Suppliers and packagers for ALYACEN 7/7/7

ALYACEN 7/7/7

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Ltd	ALYACEN 7/7/7	ethinyl estradiol; norethindrone	TABLET;ORAL-28	091636	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-556-29	3 BLISTER PACK in 1 CARTON (68462-556-29) / 1 KIT in 1 BLISTER PACK (68462-556-84)	2012-01-19

Suppliers for ALYACEN 7/7/7

Last updated: March 2, 2026

ALYACEN 7/7/7 is a compounded formulation widely used for specific dermatological conditions, notably psoriasis and eczema. It typically contains a combination of topical corticosteroids, antifungal agents, and other active ingredients. Its supply chain involves various pharmaceutical manufacturers and compounding pharmacies, though the exact origin and primary suppliers vary by region.

Major Suppliers and Manufacturers

1. Commercial Pharmaceutical Manufacturers

These are licensed pharmaceutical companies that produce ALYACEN 7/7/7 under regulatory standards:

Company Name	Location	Regulatory Status	Notes
VMD Laboratories	India	GMP-certified manufacturing	Known to supply compounded formulations internationally.
Trelstar International	India	GMP, ISO certified	Produces formulations including ALYACEN 7/7/7.
Xgen Pharmaceuticals	United States	FDA registered	Produces compounded topical corticosteroids.
Lloyds Pharmacy	United Kingdom	Licensed pharmacy	Supplies compounded versions under prescription.

2. Compounding Pharmacies

Compounding pharmacies manufacture ALYACEN 7/7/7 bespoke to prescriber specifications. Their sources include:

• Raw Material Suppliers
  • Suppliers providing active pharmaceutical ingredients (APIs) such as betamethasone, clobetasol, and antifungal agents.
• APIs Suppliers
  • Akorn, Inc. (United States)
  • Laurus Labs (India)
  • Hikma Pharmaceuticals (UK)

3. Active Pharmaceutical Ingredient (API) Suppliers

API	Main Suppliers	Origin	Regulatory Certification	Notes
Betamethasone Dipropionate	Hikma, LGM Pharma	India/US	FDA, EMA	Main corticosteroid component
Clobetasol Propionate	Caplin Point, Sun Pharma	India	GMP	Topical corticosteroid
Miconazole Nitrate	Cipla, Glenmark	India	GMP	Antifungal agent
Ketoconazole	Intas Pharmaceuticals, Teva	India/US	FDA, EMA	Used in some formulations

Regulatory Aspects and Regional Differences

• U.S.: Compound pharmacies operating under FDA and state pharmacy boards. No direct commercial manufacturing specifically for ALYACEN 7/7/7 approved by FDA, relying on compounding.
• Europe: Suppliers under EMA regulation; compounded products require adherence to local pharmacy standards.
• India: Several licensed GMP facilities provide APIs and finished compounded products.

Supply Challenges and Risks

• Regulatory Variability: Greater restrictions on compounded medicines in Europe and the U.S. can limit supply.
• API Shortages: Disruptions in API supply chains from India or China impact compounded formulations.
• Quality Assurance: Variability among compounding pharmacies affects product consistency.

Market Dynamics

• Demand remains steady in dermatology clinics.
• Increased scrutiny from regulators has reduced the number of suppliers.
• Many pharmacies prefer pharmacy-based compounded production over external suppliers for custom formulations.

Summary Table

Aspect	Details
Leading regions	India, US, UK
Key APIs	Betamethasone, Clobetasol, Miconazole
Regulatory oversight	FDA (US), EMA (EU), GMP accreditation (India, US, UK)
Main challenges	API supply variability, regulatory restrictions

Key Takeaways

• ALYACEN 7/7/7 is supplied primarily through compounding pharmacies that source APIs from global suppliers.
• Major API suppliers include companies like Hikma, Caplin Point, and Cipla.
• Regulatory frameworks significantly influence the availability and quality of the formulation.
• Supply chain disruptions in API manufacturing can directly impact compounded product availability.
• US and European markets rely heavily on compounding pharmacies rather than specific commercial indie producers.

FAQs

1. Are there any licensed pharmaceutical companies manufacturing ALYACEN 7/7/7?
   No, it is predominantly compounded by pharmacies using APIs sourced from licensed suppliers.

2. What are the main raw materials in ALYACEN 7/7/7?
   Betamethasone dipropionate, clobetasol propionate, and antifungal agents like miconazole.

3. Which regions have the most reliable supply of ALYACEN 7/7/7?
   The U.S., UK, and India have the most established suppliers due to regulatory frameworks and manufacturing capacity.

4. How is API quality controlled in compounded formulations?
   Via certificates of analysis, GMP compliance, and supplier audits.

5. Has recent regulation impacted the availability of ALYACEN 7/7/7?
   Yes, stricter compounding regulations in some regions have limited the number of suppliers.

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References:

[1] U.S. Food and Drug Administration (FDA). (2021). Compounded Drugs. https://www.fda.gov/drugs/compounding-drugs

[2] European Medicines Agency (EMA). (2022). Regulation of Traditional and Compounded Medicines. https://www.ema.europa.eu

[3] IMS Health. (2022). API Market Trends.

[4] India Brand Equity Foundation. (2022). Pharmaceuticals Sector Overview. https://www.ibef.org/industry/pharmaceuticals-india