Several Foreign Specialties Reinforce French Pharmaceutical Supply Chain Amidst Ongoing Shortages

The French National Agency for the Safety of Medicines and Health Products (ANSM) has reported a series of significant disruptions and updated availability data for several pharmaceutical specialties marketed in France. These updates, which occurred between April 9th and April 14th, 2026, pertain to medications distributed through both community pharmacies and hospital channels, highlighting persistent challenges in ensuring consistent access to essential treatments for patients across the country. The situation underscores a broader European trend of pharmaceutical supply chain vulnerabilities, necessitating increased reliance on international sourcing and agile distribution strategies.

Understanding the Scope of the Disruptions

The ANSM’s weekly reports on drug availability are critical for healthcare professionals, pharmacists, and patients, providing timely information on potential shortages. These disruptions can stem from a multitude of factors, including manufacturing delays, raw material scarcity, increased global demand, regulatory hurdles, and geopolitical events. The agency’s proactive communication aims to mitigate the impact of these shortages by allowing for the implementation of contingency plans, such as the temporary use of alternative medications or the sourcing of supplies from other European markets.

Specific Medications Affected and Projected Timelines

The recent ANSM updates detail several key medications experiencing availability issues:

BETNEVAL 0.1% Cream: Facing Tension Until Mid-May 2026

BETNEVAL 0.1% cream, a topical corticosteroid containing betamethasone valerate, has been identified as being in a state of "tension." This indicates that while the medication is still available, its supply is significantly constrained, potentially leading to delays in dispensing and challenges for patients requiring regular treatment. The ANSM projects this shortage to persist until mid-May 2026, a timeframe that necessitates careful inventory management by pharmacies and consideration of alternative treatments by prescribers where clinically appropriate. Betamethasone valerate is commonly prescribed for inflammatory skin conditions such as eczema, psoriasis, and dermatitis, making its availability crucial for managing chronic and acute dermatological issues. The extended period of tension suggests a complex underlying issue affecting the production or distribution of this widely used dermatological agent.

CLOMIPRAMINE VIATRIS 25 mg: Dosage Under Strain Until July 2026

The 25 mg dosage of CLOMIPRAMINE VIATRIS, an oral medication containing clomipramine, is also experiencing a supply shortage. Clomipramine is a tricyclic antidepressant (TCA) primarily used to treat obsessive-compulsive disorder (OCD), panic disorder, and major depressive disorder. The 25 mg dosage is often a starting point for treatment or used for specific patient needs, making its scarcity particularly concerning. The ANSM anticipates that this specific formulation will remain under strain until July 2026. This extended shortage could significantly impact patients managing mental health conditions, potentially leading to treatment interruptions, exacerbation of symptoms, and increased reliance on alternative antidepressant classes, which may not be as effective for all individuals. The prolonged nature of this shortage points to potential manufacturing capacity issues or significant delays in the supply chain for this specific clomipramine product.

KETOPROFENE PHARMY II: Third Postponement of Availability

KETOPROFENE PHARMY II, specifically the 100 mg/2 mL intramuscular injectable solution containing ketoprofen, has faced its third postponement in its return to availability. Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) used to manage pain and inflammation associated with conditions like arthritis and musculoskeletal injuries. The repeated delays in the availability of this injectable form suggest a persistent and significant problem with its production or regulatory approval process. For patients requiring rapid pain relief or those for whom oral administration is not suitable, the lack of this injectable option presents a considerable challenge. The repeated postponements raise questions about the root cause of the manufacturing or supply chain issues affecting this specific product and its active ingredient.

Venlafaxine LP 37.5 mg and 75 mg: Continued Reliance on European Markets

Specialties of venlafaxine LP (long-acting) in 37.5 mg and 75 mg capsules, including the originator product EFFEXOR, continue to be subject to supply disruptions. Venlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) widely prescribed for depression, anxiety disorders, and panic disorder. The ongoing shortages have necessitated a continued strategy of sourcing supplies from other European markets to ensure patient access. This reliance on parallel imports or inter-country transfers highlights the interconnectedness of the European pharmaceutical market and the need for robust cross-border regulatory cooperation during times of scarcity. While this strategy provides a vital lifeline for patients, it also introduces logistical complexities and potential variations in packaging or patient information. The sustained nature of these venlafaxine shortages suggests systemic issues affecting its production on a broader scale, impacting multiple European countries.

