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
This PharmaReel showcases ChemWerth, a full-service generic API company with over 40 years of experience, offering cGMP-quality APIs through 30+ manufacturing partners across the US, EU, India, and China, backed by 550+ global filings, and expertise in new product development, compliance, and logistics.
The
third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US
Food and Drug Administration (FDA). DMFs are used to provide confidential,
detailed information about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of human drug productsA
total of 323 Type II DMFs were submitted during this period, as opposed to 309
submissions in Q3 2024, marking an increase of 4.53 percent. This is the second
highest number since 2018. In Q1 2025, 339 Type II filings were
recorded.Across
all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to
394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II
DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3,
reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in
DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs,
marking a 20.18 percent increase over 109 filings during the corresponding
period last year.The
United States stood a distant third with 17 filings, compared to 13 in Q3 2024.
Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The
Netherlands filed four, up from three. Spain submitted only one DMF, as against
seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in
Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of
all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally
with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3
2024.India’s Hetero Group followed with nine DMFs,
maintaining the same number of filings as Q3 2024. Biophore India
Pharmaceuticals ranked third with six DMFs, doubling its count from three
last year.Other
notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan
Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi
Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu
Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate
monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription
anticoagulant used to reduce the risk of stroke and to treat deep vein
thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until
October 2026 in the United States, with no generic currently available.In
terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3
2025.Olaparib, sold by AstraZeneca under the brand name
Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1
(GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs
for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat
iron-deficiency anemia) and vismodegib (an oral therapy for
basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine
first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out
of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug
User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective
generic drugs to the public and reduce costs to the industry.Fee
rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY
2025 and FY 2026 User Fee Rates
Generic
drug fee category
Fees
rates for FY 2025
Fees
rates for FY 2026
Applications:
Abbreviated
New Drug Application (ANDA)
US$
3,21,920
US$
3,58,247
Drug
Master File (DMF)
US$
95,084
US$
1,02,584
Facilities:
Active Pharmaceutical Ingredient (API)—Domestic
US$
41,580
US$
43,549
API—Foreign
US$
56,580
US$
58,549
Finished Dosage Form (FDF)—Domestic
US$
2,31,952
US$
2,38,943
FDF—Foreign
US$
2,46,952
US$
2,53,943
Contract Manufacturing Organization (CMO)—Domestic
US$
55,668
US$
57,346
CMO—Foreign
US$
70,668
US$
72,346
GDUFA
Program:
Large
size operation generic drug applicant
US$
18,91,664
US$
19,18,377
Medium
size operation generic drug applicant
US$
7,56,666
US$
7,67,351
Small
business generic drug applicant
US$
1,89,166
US$
1,91,838
Our viewFor several years prior to
the pandemic, India had a lead in Type II DMF submissions. In recent years,
China has surpassed India in DMF filings. But Q3 2025 numbers indicate that
Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from
across the world, we feel this healthy competition between drugmakers from the
two countries is good for the global pharmaceutical industry.
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