Please Wait
Applying Filters...
menu
    • menu
    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    Virtual Booth

    Contact Supplier

    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Virtual Booth

    Contact Supplier

    pharmacompass-1-m-2026-01-12

    Virtual Booth

    An Enquiry

    LEBSA- Your strategic API source for niche molecules.

    Virtual Booth

    Contact Supplier

    Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

    Virtual Booth

    Contact Supplier

    pharmacompass-2-m-2025-11-03

    Virtual Booth

    An Enquiry

    Menu

    Elanco

    EVENTS

    • Webinars & Exhibitions

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow

    Digital content

    Create Content with PharmaCompass, ask us

    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    mic“Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

    This week, SpeakPharma interviews Marie-Armelle Floc’h, Chief of Quality and Regulatory Affairs at HTL Biotechnology, a global leader in the development and the manufacturing of pharmaceutical-grade biopolymers headquartered in Javené, Brittany (France). Since 1992, HTL has pioneered the production of hyaluronic acid (HA) through proprietary biofermentation, achieving unmatched purity and consistency for applications in ophthalmology, dermatology and rheumatology. Floc’h highlights how HTL Biotechnology’s compelling portfolio of pharmaceutical-grade biopolymers is built on uncompromising quality standards. These standards have enabled the company to supply biopolymers for over 30 years without a single batch recall, firmly establishing its reputation for reliability and excellence. She also discusses the inauguration of HTL Biotechnology’s new sterile hyaluronic acid production unit — a major milestone that reinforces the company’s leadership in biopolymer manufacturing and enables the development of innovative formulations combining hyaluronic acid with thermo-sensitive active ingredients. This new capability opens the door to advanced biomedical applications where safety, stability and efficacy must be preserved without compromising the integrity of delicate molecules and which requires the highest quality standards. What distinguishes HTL Biotechnology’s biopolymer platforms in the market today? HTL Biotechnology has built its reputation on delivering pharmaceutical‑grade biopolymers (hyaluronic acid, polynucleotides and recombinant collagen) with unmatched purity and consistency. Since its founding in 1992, the company has focused on premium quality positioning. With more than 30 years of experience, HTL Biotechnology guarantees pharmaceutical-grade biopolymers of exceptional purity and exemplary consistency to our clients. We have had no batch recalls in 30 years, a record that underlines the rigor and reliability embedded in our processes. This was made possible by our fully-integrated site in France, where R&D laboratories, GMP manufacturing, quality control, and regulatory expertise are brought together under one roof. Such integration allows us to support our clients seamlessly throughout their product development journey, from early innovation through to global commercialization.Also, the inauguration of our new sterile hyaluronic acid production unit expands the possibilities for our HA to be used in advanced formulations with thermo-sensitive active ingredients, while upholding the uncompromising quality that defines HTL Biotechnology.Our operations are guided by internationally recognized standards, including ISO 13485 certification, which ensures the quality and safety required by medical device manufacturers worldwide.In addition, our Halal certification provides our customers with a significant advantage in accessing and expanding into markets where these requirements are essential for commercialization.Beyond certifications, our commitment to supporting global growth is reflected in the Drug Master Files we maintain across five continents, enabling our clients to accelerate product registration and bring innovative therapies to markets across the world more efficiently. By combining craftsmanship with pharmaceutical rigor, supported by state-of-the-art equipment and advanced bio-production methods, we ensure that every batch produced not only meets the strictest standards, but also delivers the reliability and consistency needed across the entire healthcare ecosystem. HIGHLIGHTS// Biopolymers with unmatched purity/record of no batch recalls/integrated facility in France/operations guided by global standards/new sterile HA unit for advanced formulations  Navigating the complex and evolving regulatory frameworks across global markets can be challenging for healthcare companies. Can you tell us more about how HTL Biotechnology supports its partners in this area? Regulatory support is part of our core premium services offer. We provide pharmaceutical regulatory support to ensure products meet the necessary compliance standards, so our partners can focus on their growth. Our dedicated regulatory professionals bring global and regional expertise, with a team specifically supporting customers in Asia. We offer personalized assistance adapted to their products and to the compliance standards of the target market. This includes personalized case-management support for regulatory file submissions with the concerned health authorities to minimize risks of refusal or delay, with the aim of achieving approval quickly and smoothly.Our offer for regulatory support continues beyond approval. We continuously monitor updates to regulations and provide post-commercialization support to our partners to help them manage any necessary regulatory updates.HIGHLIGHTS// Regulatory support offered as premium service/global and regional expertise/personalized case management for faster approvals/continuous regulatory support  How does HTL Biotechnology integrate sustainability and corporate responsibility into its operations? Sustainability is embedded in HTL Biotechnology’s strategic vision and day-to-day operations. In 2024, the company renewed its commitment to environmental responsibility by reinforcing its corporate social responsibility (CSR) roadmap. Tangible progress was made across multiple fronts: a 27 percent reduction in greenhouse gas emissions per kilogram of HA produced between 2021 and 2024, and a 34 percent reduction in water consumption per kilogram of HA since 2020. In 2024, we renewed the ISO 14001:2015 certification for its environmental management system, reflecting rigorous audit protocols and continual improvement cycles. All employees have been trained in the ISO 14001-certified environmental management system, and 78 percent of critical suppliers have signed HTL Biotechnology’s Responsible Purchasing Charter.These results reflect HTL Biotechnology’s structured and proactive approach to reducing its environmental footprint while maintaining the highest standards of quality and compliance.HIGHLIGHTS// Sustainability embedded in strategic vision/strong CSR roadmap with measurable progress/reduction in greenhouse gas emissions/responsible sourcing 