XARELTO 1 mg/mL in 100 mL Bottles: Tension Until End of June 2026

XARELTO 1 mg/mL granules for oral suspension in 100 mL bottles, containing rivaroxaban, is experiencing a period of tension expected to last until the end of June 2026. Rivaroxaban is a direct oral anticoagulant (DOAC) used to prevent and treat blood clots, commonly prescribed for conditions such as atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). The availability of this specific formulation, particularly the larger 100 mL bottle size, is important for patients requiring long-term anticoagulation therapy. The extended tension until mid-2026 suggests a significant demand-supply imbalance or manufacturing challenges for this critical medication. Ensuring consistent access to anticoagulants is paramount to preventing serious cardiovascular events and complications.

Medications Returning to Availability

Amidst the ongoing disruptions, the ANSM has also confirmed the return to availability of several other pharmaceutical specialties, offering a degree of relief for healthcare providers and patients. These include:

• AMISULPRIDE MYLAN 200 mg film-coated tablets: This medication, containing amisulpride, an antipsychotic used to treat schizophrenia and other psychotic disorders, is now more readily available.
• AZITHROMYCINE TEVA 150 mg/5 mL oral suspension: Azithromycin is a macrolide antibiotic commonly used to treat a variety of bacterial infections, particularly respiratory and skin infections. The renewed availability of this pediatric suspension is crucial for treating younger patients.
• AZITHROMYCINE TEVA 500 mg film-coated tablets: The adult formulation of Azithromycin TEVA has also been confirmed as returning to availability, bolstering the supply of this essential antibiotic.
• CARVEDILOL MYLAN 25 mg film-coated tablets: Carvedilol is a beta-blocker and alpha-blocker used to treat high blood pressure and heart failure. Its return to availability is vital for patients managing these chronic cardiovascular conditions.
• CLARITYNE 10 mg tablets: Clarityne, containing the active ingredient loratadine, is a widely used antihistamine for treating allergy symptoms. Its re-availability offers relief to seasonal allergy sufferers.
• DICLOFENAC TEVA 100 mg prolonged-release capsules: Diclofenac is another NSAID used for pain and inflammation. The prolonged-release formulation is often prescribed for chronic pain conditions.
• ETORICOXIB TEVA 90 mg film-coated tablets: Etoricoxib is a selective COX-2 inhibitor NSAID used for pain and inflammation associated with conditions like osteoarthritis and rheumatoid arthritis.
• FLUOXETINE TEVA 20 mg capsules: Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), is a common antidepressant used for depression, OCD, and bulimia nervosa.
• IMODIUMDUO 2 mg/125 mg film-coated tablets: This medication combines loperamide and simethicone for the treatment of symptomatic diarrhea with abdominal discomfort, bloating, and cramps.
• KEDROLAC 10 mg/mL solution for injection: Kedrolac, containing ketorolac tromethamine, is a potent NSAID used for short-term management of moderate to severe pain.
• KESTIN 10 mg tablets: Kestin, containing ebastine, is an antihistamine used to relieve symptoms of allergic rhinitis and urticaria.
• LABETALOL MYLAN 100 mg film-coated tablets: Labetalol is another medication used for hypertension, particularly during pregnancy.
• LEVOTHYROXINE SODIUM TEVA 100 micrograms tablets: Levothyroxine is a synthetic thyroid hormone used to treat hypothyroidism. Consistent availability of thyroid hormone replacement therapy is critical for patients’ metabolic health.
• METRONIDAZOLE MYLAN 500 mg vaginal gel: Metronidazole is an antibiotic and antiprotozoal medication used to treat various infections, including bacterial vaginosis.
• MYCOHydralin 500 mg/5 mL oral suspension: This medication contains nystatin, an antifungal agent used to treat yeast infections of the mouth and digestive tract.
• NORMAFLOR 100 mg/5 mL oral suspension: Normaflor, containing Saccharomyces boulardii, is a probiotic used to treat and prevent diarrhea.
• PARACETAMOL TEVA 1000 mg film-coated tablets: Paracetamol (acetaminophen) is a widely used analgesic and antipyretic.
• PROPRANOLOL MYLAN 40 mg film-coated tablets: Propranolol is a beta-blocker used for various conditions, including high blood pressure, angina, and migraine prevention.
• RIOCIGUAT TEVA 2.5 mg film-coated tablets: Riociguat is a medication used to treat pulmonary hypertension.
• SERETIDE 50/250 micrograms/dose Diskus: Seretide is a combination inhaler containing salmeterol and fluticasone propionate, used for the management of asthma and COPD.
• SERETIDE 50/500 micrograms/dose Diskus: The higher dose of Seretide Diskus is also returning to availability.
• SIMVASTATINE TEVA 20 mg film-coated tablets: Simvastatin is a statin medication used to lower cholesterol levels.
• SINCEF 125 mg/5 mL oral suspension: Sincef, containing cefixime, is a cephalosporin antibiotic used to treat bacterial infections.
• SUBSTIFIBRE 3.5 g powder for oral suspension: Substifibre is a fiber supplement used to treat constipation.
• TERBINAFINE TEVA 250 mg film-coated tablets: Terbinafine is an antifungal medication used to treat fungal infections of the skin and nails.
• THYROXINE TEVA 75 micrograms tablets: Another dosage of Levothyroxine Teva returning to availability.
• TRETINOIN VIATRIS 0.05% cream: Tretinoin is a retinoid used to treat acne and certain signs of aging.
• VARFARNIL 5 mg film-coated tablets: This medication, containing verapamil, is a calcium channel blocker used to treat high blood pressure and certain heart conditions.
• VIBRAMYCINE 100 mg film-coated tablets: Vibramycin, containing doxycycline, is a broad-spectrum antibiotic used to treat a variety of infections.
• XEROFEN 250 mg/5 mL oral suspension: Xerofen, containing amoxicillin, is a penicillin-type antibiotic.
• ZALDIAR 37.5 mg/325 mg film-coated tablets: Zaldiar is a combination pain reliever containing tramadol and paracetamol.

