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Tretinoin | CAS No: 302-79-4 | GMP-certified suppliers
A medication that supports remission in acute promyelocytic leukemia and addresses acne and other pigmentation‑related dermatologic conditions for diverse clinical needs.
Therapeutic categories
Agents that produce hypertensionAlkenesAnti-Acne PreparationsAnti-Acne Preparations for Topical UseAntineoplastic AgentsAntineoplastic and Immunomodulating Agents
Generic name
Tretinoin
Molecule type
small molecule
CAS number
302-79-4
DrugBank ID
DB00755
Approval status
Approved drug, Investigational drug, Nutraceutical drug
ATC code
L01XF01
Primary indications
- Oral tretinoin is indicated for induction of remission in adults and pediatric patients one year of age and older with acute promyelocytic leukemia (APL), characterized by the presence of t(15
- Translocation or presence of PML/RARα gene expression and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated
- Topical tretinoin is also indicated alone or in combination with [benzoyl peroxide] or [clindamycin] for the treatment of acne vulgaris
Product Snapshot
- Tretinoin is a small-molecule retinoid available in oral capsules and multiple topical formulations including creams, gels, lotions, and solutions
- It is used for remission induction in acute promyelocytic leukemia and for topical management of acne and other pigmentary or photoaging skin conditions
- It is approved in the US and Canada, with products marketed under approved, investigational, and nutraceutical statuses
Clinical Overview
Tretinoin (CAS 302-79-4), or all‑trans‑retinoic acid, is an endogenous metabolite of vitamin A used in oncology and dermatology. Oral formulations are indicated for induction of remission in acute promyelocytic leukemia in patients with the t(15;17) translocation or PML‑RARα expression who are refractory to, relapsed from, or unable to receive anthracycline‑based therapy. Topical formulations are indicated for acne vulgaris, either alone or in fixed‑dose combinations with agents such as benzoyl peroxide or clindamycin. Additional dermatologic uses include melasma, hyperpigmentation, and photoaging.
Pharmacologically, tretinoin regulates epithelial growth and differentiation. In dermatologic use, it normalizes keratinocyte turnover, promotes desquamation, increases epidermal thickness, and supports collagen synthesis while reducing collagen degradation through inhibition of matrix metalloproteinases. These effects underlie its activity in comedonal acne and photodamaged skin. Concentrations between 0.001 percent and 0.1 percent have shown structural and clinical improvements in controlled studies.
In oncology, tretinoin promotes terminal differentiation of malignant promyelocytes. The PML‑RARα fusion protein generated by the t(15;17) translocation disrupts normal retinoid receptor signaling. Tretinoin binds retinoic acid receptors and retinoid X receptors and facilitates degradation or functional reversal of the fusion protein, enabling maturation of leukemic cells and recovery of normal hematopoiesis.
Absorption depends on the route of administration, with minimal systemic exposure after topical use. Tretinoin is metabolized primarily by cytochrome P450 enzymes and undergoes further conjugation. It has a short systemic half‑life and low circulating concentrations under physiological conditions.
Key safety considerations include retinoid dermatitis with topical use and the risk of differentiation syndrome, leukocytosis, and hepatic effects with systemic therapy. Photosensitivity may occur, and concurrent use of other irritants can increase local reactions.
For API procurement, suppliers should provide evidence of stereochemical integrity, control of oxidative impurities, and compliance with applicable pharmacopoeial specifications and retinoid handling requirements.
Pharmacologically, tretinoin regulates epithelial growth and differentiation. In dermatologic use, it normalizes keratinocyte turnover, promotes desquamation, increases epidermal thickness, and supports collagen synthesis while reducing collagen degradation through inhibition of matrix metalloproteinases. These effects underlie its activity in comedonal acne and photodamaged skin. Concentrations between 0.001 percent and 0.1 percent have shown structural and clinical improvements in controlled studies.
In oncology, tretinoin promotes terminal differentiation of malignant promyelocytes. The PML‑RARα fusion protein generated by the t(15;17) translocation disrupts normal retinoid receptor signaling. Tretinoin binds retinoic acid receptors and retinoid X receptors and facilitates degradation or functional reversal of the fusion protein, enabling maturation of leukemic cells and recovery of normal hematopoiesis.
Absorption depends on the route of administration, with minimal systemic exposure after topical use. Tretinoin is metabolized primarily by cytochrome P450 enzymes and undergoes further conjugation. It has a short systemic half‑life and low circulating concentrations under physiological conditions.
Key safety considerations include retinoid dermatitis with topical use and the risk of differentiation syndrome, leukocytosis, and hepatic effects with systemic therapy. Photosensitivity may occur, and concurrent use of other irritants can increase local reactions.
