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Phyton Biotech to attend CPHI China in Shanghai

12 Jun 2024

// PRESS RELEASE

Phyton Biotech’s Head of Cell Culture Developt will present 2024 World Congress

09 Jun 2024

// PRESS RELEASE

Phyton Biotech attends BIO International Convention 2024

06 Jun 2024

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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CPhI Japan

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 7 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 48 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
7 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
48 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

4 All APIs, 3 USDMF, 4 CEP/COS, 2 JDMF, 2 EU WC, 6 KDMF, 3 NDC API, 2 Listed APIs

4 All APIs
3 USDMF
4 CEP/COS
2 JDMF
2 EU WC
6 KDMF
3 NDC API
2 Listed APIs

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

KEY PRODUCTS

Docetaxel, Paclitaxel

Docetaxel
Paclitaxel

SERVICES

API Manufacturing, API & Drug Product Development

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

REF. STANDARDS & IMPURITIES

21 Others

otherProducts
21 Others

INSPECTIONS & REGISTRATIONS

8 FDA, 1 EDQM, 1 GDUFA, 6 Others

inspections
8 FDA
1 EDQM
1 GDUFA
6 Others

Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

About

Phyton Biotech, a division of DFB Pharmaceuticals, was founded in 1990. Using its Plant Cell Fermentation (PCF) technology, Phyton Biotech is currently the world’s largest producer of high-quality paclitaxel and docetaxel. It offers clients a full range of integrated contract product and process development and commercial manufacturing services across the entire development chain, from feasibility to commercial production, to the pharmaceutical, cosmetic, agricultural and food ingredient industries. Its facilities in Germany and Canada have been inspected by multiple regulatory agencies and comply with international GMP requirements.

DCAT WeekDCAT Week

Industry Trade Show

Not Confirmed

17-20 March, 2025

New York, USA
CPhI JapanCPhI Japan

Industry Trade Show

Attending

09-11 April, 2025

Tokyo, Japan
SynBioBetaSynBioBeta

Industry Trade Show

Attending

05-08 May, 2025

San Jose Convention Center, CA

CONTACT DETAILS

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Country

Canada

Address

1503 Cliveden Avenue, Delta, BC V3M 6P7

Telephone

+1 6047772340

api@phytonbiotech.com

Website

https://phytonbiotech.com/

https://www.linkedin.com/company/phyton-biotech

YouTube

https://vimeo.com/user103692697

Digital content

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INTERVIEW #SpeakPharma

"Our PCF technology allows us a minimal environmental footprint while ensuring a sustainable supply of drugs"

