEB6, i.e. very high contamination).

Impressions: 2588

CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

GMP Certificate 2023

High Potency API 2024

CDMO Brochure 2023

Ipochem Corporate Presentation

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Ipochem Product List 2022

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Corporate Video

Polpharma Biologics - Brand Launch Video

Ideas Make It Happen

Polpharma API, Your European CDMO Partner

DATA COMPILATION #PharmaFlow

FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim). Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015, FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 — down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira. In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.