For API procurement, suppliers should provide evidence of stereochemical integrity, control of oxidative impurities, and compliance with applicable pharmacopoeial specifications and retinoid handling requirements.
Identification & chemistry
| Generic name | Tretinoin |
|---|---|
| Molecule type | Small molecule |
| CAS | 302-79-4 |
| UNII | 5688UTC01R |
| DrugBank ID | DB00755 |
Pharmacology
| Summary | Tretinoin is a retinoic acid derivative that modulates gene transcription by activating RAR and RXR nuclear receptors, influencing epidermal differentiation, keratinocyte turnover, and collagen-related pathways. In skin disorders, it normalizes follicular keratinization, enhances cell turnover, and reduces inflammatory and pigmentary activity. In acute promyelocytic leukemia, tretinoin targets the PML‑RARα fusion protein to restore myeloid differentiation and promote degradation of the oncogenic complex. |
|---|---|
| Mechanism of action | The exact mechanism of action of tretinoin in skin conditions and acute promyelocytic leukemia (APL) has not been fully elucidated; however, several proposed mechanisms exist. Tretinoin is believed to exert its pharmacological actions by binding to and activating two types of nuclear receptors - retinoic acid receptors (RARs) alpha, beta, and gamma and retinoid X receptors (RXRs). In the human skin, RARs (especially RAR-alpha) form heterodimers with RXR to act as inducible transcription regulators of genes involved in cell differentiation by binding to retinoic acid response elements.Tretinoin binds to RXRs to promote epidermal proliferation. It also blocks the actions of inflammatory mediators, enhancing procollagen production and collagen type I and III formations.Some animal and human studies suggest that tretinoin induces the expression of transforming growth factor beta (TGF-β), which stimulates the transcription of several types of collagen messenger RNA. Collagen formation curtails further solar UV-induced skin damage and aging processes. Acne is associated with abnormal follicular formation from excessive keratinization of epithelial cells. Tretinoin promotes cornified cell detachment and enhances keratinocyte shedding. It also stimulates mitotic activity and loosely-adherent corneocyte turnover to expel comedo contents, reducing microcomedo precursor lesions of acne vulgaris.Tretinoin may reduce epidermal melanin and pigmentation by increasing keratinocyte turnover and reducing tyrosinase activity. RAR-alpha and -beta have also been implicated in APL.APL is characterized by a t(15;17) chromosomal translocation, which fuses the promyelocytic myeloid leukemia (PML) gene with the RAR-alpha gene.The resulting PML-RAR-alpha fusion protein plays a role in the pathogenesis of APL by aberrating promyelocyte differentiation. The PML-RAR-alpha fusion protein is found to be predominant in leukemic cells, exerting a dominant negative effect on RAR, RXR and PML function.Tretinoin induces terminal differentiation in hemopoietic precursor cell lines and APL cells.Tretinoin is believed to promote caspase-mediated cleavage and proteasome-dependent degradation to cause apoptosis and degradation of the PML-RAR-alpha fusion protein.It may also convert the fusion protein from a transcription repressor to an activator. |
| Pharmacodynamics | Tretinoin is a vitamin A derivative that promotes cell production, proliferation, and differentiation. When used topically, tretinoin regulates epidermal cell turnover and collagen production. It also prevents collagen loss, reduces inflammation, and blocks the induction of matrix metalloproteinase (MMP), which are enzymes that disrupt collagen and elastic fibres.In short-term and long-term studies, topical application of tretinoin at doses ranging from 0.001% to 0.1% was associated with improvements in clinical signs of photoaging and fine wrinkles, increased epidermal thickness, compaction of the stratum corneum, and decreased melanin content.It also improved melanocyte differentiation and distribution, promotion of epidermal hyperplasia, and angiogenesis. Tretinoin exhibits antineoplastic activities when given orally.Tretinoin was shown to induce differentiation in tumour cells.It induced cytodifferentiation and decreased acute promyelocytic leukemia (APL) cell proliferation in culture and _in vivo_. In patients with APL, tretinoin promoted the initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Retinoic acid receptor alpha | Humans | agonist |