The Broader Context: European Pharmaceutical Supply Chain Resilience

The recurring pharmaceutical shortages in France, and indeed across Europe, highlight systemic vulnerabilities within the global pharmaceutical supply chain. Factors contributing to these ongoing challenges include:

• Concentration of Manufacturing: A significant portion of active pharmaceutical ingredients (APIs) are manufactured in a limited number of countries, primarily in Asia. This concentration creates dependencies and increases the risk of disruptions due to geopolitical events, natural disasters, or localized production issues.
• Economic Pressures: The pharmaceutical industry faces constant pressure to reduce costs. This can lead to the closure of smaller manufacturing plants in Europe and a reliance on lower-cost production facilities overseas, potentially compromising supply chain resilience.
• Complex Regulatory Frameworks: While essential for ensuring drug safety and efficacy, the rigorous and often divergent regulatory requirements across different countries can add complexity and time to the approval and distribution of medications, especially during urgent supply situations.
• Increased Demand: An aging population, the rise of chronic diseases, and advancements in medical treatments have led to a sustained increase in global demand for pharmaceuticals.

ANSM’s Role and Strategies

The ANSM plays a crucial role in monitoring drug availability and implementing strategies to mitigate the impact of shortages. These strategies include:

• Information Dissemination: Providing real-time updates on drug availability to healthcare professionals.
• Facilitating Parallel Imports: Allowing the import of medicines from other European countries where they are available, ensuring continuity of care.
• Promoting Generic Use: Encouraging the use of generic alternatives when available and clinically appropriate.
• Collaborating with Manufacturers: Working closely with pharmaceutical companies to understand the root causes of shortages and to expedite the resolution of production and supply chain issues.
• International Cooperation: Engaging with other European medicines agencies to share information and coordinate responses to cross-border supply chain challenges.

Implications for Patients and Healthcare Providers

The ongoing pharmaceutical shortages have significant implications:

• Patient Impact: Patients may experience treatment interruptions, leading to potential health deterioration, increased anxiety, and a loss of confidence in the healthcare system. They may also face the burden of switching to alternative medications, which could be less effective or have different side effect profiles.
• Healthcare Provider Burden: Doctors, pharmacists, and nurses spend considerable time managing shortages, seeking alternative treatments, and communicating with patients. This diverts resources and attention from direct patient care.
• Increased Costs: While the ANSM facilitates parallel imports, these can sometimes be more expensive than locally sourced medications, potentially impacting healthcare system budgets.

The situation underscores the urgent need for a more robust and resilient European pharmaceutical supply chain. This requires a multi-faceted approach involving increased domestic manufacturing capacity for essential medicines, diversification of sourcing for APIs, enhanced regulatory harmonization, and greater transparency throughout the supply chain. The ANSM’s continued vigilance and proactive communication are vital in navigating these challenging times, but a broader strategic vision is necessary to ensure long-term pharmaceutical security for French citizens.