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Desloratadine | CAS No: 100643-71-8 | GMP-certified suppliers
A medication that provides consistent relief from seasonal and perennial allergic rhinitis symptoms and reduces pruritus and hives associated with chronic idiopathic urticaria for reliable formulation needs.
Therapeutic categories
Primary indications
- For the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis
- Desloratidine is also used for the sympomatic treatment of pruritus and urticaria (hives) associated with chronic idiopathic urticaria
Product Snapshot
- Desloratadine is an oral and intranasal small‑molecule antihistamine available in multiple solid and liquid formulations
- It is used for symptomatic management of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria
- It is approved in the US, EU, and Canada, with both approved and investigational statuses noted for certain applications
Clinical Overview
Pharmacologically, desloratadine is characterized by high affinity for peripheral H1 receptors, blocking the actions of endogenous histamine released from mast cells during allergic responses. By preventing histamine‑induced activation of target cells, it reduces nasal, ocular, and dermal symptoms. Its lack of appreciable blood–brain barrier permeability contributes to a reduced sedative profile relative to first‑generation antihistamines.
The mechanism of action involves competitive antagonism at H1 receptors located in bronchial and gastrointestinal smooth muscle, vascular endothelium, and other peripheral tissues. This inhibition attenuates histamine‑mediated vasodilation, vascular permeability, and sensory nerve activation.
Desloratadine demonstrates long‑acting activity, supporting once‑daily dosing in clinical practice. Published data indicate rapid oral absorption and metabolism primarily via oxidative pathways, although detailed human pharmacokinetic parameters such as absolute bioavailability and specific metabolic isoforms are not consistently reported across sources. It is generally well tolerated, with common adverse effects including headache and fatigue. Post‑marketing experience has noted a potential for QT interval prolongation, warranting caution in patients with known risk factors or concomitant QT‑prolonging agents.
It is available globally in multiple branded and generic products for systemic antihistamine therapy, often coexisting in markets alongside loratadine as part of the same therapeutic class.
For API procurement, suppliers should ensure control of stereochemical identity, residual solvent levels, and impurity profiles consistent with pharmacopoeial standards. Verification of GMP compliance and validated analytical methods is essential to support regulatory submissions and formulation development.
Identification & chemistry
| Generic name | Desloratadine |
|---|---|
| Molecule type | Small molecule |
| CAS | 100643-71-8 |
| UNII | FVF865388R |
| DrugBank ID | DB00967 |
Pharmacology
| Summary | Desloratadine is a second‑generation histamine H1‑receptor antagonist that competitively blocks peripheral H1 receptors to reduce histamine‑mediated cellular activation. By limiting downstream inflammatory signaling triggered by histamine release, it mitigates key manifestations of allergic responses. Its limited penetration into the central nervous system contributes to minimal central H1 activity. |
|---|---|
| Mechanism of action | Like other H1-blockers, Desloratadine competes with free histamine for binding at H<sub>1</sub>-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine. |
| Pharmacodynamics | Desloratadine is a long-acting second-generation H<sub>1</sub>-receptor antagonist which has a selective and peripheral H1-antagonist action. Histamine is a chemical that causes many of the signs that are part of allergic reactions, such as the swelling of tissues. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergies. Desloratadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of cells by histamine. Unlike most other antihistamines, Desloratadine does not enter the brain from the blood and, therefore, does not cause drowsiness. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histamine H1 receptor | Humans | antagonist |
ADME / PK
| Absorption | Desloratadine administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean T<sub>max</sub> of approximately 3 hours, a mean steady-state C<sub>max</sub> of 4 ng/ml, and a mean steady-state AUC of 56.9 ng\*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption. |
|---|---|
| Half-life | Desloratadine has a mean plasma elimination half-life of approximately 27 hours. |
| Protein binding | Desloratadine is bound approximately 82 to 87% to plasma proteins, while its active metabolite, 3-hydroxydesloratadine, is bound approximately 85 to 89%. |
| Metabolism | Desloratadine is metabolized to the active metabolite 3-hydroxydesloratadine, which is subsequently glucuronidated. |
| Route of elimination | Approximately 87% of a <sup>14</sup>C-desloratadine dose was equally recovered in urine and feces as metabolic products. |
Formulation & handling
- Oral small‑molecule antihistamine with poor aqueous solubility, requiring solubility‑enhancing strategies for liquid and fast‑dissolving formulations.
- Food has minimal impact on absorption, so no special fed‑state considerations are typically required during formulation.