| Retinoic acid receptor beta | Humans | agonist |
| Retinoic acid receptor gamma | Humans | agonist |
ADME / PK
| Absorption | Tretinoin applied topically is expected to remain on the stratum corneum and undergo minimal systemic absorption.In one study, the topical application of radiolabelled tretinoin for 28 days was associated with a total percutaneous absorption of 2%. The extent of absorption was examined after a once-daily application of 1.9 g of the combination product with [benzoyl peroxide] for 14 days. On Day 14, at steady-state, the mean C<sub>max</sub> was 0.15-0.19 ng/mL for tretinoin, 0.27-0.34 ng/mL for the metabolite 4-keto 13-cis retinoic acid, and 0.13-0.28 ng/mL for 13-cis retinoic acid, respectively. The C<sub>max</sub> varied across different age groups (children, adolescents, and adults). The corresponding ranges for the mean AUC<sub>0-24</sub> were 0.63-2.06, 2.39-2.89, and 0.96-1.99 ng\*h/mL. Following oral administration, the absolute bioavailability of tretinoin was approximately 50%.While the effect of food on tretinoin is unclear, food increases the oral absorption of retinoids, as a class.When the oral dose of 22.5 mg/m<sup>2</sup> tretinoin was administered twice daily, the mean ± SD C<sub>max</sub> was 394 ± 89 ng/mL after the first dose and 138 ± 139 ng/mL after one week of continuous treatment. The area under the curve (AUC) was 537 ± 191 ng·h/mL after the first dose and 249 ± 185 ng·h/mL after one week of continuous treatment. The T<sub>max</sub> was between one and two hours. |
|---|---|
| Half-life | The terminal elimination half-life of tretinoin following initial dosing is 0.5 to 2 hours in patients with APL. |
| Protein binding | Protein binding of tretinoin is greater than 95%, predominately to albumin.Plasma protein binding remains constant over the 10 to 500 ng/mL concentration range. |
| Metabolism | Tretinoin is rapidly metabolized to form various oxidized and conjugated metabolites. It forms several metabolites stereoisomerization derivatives (9-_cis_-retinoic acid or [alitretinoin] and 13-_cis_-retinoic acid or [isotretinoin]), oxidation derivatives (4-hydroxy-retinoic acid, 4-oxo-retinoic acid, 18-hydroxy-retinoic acid, 5,6-epoxy-retinoic acid, 3,4-didehydro-retinoic acid and retinotaurine), stereoisomerization and oxidation derivatives (13-_cis_-4-oxo-retinoic acid), glucuronidation derivatives (retinoyl beta-glucuronide, 13-_cis_-retinoyl beta-glucuronide, 4-oxo-retinoyl beta-glucuronide, 5,6-epoxyretinoyl beta-glucuronide and 13-_cis_-4-oxo-retinoyl beta-glucuronide), nonpolar metabolites of retinoic acid, and retinoic acid esters. Tretinoin is metabolized by several CYP enzymes, including CYP3A4, CYP2C8, and CYP2E. It also undergoes glucuronidation by UGT2B7. The metabolites 4-oxo retinoic acid and 4-oxo _trans_ retinoic acid glucuronide have one-third of the pharmacological activity of the parent compound.When the plasma concentrations decreased to one-third of their day-one concentrations after one week of continuous therapy, tretinoin induced its own metabolism. |
| Route of elimination | Tretinoin metabolites are excreted in bile and urine.Following administration of radiolabeled tretinoin at doses of 2.75 mg and 50 mg - which are 0.53 to 9.6 times the approved recommended dosage based on 1.7 m<sup>2</sup>, respectively - approximately 63% of the radioactivity was recovered in the urine within 72 hours, and 31% appeared in the feces within six days. |
| Volume of distribution | Tretinoin is rapidly and extensively distributed to tissues following oral administration but does not cross the blood-brain barrier. The apparent volume of distribution (V<sub>d</sub>) of intravenous tretinoin is dose-dependent and significantly greater at low doses. The V<sub>d</sub> was 0.52 ± 0.12 L/kg after 0.0125 mg/kg and 0.21 ± 0.05 L/kg after 0.25 mg/kg. |
| Clearance | No information is available. |
Formulation & handling
- Tretinoin is a highly lipophilic, poorly water‑soluble small molecule requiring non‑aqueous or emulsified systems for topical delivery and lipid‑based vehicles for oral capsules.
- The API is light‑ and oxygen‑sensitive, necessitating protected processing, antioxidant use, and opaque or amber packaging to maintain stability.
- Oral formulations may show food‑related increases in retinoid bioavailability, so capsule development should consider fed‑state absorption variability.