    Impressions: 3001

    subscribeSubscribe

    https://www.pharmacompass.com/speak-pharma/over-500-million-syringes-of-our-hyaluronic-acid-have-been-safely-used-worldwide

    PharmaCompass
    04 Nov 2025
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaAn Illustrious Journey of More Than 4 DecadesAn Illustrious Journey of More Than 4 Decades

    An Illustrious Journey of More Than 4 Decades
    An Illustrious Journey of More Than 4 Decades

    reelAn Illustrious Journey of More Than 4 Decades

    This PharmaReel showcases Granules India, manufacturing generic & high-potent APIs, PFIs & FDFs, and complex MUPS, supported by high volume world-class facilities and approvals from US FDA, EDQM, PMDA and ANVISA, serving 300+ customers in over 80 countries.

    Impressions: 79

    read-more

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).  Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 297 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 245

    https://www.pharmacompass.com/radio-compass-blog/fda-opoe

    #PharmaFlow by PHARMACOMPASS
    22 Jan 2026
    Share Share

    NEWS #PharmaBuzz

    [Sponsored by another company]read-more
    read-more
    Elanco Gets USDA Nod For Befrena To Treat Canine Dermatitis
    Elanco Gets USDA Nod For Befrena To Treat Canine Dermatitis

    31 Dec 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/elanco-receives-usda-approval-for-befrena-tirnovetmab-a-new-anti-il31-monoclonal-antibody-injection-targeting-canine-allergic-and-atopic-dermatitis-302651357.html

    PR NEWSWIRE
    31 Dec 2025
    Share Share
    FDA Approves Elanco's Credelio Quattro for New World Screwworm
    FDA Approves Elanco's Credelio Quattro for New World Screwworm

    18 Dec 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/elancos-credelio-quattro-ca1-lotilaner-moxidectin-praziquantel-and-pyrantel-chewable-tablets-receives-first-fda-conditional-approval-for-treatment-of-new-world-screwworm-in-dogs-302645913.html

    PR NEWSWIRE
    18 Dec 2025
    Share Share
    Elanco's drug gets emergency nod to treat deadly Parasite in Cats
    Elanco's drug gets emergency nod to treat deadly Parasite in Cats

