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New services offered by PMC Isochem

06 May 2024

// PHARMAEXCIPIENTS

Welcome to the exciting world of innovation!

01 Dec 2023

// PRESS RELEASE

PMC Isochem – Your partner for Smart & Innovative Solutions

07 Sep 2022

// PHARMAEXCIPIENTS

DATA COMPILATION
#PharmaFlow

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DIGITAL CONTENT

1 Vlog #PharmaReel, 9 Corporate Content #SupplierSpotlight, 2 Company Bio #AboutSupplier, 2 Data Compilation #PharmaFlow, 23 News #PharmaBuzz

media
1 Vlog #PharmaReel
9 Corporate Content #SupplierSpotlight
2 Company Bio #AboutSupplier
2 Data Compilation #PharmaFlow
23 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

42 All APIs, 20 USDMF, 9 CEP/COS, 1 JDMF, 4 KDMF, 6 NDC API, 1 VMF, 28 Listed APIs

42 All APIs
20 USDMF
9 CEP/COS
1 JDMF
4 KDMF
6 NDC API
1 VMF
28 Listed APIs

INTERMEDIATES

86 All Intermediates

86 All Intermediates

KEY PRODUCTS

Dasabuvir Sodium, Econazole Nitrate, Elbasvir, Glecaprevir, Grazoprevir, Nefopam Hydrochloride, Ombitasvir, Paritaprevir, Pibrentasvir, Ritonavir, Ubrogepant, Vitamin E TPGS API, Vitamin E TPGS Excipient

Dasabuvir Sodium
Econazole Nitrate
Elbasvir
Glecaprevir
Grazoprevir
Nefopam Hydrochloride
Ombitasvir
Paritaprevir
Pibrentasvir
Ritonavir
Ubrogepant
Vitamin E TPGS API
Vitamin E TPGS Excipient

SERVICES

API Manufacturing, Drug Product Manufacturing, Analytical, API & Drug Product Development

pharmaServices
API Manufacturing
Drug Product Manufacturing
- 1 Technologies
Analytical
- 2 Analytical Method Development
API & Drug Product Development
- 2 Formulation Development
- 5 API Development

EXCIPIENTS

4 Listed Products

excipientPortfolio
4 Listed Products

KEY EXCIPIENTS

ISODEL® Vitamin E TPGS (Tocophersolan)

ISODEL® Vitamin E TPGS (Tocophersolan)

EXCIPIENTS BY INGREDIENTS

Tocophersolan, alpha-Tocopheryl Linoleate, Polyglutamic Acid Sodium, Acetyl-DL-Tryptophane

excipientsByIngredients
Tocophersolan
alpha-Tocopheryl Linoleate
Polyglutamic Acid Sodium
Acetyl-DL-Tryptophane

EXCIPIENTS BY APPLICATIONS

Thickeners and Stabilizers, Topical, Emulsifying Agents, Film Formers & Plasticizers, Solubilizers

excipientsByApplications
Thickeners and Stabilizers
Topical
Emulsifying Agents
Film Formers & Plasticizers
Solubilizers

INSPECTIONS & REGISTRATIONS

7 FDA, 23 EDQM, 1 GDUFA, 2 Others

inspections
7 FDA
23 EDQM
1 GDUFA
2 Others

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

About

PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipients for pharmaceutical and personal care companies worldwide. Its business includes research, product and process development, pilot-scale, industrial production and regulatory approvals support. It adds value to its clients' intellectual property through constant innovation in manufacturing techniques throughout the product life cycle. PMC Isochem's facilities are located within 60 miles of Paris and are all US FDA-audited plants.

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CONTACT DETAILS

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Country

France

Address

32 rue Lavoisier - 91710 VERT LE PETIT

Telephone

+33 0164990300

genericapi@pmcisochem.fr

Website

https://pmcisochem.fr/

https://www.linkedin.com/company/pmc-isochem

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Digital content

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VLOG #PharmaReel

🎥Your Partner For Smart Custom Manufacturing

Impressions: 892

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

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Corporate Presentation

Analytical Services

Drug Delivery Services

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Isodel® Vitamin E TPGS

GMP Certificate 2024

PAA Polymers

Vitamin E TPGS Excipient

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.

Impressions: 13433

Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.

Impressions: 2500

COMPANY BIO #AboutSupplier

Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.

