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Azelaic Acid (Azelex)

Trade Name : AZELEX

Almirall, LLC

CREAM

Strength 0.2 g/g

AZELAIC ACID Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azelaic Acid (Azelex) which is also known as AZELEX and Manufactured by Almirall, LLC. It is available in strength of 0.2 g/g per ml. Read more

Azelaic Acid (Azelex) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • n For Dermatologic Use Only Not for Ophthalmic Usen
  • AZELEX
  • Structural Formula: HOOC-(CH)-COOH
  • Chemical Name: 1,7-heptanedicarboxylic acid
  • Empirical Formula: CHOn
  • Molecular Weight: 188.22
  • The exact mechanism of action of azelaic acid is not known. The following data are available, but their clinical significance is unknown. Azelaic acid has been shown to possess antimicrobial activity against and The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.
  • A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its clinical activity. Electron microscopic and immunohistochemical evaluation of skin biopsies from human subjects treated with n cream demonstrated a reduction in the thickness of the stratum corneum, a reduction in number and size of keratohyalin granules, and a reduction in the amount and distribution of filaggrin (a protein component of keratohyalin) in epidermal layers. This is suggestive of the ability to decrease microcomedo formation.
  • Following a single application of n cream to human skin , azelaic acid penetrates into the stratum corneum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application. Approximately 4% of the topically applied azelaic acid is systemically absorbed. Azelaic acid is mainly excreted unchanged in the urine but undergoes some u03b2-oxidation to shorter chain dicarboxylic acids. The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics.
  • Azelaic acid is a dietary constituent (whole grain cereals and animal products), and can be formed endogenously from longer-chain dicarboxylic acids, metabolism of oleic acid, and u03c8-oxidation of monocarboxylic acids. Endogenous plasma concentration (20 to 80 ng/mL) and daily urinary excretion (4 to 28 mg) of azelaic acid are highly dependent on dietary intake. After topical treatment with n cream in humans, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels.
  • AZELEX
  • u00ae
  • AZELEX
  • u00ae
  • AZELEX
  • There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.
  • No data
  • During U.S. clinical trials with n cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of n cream.
  • In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
  • After the skin is thoroughly washed and patted dry, a thin film of n cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of n cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.
  • AZELEX
  • 30 g - NDC 16110-869-3050 g - NDC 16110-869-50
  • Storage:
  • Revised: 06/2019
  • Distributed under license by Almirall, LLC, Exton, PA 19341, U.S.A.u00a9 2019 Almirall. All right reserved. u00ae marks owned by Almirall, LLC.
  • Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy
  • No data
  • No data
  • No data
  • No data

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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