    21 Nov 2025

    // PRESS RELEASE

    https://investor.elanco.com/press-releases/press-releases-details/2025/Elancos-Credelio-CAT-lotilaner-Receives-First-FDA-Emergency-Use-Authorization-EUA-for-Treatment-of-New-World-Screwworm-NWS-in-Cats/default.aspx

    PRESS RELEASE
    21 Nov 2025
    Share Share
    Elanco Receives FDA Emergency Approval For Dog Drug
    Elanco Receives FDA Emergency Approval For Dog Drug

    24 Oct 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/elanco-gets-us-fda-emergency-nod-dog-drug-threat-flesh-eating-parasite-looms-2025-10-24/

    REUTERS
    24 Oct 2025
    Share Share
    Neurizon Enters into Global License with Elanco for NUZ-001
    Neurizon Enters into Global License with Elanco for NUZ-001

    02 Jul 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neurizon-enters-into-global-license-with-elanco-to-accelerate-commercialisation-of-nuz-001-302497328.html

    PR NEWSWIRE
    02 Jul 2025
    Share Share
    Credelio Quattro Provides Broadest Parasite Protection of Its Kind
    Credelio Quattro Provides Broadest Parasite Protection of Its Kind

    23 Jan 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/now-available-credelio-quattro-lotilaner-moxidectin-praziquantel-and-pyrantel-chewable-tablets-provides-broadesti-parasite-protection-of-its-kind-302357947.html

    PR NEWSWIRE
    23 Jan 2025
    Share Share
    Contact Elanco and get a quotation

    Elanco is a supplier offers 35 products (APIs, Excipients or Intermediates).

    Find a price of Closantel Sodium bulk with CEP offered by Elanco

    Find a price of Diclazuril bulk with DMF offered by Elanco

    Find a price of Tiamulin Fumarate bulk with CEP offered by Elanco

    Find a price of Tylosin Tartrate bulk with CEP offered by Elanco

    Find a price of Benoxaprofen bulk offered by Elanco

    Find a price of Cephalexin bulk offered by Elanco

    Find a price of Apramycin Sulfate bulk offered by Elanco

    Find a price of Avilamycin bulk offered by Elanco

    Find a price of Capromorelin bulk offered by Elanco

    Find a price of Carnidazole bulk offered by Elanco

    Find a price of Emodepside bulk offered by Elanco

    Find a price of Enrofloxacin bulk offered by Elanco

    Find a price of Estradiol bulk offered by Elanco

    Find a price of Febantel bulk offered by Elanco

    Find a price of Grapiprant bulk offered by Elanco

    Find a price of Imidacloprid bulk offered by Elanco

    Find a price of Lotilaner bulk offered by Elanco

    Find a price of Lubabegron fumarate bulk offered by Elanco

    Find a price of Monensin Sodium bulk offered by Elanco

    Find a price of Narasin bulk offered by Elanco

    Find a price of Nicarbazin bulk offered by Elanco

    Find a price of Pradofloxacin bulk offered by Elanco

    Find a price of Ractopamine Hydrochloride bulk offered by Elanco

    Find a price of Recombinant Human Growth Hormone bulk offered by Elanco

    Find a price of Robenacoxib bulk offered by Elanco

    Find a price of Sulfadimidine bulk offered by Elanco

    Find a price of Tanomastat bulk offered by Elanco

    Find a price of Tilmicosin bulk offered by Elanco

    Find a price of Tylosin bulk offered by Elanco

    Find a price of Tylosin Phosphate bulk offered by Elanco

    Find a price of PLASTIC CAPSULE bulk offered by Elanco

    Find a price of BAY 74-7583 bulk offered by Elanco

    Find a price of MANUFACTURING OPERATIONS bulk offered by Elanco

    Find a price of HYGROMYCIN bulk offered by Elanco

    Find a price of FENTHION bulk offered by Elanco

    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.