Regulatory status
| Lifecycle | Most U.S. patent protection for the API ended in 2022, indicating that the product is now in a post‑exclusivity phase. With commercialization limited to the US and Canada, the market position reflects a mature lifecycle with expected generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Tretinoin’s supply landscape includes an originator presence associated with Hoffmann-La Roche, alongside a large number of generic manufacturers that now dominate production. The product is widely distributed in North American markets, with branded and compounded formulations mainly recorded in the United States and Canada. All listed U.S. patents have expired, supporting the extensive generic competition currently reflected in the manufacturer and packager base. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 2000 mg/kg. The dermal LD<sub>50</sub> in rabbits is >2500 mg/kg. Reversible signs of hypervitaminosis A, such as headache, nausea, vomiting, and mucocutaneous symptoms, are expected to appear in tretinoin overdose. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia: these symptoms have quickly resolved without apparent residual effects. here is no specific treatment in the case of an overdose and it is advised to treat patients experiencing tretinoin overdose in a special hematological unit. |
|---|
High Level Warnings:
- Oral LD50 in rats is 2000 mg/kg, and dermal LD50 in rabbits exceeds 2500 mg/kg, indicating low acute toxicity but warranting standard industrial exposure controls
- Overexposure may produce reversible hypervitaminosis A–type effects (e
- G
Tretinoin is a type of Retinoids
Retinoids are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in dermatology and skincare products. Derived from vitamin A, retinoids play a crucial role in promoting skin health and treating various skin conditions. They are popular due to their proven effectiveness in combating acne, reducing wrinkles, and improving overall skin texture.
Retinoids work by binding to specific receptors in the skin cells, influencing gene expression and cellular processes. This action helps regulate the growth and differentiation of skin cells, promoting the turnover of old cells and the production of new, healthier cells. As a result, retinoids can unclog pores, reduce sebum production, and prevent the formation of acne lesions.
Furthermore, retinoids stimulate collagen production, which enhances skin elasticity and reduces the appearance of fine lines and wrinkles. They also possess antioxidant properties, protecting the skin from damage caused by environmental factors such as UV radiation.
Common retinoids used in skincare formulations include retinol, retinaldehyde, and tretinoin (also known as all-trans retinoic acid). These compounds vary in their potency and stability, with tretinoin being the most potent and retinol requiring conversion within the skin to become active.
However, it is important to note that retinoids may cause skin irritation, redness, and dryness, especially during the initial stages of usage. Gradual introduction and proper skincare routines can help minimize these side effects.
In summary, retinoids are a highly sought-after subcategory of pharmaceutical APIs for their significant benefits in skincare. They offer a promising solution for those seeking to improve their skin's health, combat acne, and reduce signs of aging.
Tretinoin (Retinoids), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Tretinoin API manufacturers & distributors
Compare qualified Tretinoin API suppliers worldwide. We currently have 7 companies offering Tretinoin 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Biophore India | Producer | India | India | CoA, USDMF | 46 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Senova Technology Co., Lt... | Producer | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 157 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 757 products |
When sending a request, specify which Tretinoin 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 Tretinoin 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 Tretinoin API
Sourcing
What matters most when sourcing GMP-grade Tretinoin?
Key considerations include confirming GMP compliance and ensuring the manufacturer meets U.S. and Canadian regulatory expectations. It is also important to source from qualified producers with established quality systems, given the broad generic manufacturing base. Reviewing regulatory documentation and supply reliability helps manage variability in a market with many competing suppliers.
Which documents are typically required when sourcing Tretinoin API?
Request the core API documentation set: CoA (8 companies), MSDS (7 companies), GMP (6 companies), ISO9001 (6 companies), USDMF (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Tretinoin API?
Known or reported manufacturers for Tretinoin: Caesar & Loretz GmbH (CAELO), Senova Technology Co., Ltd., Xi'an Tian Guangyuan Biotech Co.,Ltd, Global Pharma Tek, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Tretinoin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Tretinoin manufacturers?
Audit reports may be requested for Tretinoin: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Tretinoin API on Pharmaoffer?
Reported supplier count for Tretinoin: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Tretinoin API?
Production countries reported for Tretinoin: China (3 producers), India (2 producers), Singapore (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Tretinoin usually hold?
Common certifications for Tretinoin suppliers: CoA (8 companies), MSDS (7 companies), GMP (6 companies), ISO9001 (6 companies), USDMF (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Tretinoin (CAS 302-79-4) used for?
Tretinoin is used topically to treat acne vulgaris and dermatologic conditions such as melasma, hyperpigmentation, and photoaging by normalizing keratinocyte turnover and promoting epidermal repair. Oral Tretinoin is used to induce remission in acute promyelocytic leukemia characterized by the t(15;17) translocation or PML‑RARα expression.
Which therapeutic class does Tretinoin fall into?