This week, SpeakPharma interviews Jackie Labbe, Vice-President, Sales & Marketing, Phyton Biotech, a global supplier of high-quality active pharmaceutical ingredients (APIs) made through plant cell fermentation (PCF). Paclitaxel and docetaxel are both taxanes. The two APIs have historically been derived from Pacific yew trees, and are used in the treatment of cancer. In the interview, Labbe talks about Phyton’s PCF technology, and how its scalability makes it a cost-competitive and sustainable alternative to traditional extraction manufacturing processes. — What is plant cell fermentation technology? How do you use it to make biotech APIs? And how is this technology cost-competitive? Plant cell fermentation (PCF) technology is the ability to use plant cells to make active chemical compounds that are typically extracted from plant biomass. Phyton uses this technology to produce various active pharmaceutical ingredients (APIs), while assuring a sustainable supply chain that does not depend on variations in climatic conditions, and also doesn’t lead to an exploitation of precious natural resources. The technology is scalable, while also being cost-competitive. Using our PCF technology, we produce various cancer-fighting molecules like paclitaxel and docetaxel. Recently, we also entered into partnerships to develop various other compounds to ensure a sustainable supply of many new chemical entities. Since PCF technology is scalable, Phyton is able to expand production as and when required. This way, it is able to take advantage of economies of scale when our demand increases. The scalability of the PCF technology, along with its lack of dependence on the natural plant raw materials, makes it a cost-competitive alternative to traditional extraction manufacturing processes. — How has PCF helped overcome the supply chain challenges of taxanes and other natural products? Over the years, the growing demand for taxane APIs created significant pressure on the yew trees from which a key building block of these APIs had historically been derived. The over-exploitation of natural resources got to a point where trade of the Himalayan yew species was severely restricted. Phyton Biotech developed and applies sustainable and “green” chemistry manufacturing solutions for phytochemicals using PCF, which now serve the pharmaceutical as well as the traditional Chinese medicine (TCM), cosmetic, agricultural and food ingredient industries. By utilizing our revolutionary PCF platform, we are able to offer a time, risk, and cost-balanced path to commercially viable production processes. With certified GMP facilities in Germany and Canada, Phyton combines highly developed technology and quality that meets the needs of its global customers. We have a successful track record of developing and implementing innovative contract development solutions for clients around the world. Since Phyton has a yew tree cell bank, the company has complete control over the key starting ingredient. This allows Phyton to function independent of cost fluctuations that may be attributed to starting ingredients used in traditional paclitaxel manufacturing process. The same principle applies to other natural products developed via PCF. — Tell us a little about the history of taxanes. The history of taxanes dates back to 1962, when a bark from the Pacific yew tree (Taxus brevifolia), was collected as part of the US National Cancer Institute (NCI) natural products screening program. Samples derived from this bark showed cytotoxic effects and it was not until 1977, when the NCI was able to confirm anti-tumor activity in mouse models. The active molecule was paclitaxel. It later became available under the brand name Taxol. Subsequent research has shown that taxanes worked in a completely different way from other cytotoxic drugs. Paclitaxel is now included on the World Health Organization’s Model List of Essential Medicines. While initial commercial production of paclitaxel was achieved through direct extraction from the Pacific Yew, over time it became possible to manufacture the API using a precursor of paclitaxel, 10-deacetyl baccatin III, which was more widely available. In December 1992, the FDA approved Taxol for the treatment of ovarian cancer. — What are some of the regulatory challenges you face? And how are you able to comply with the regulatory standards and GMPs? Our paclitaxel is produced according to good manufacturing practices (GMPs) from the moment we remove a vial containing plant cells from the cryobank for production. GMP is continued all the way through the fermentation and purification process, and until it is shipped to our customers as a finished API. Both our paclitaxel and docetaxel are produced according to the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) and our manufacturing facilities have been inspected and approved by all the leading global health authorities. Our APIs are also supported with Drug Master Files and Certificates of Suitability and we have successfully demonstrated to regulators the consistently high quality of our products. — What are your future plans? How do you plan to take the PCF technology forward? Our aim is to expand the number of products produced by applying our plant cell fermentation to products in niche markets across pharmaceutical, traditional herbal medicines, food and nutrition and cosmetics. — In a world where sustainable supply of drugs is a big challenge, how can PCF help? Excellent question. As you are aware, we are the global leaders in specialty fermentation, with the knowhow, expertise, and infrastructure to develop, scale up, and commercially manufacture phytochemicals and recombinant proteins via plant cell fermentation. PCF is definitely one of the ways to produce some drugs sustainably because the source of the active ingredient is produced independent of plant biomass. As I mentioned before, PCF is scalable, so our entire production can be scaled up or down as needed with very minimal effort. This characteristic of our PCF technology makes us have a minimal environmental footprint while ensuring a sustainable supply of drugs that are cost-competitive.

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

GMP Certificate 2023

Contract Development and Commercial Manufacturing Capabilities

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Supply Solutions via PCF® Technology

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China’s NMPA Approval for Phyton's Paclitaxel API

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Plant Cell Fermentation by Phyton Biotech

DATA COMPILATION #PharmaFlow

Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17 13 37 Taiwan 9 6 5 4 24 Switzerland 15 4 4 23 France 16 6 22 Japan 18 1 19 United Kingdom 12 1 2 15 Mexico 9 1 1 11 Ireland 5 5 1 11 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years.