- Solid oral forms may require particle‑size control and wetting agents to ensure consistent dissolution performance.
Regulatory status
| Lifecycle | Patent protection for the API has largely lapsed, with expiries in the United States (2010 and 2020) and Canada (2018), indicating a mature lifecycle. Across the EU, Canada, and the US, the market is expected to function as a predominantly post‑patent environment. |
|---|
| Markets | EU, Canada, US |
|---|
Supply Chain
| Supply chain summary | Desloratadine’s supply landscape includes originator entities associated with the Schering/Schering‑Plough group, alongside multiple generic‑focused manufacturers that indicate a diversified API and finished‑dose supply base. Branded products are established in the US, EU, and Canada, with broad global availability. Key US and Canadian patents have expired, supporting the presence of existing and expanding generic competition across these markets. |
|---|
Safety
| Toxicity | Information regarding desloratadine overdose is limited, although somnolence has been reported. In case of overdose, symptomatic and supportive treatment, including removing the unabsorbed drug, is recommended; note, however, that desloratadine and its active metabolite 3-hydroxydesloratadine cannot be eliminated by hemodialysis. In animal studies, lethality was observed at or above doses of 250 mg/kg in rats and of 353 mg/kg in mice (oral LD<sub>50</sub>), doses that represent 120 and 290 times the human exposure based on the recommended daily oral dose. In monkey, no deaths occurred at doses up to 250 mg/kg, representing an exposure roughly 810 times that of the recommended dose in humans. |
|---|
- Overdose reports primarily note central nervous system effects such as somnolence
- Desloratadine and its active metabolite are not removed by hemodialysis, indicating limited dialyzability
- Oral acute toxicity in animals shows high LD50 thresholds: approximately 250 mg/kg in rats and 353 mg/kg in mice, with no lethality observed in monkeys up to 250 mg/kg
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Desloratadine is a type of Antihistamines
Antihistamines are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the treatment of allergies and allergic reactions. These compounds work by blocking the action of histamines, which are responsible for triggering allergic symptoms such as itching, sneezing, runny nose, and watery eyes.
Antihistamines can be classified into two main categories: first-generation and second-generation antihistamines. First-generation antihistamines, such as diphenhydramine and chlorpheniramine, have been in use for several decades. They are effective in relieving allergy symptoms but are associated with drowsiness and other side effects due to their ability to cross the blood-brain barrier.
On the other hand, second-generation antihistamines, including cetirizine, loratadine, and fexofenadine, offer similar allergy relief with fewer sedative effects. These newer antihistamines are preferred for their improved safety profiles, making them suitable for use during the day without causing significant drowsiness.
Antihistamines are available in various forms, including tablets, capsules, syrups, and topical creams. They are extensively used to manage conditions such as hay fever, hives, allergic rhinitis, and insect bites. Moreover, antihistamines may also be combined with decongestants or other medications to provide relief from nasal congestion and sinus symptoms.
As pharmaceutical APIs, antihistamines are produced through meticulous synthesis and manufacturing processes, adhering to strict quality standards. These APIs serve as the active components in various branded and generic pharmaceutical formulations, making them crucial in the pharmaceutical industry's production of allergy medications.
In conclusion, antihistamines are a significant subcategory of pharmaceutical APIs widely used for alleviating allergy symptoms. Their classification into first- and second-generation antihistamines offers options based on efficacy and sedative effects. By blocking histamines, antihistamines provide relief from common allergic reactions, making them essential in the development of effective allergy medications.
Desloratadine (Antihistamines), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Desloratadine API manufacturers & distributors
Compare qualified Desloratadine API suppliers worldwide. We currently have 19 companies offering Desloratadine API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Amsal Chem | Producer | India | India | CoA, ISO9001, USDMF, WC, WHO-GMP | 8 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, WC | 164 products |
| Divis Labs. | Producer | India | India | CoA, FDA, GMP, ISO9001, Other, WC | 47 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| Hetero Labs | Producer | India | Unknown | CEP, CoA, FDA, GMP | 90 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Mahalaxmi Chemi Pharm | Producer | India | India | CoA | 13 products |
| Morepen Laboratories Ltd. | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, WC | 22 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 201 products |
| PLIVA | Producer | Czech Republic | Croatia | CoA, GMP | 31 products |
| Rolabo Outsourcing | Producer | Spain | Spain | CEP, CoA, GMP | 11 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 219 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC | 37 products |
When sending a request, specify which Desloratadine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Desloratadine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Desloratadine API
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Technical
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Regulatory
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