Tretinoin belongs to the following therapeutic categories: Agents that produce hypertension, Alkenes, Anti-Acne Preparations, Anti-Acne Preparations for Topical Use, Antineoplastic Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Tretinoin mainly prescribed for?
The primary indications for Tretinoin: Oral Tretinoin is indicated for induction of remission in adults and pediatric patients one year of age and older with acute promyelocytic leukemia (APL), characterized by the presence of t(15, Translocation or presence of PML/RARα gene expression and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated, Topical Tretinoin is also indicated alone or in combination with [benzoyl peroxide] or [clindamycin] for the treatment of acne vulgaris. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Tretinoin work?
The exact mechanism of action of Tretinoin in skin conditions and acute promyelocytic leukemia (APL) has not been fully elucidated; however, several proposed mechanisms exist. Tretinoin is believed to exert its pharmacological actions by binding to and activating two types of nuclear receptors - retinoic acid receptors (RARs) alpha, beta, and gamma and retinoid X receptors (RXRs). In the human skin, RARs (especially RAR-alpha) form heterodimers with RXR to act as inducible transcription regulators of genes involved in cell differentiation by binding to retinoic acid response elements.Tretinoin binds to RXRs to promote epidermal proliferation. It also blocks the actions of inflammatory mediators, enhancing procollagen production and collagen type I and III formations.Some animal and human studies suggest that Tretinoin induces the expression of transforming growth factor beta (TGF-β), which stimulates the transcription of several types of collagen messenger RNA. Collagen formation curtails further solar UV-induced skin damage and aging processes.
Acne is associated with abnormal follicular formation from excessive keratinization of epithelial cells. Tretinoin promotes cornified cell detachment and enhances keratinocyte shedding. It also stimulates mitotic activity and loosely-adherent corneocyte turnover to expel comedo contents, reducing microcomedo precursor lesions of acne vulgaris.Tretinoin may reduce epidermal melanin and pigmentation by increasing keratinocyte turnover and reducing tyrosinase activity.
RAR-alpha and -beta have also been implicated in APL.APL is characterized by a t(15;17) chromosomal translocation, which fuses the promyelocytic myeloid leukemia (PML) gene with the RAR-alpha gene.The resulting PML-RAR-alpha fusion protein plays a role in the pathogenesis of APL by aberrating promyelocyte differentiation. The PML-RAR-alpha fusion protein is found to be predominant in leukemic cells, exerting a dominant negative effect on RAR, RXR and PML function.Tretinoin induces terminal differentiation in hemopoietic precursor cell lines and APL cells.Tretinoin is believed to promote caspase-mediated cleavage and proteasome-dependent degradation to cause apoptosis and degradation of the PML-RAR-alpha fusion protein.It may also convert the fusion protein from a transcription repressor to an activator.
What should someone know about the safety or toxicity profile of Tretinoin?
Tretinoin has low acute toxicity, with high oral and dermal LD50 values in animal studies, but standard industrial exposure controls are still required. Topical use commonly causes retinoid dermatitis and photosensitivity, especially when combined with other irritants. Systemic therapy can lead to differentiation syndrome, leukocytosis, and hepatic effects. Excess exposure may produce reversible hypervitaminosis A–type effects.
What are important formulation and handling considerations for Tretinoin as an API?
Important considerations include protecting the API from light and oxygen during manufacturing and storage, using antioxidants when appropriate, and selecting opaque or amber packaging to preserve stability. Because Tretinoin is highly lipophilic and poorly water‑soluble, topical products generally require non‑aqueous or emulsified systems, while oral products use lipid‑based vehicles. Formulators should account for potential food‑related increases in retinoid absorption when developing oral capsules.
Is Tretinoin a small molecule?
Tretinoin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Tretinoin?
Yes. Oral Tretinoin is light‑ and oxygen‑sensitive, so manufacturing and storage require protection from light, limited oxygen exposure, and use of antioxidants and opaque or amber containers. Its high lipophilicity and poor water solubility require lipid‑based capsule systems to maintain chemical stability and consistent delivery. Fed‑state increases in retinoid absorption mean that food‑related variability should be considered during formulation to limit exposure fluctuations.
Regulatory
Where is Tretinoin approved or in use globally?
Tretinoin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Tretinoin right now?
Tretinoin is an established, off‑patent active ingredient and is widely available in generic formulations. In the United States and Canada, it is regulated as a prescription drug, with requirements focused on quality, safety, and adherence to applicable drug product standards. No current market‑exclusive patents are associated with the API itself.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Tretinoin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Tretinoin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Tretinoin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Tretinoin: 860 verified transactions across 304 suppliers and 232 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Tretinoin?
Market report availability for Tretinoin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