Overview of PMC Isochem's polyamino acid (PAA) based polymers, polymer conjugates, polypeptides, polyamides for drug delivery on PharmaCompass.What are polyamino acids and PAA-based drug delivery systems?A polyamino acid, sometimes also called a polypeptide, is a synthetic biopolymer made from amino acid monomeric units. Polyamino acids (PAAs) are comparable to proteins (and peptides) as they are also composed of amino acid building blocks linked by means of amide bonds. Structural and functional proteins, polypeptides, peptides and polymers derived from amino acids are called polyamino acids. Polyamino acids have several biological applications in tissue engineering, regenerative medicines and drug delivery systems, etc.Additionally, polyamino acids are endowed with remarkable biological functionalities, such as a target-specific delivery and rapid metabolization of their degraded products. The hydrophilicity of the amino acids influence the degradation rates of polyamino acids. The most important polyamide homo- and copolymers that are widely used in drug delivery are poly(amidoamine), polylysine, polyaspartic acid and poly(glutamic acid). Novel polymer-based drug delivery systems are being developed to change the physicochemical and pharmacokinetic characteristics of drug molecules for controlled delivery. The capability to enable unique and highly-targeted biological functions make proteins and peptides ideal candidates for drug delivery systems. The advantages of using Polyamino acids or polyamide polymer as a drug delivery system include localized target-specific delivery, biocompatibility, biodegradability, flexible physicochemical modification, slow degradability, sustained release and stabilization. Polyamino acids are widely utilized in the formulation of chemotherapeutics to achieve selective drug delivery for the right amount of time, which will reduce drug-related adverse effects and boost anti-tumor efficacy.What are the applications of polyamino acids based delivery?Poly(amino acid)s are the most commonly used polyamides in drug delivery. The use of peptides as carriers of nucleic acids for controlled delivery into target cells and organelles is one significant application of such functional materials. There are various other applications of polyamino acids which are as follows:- Poly(amino acid)s are utilized in a variety of medical and biological applications including cell adhesion, drug delivery, gene therapy, diagnostic, oncology, antibacterial, antifungal and surface chemistry.- Polyamino acids-based delivery systems have highly attractive material properties such as biodegradability, non-cytotoxicity, and mechanically durability. Natural polyamino acid (PAA) has been widely utilized in the controlled delivery of drug, protein and gene because of its excellent biocompatibility.- Polyamino acid based delivery is frequently utilized in targeted drug delivery and controlled drug delivery. Polyamino acids deliver a therapeutic to a targeted area through site-specific interactions, exploit transmembrane transport systems and deliver a therapeutic payload to a targeted site, devoid of side effects.- Water-soluble drug-polymer conjugates offer benefits such as enhanced drug pharmacokinetics and pharmacodynamics, minimal toxicity to essential organs, non-immunogenicity, tissues or cells and improved drug buildup at the target site to enhance targeted drug delivery via carrier-based systems.- Poly(amino acid)s are the first class of biomaterials and have biomedical applications because of which they are used as nonviral gene delivery vectors. Therefore, the design and synthesis of polyamino acid vectors are of great interest.- Microscale carrier is an important component of the drug delivery system that enables it to be well designed for enhancing the pharmacological and therapeutic features of drug administration.- Poly(amino acid)/polypeptide as functional materials have a variety of features like stimuli-responsive, self-assembling, nano-scale and self-healing- Silk is a structural protein that exhibits properties of self-assembly, mechanical toughness, processing flexibility, biodegradability & biocompatibility, making it extremely useful for several human therapeutic interventions.What are the different methods of synthesis of polyamino acids?In the field of sustainable chemistry and materials engineering, there is a growing interest in the development of an engineered biopolymer, such as a biomass-derived polyamide. Materials made of polyamino acids (PAAs) have attracted a lot of attention in the field of biomedicine because of their exceptional biocompatibility and biodegradability.Current synthesis techniques that are used to synthesize a biopolymer like a polypeptide and polyamino acid, such as solid-phase peptide synthesis and recombinant DNA techniques, still have problems with their production capacity, atom economy and sequence regulation. It is important to closely regulate the molecular weight within a narrow range when synthesizing polyamino acids (PAAs) for drug delivery and biomedical applications.Polypeptides are derived from the ring-opening polymerization of alpha-amino acid N-carboxyanhydrides (NCAs). Chemo-enzymatic synthesis can be used for the synthesis of polyamino acids. It is one possible option for the efficient synthesis of poly(amino acid)s, regarding yield, reaction time and atom economy.The production of polypeptides using the ring opening polymerization of amino acid N-Carboxyahydride monomers results in limited polydispersity, little side product formation, high reproducibility, flexible architectures and precise functionalization of the polypeptide backbone.Polymers based on amino acid monomers have attracted a lot of attention in drug delivery. As the manufacturing of PAA or polyamides involves numerous challenges, many companies prefer to outsource their needs. There are several CDMOs for polyamino acids offering custom synthesis and manufacturing for GMP Polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.What are the polyamino acid based polymer manufacturing services offered by PMC Isochem?A contract development and manufacturing organization (CDMO), PMC Isochem provides amino acid based polymer diversity for drug delivery and innovative treatments. From R&D to GMP large-scale production, PMC Isochem offers polypeptide excipients and drug-polymer conjugates along with GMP polymers and copolymers based on various polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc.Polyamino acid based delivery is a major area of interest for advanced biomedicines because of its biocompatibility and biodegradability. The chemical & architectural versatility of polyamino acids & polypeptides is enormous. Polyamide acids are utilized in several therapeutic areas, including immunotherapy, oncology, gene therapy, inflammatory, neurodegenerative, infectious, diagnosis, skin care, etc. Synthetic GMP polyamino acids are being used in biomedical and drug delivery applications as they are structurally similar to naturally occurring proteins. Drug–polymer conjugates offer improved pharmacokinetic and properties with enhanced stability for targeted drug delivery. PMC Isochem is a CDMO for polyamino acids integrated in strategic monomers NCA (α-aminoacid N-CarboxyAnhydride) offeringStandard and customized GMP polyamino acidDevelopment and characterizationScale-up and clinical supplyCommercial manufacturingPMC Isochem has 40 years experience in large-scale GMP custom manufacturing of polyamino acids (PAA) from kilolab to full-scale production. It has 3 production sites in France and has manufacturing facilities audited by the US & EU regulatory agencies. PMC Isochem is a widely known CDMO for polyamino acids. It provides custom-made Polyamino acid (PAA) design for its clients, which is supported by integrated NCA supply and development for GMP polymers and copolymers based on different polyamino acids like Poly-L-Lysine, Poly-L-Glutamic acid, Polysarcosine, etc. PMC Isochem has a highly skilled and diversified R&D team with academic affiliations. It has fully equipped infrastructures and a network for accessing cutting-edge technologies for polyamino acid based delivery. PMC Isochem has a lean approach to provide cheaper, faster and better solutions, which allows its clients to save cost, time and risk. To help its customers grow their businesses, PMC Isochem has a flexible and creative business development team with IP portfolio and proprietary GMP polyamino acid (PAA) systems.

Impressions: 1723

NEWS #PharmaBuzz