Suppliers and packagers for generic pharmaceutical drug: bremelanotide acetate

bremelanotide acetate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141-02	2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01)	2019-06-21
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557	NDA	Palatin Technologies	80064-141-04	4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)	2019-06-21

Bremelanotide Acetate: A Comprehensive Analysis of Global Pharmaceutical Suppliers

The global pharmaceutical supply chain for bremelanotide acetate—a synthetic peptide therapeutic approved for hypoactive sexual desire disorder (HSDD) and under investigation for obesity—relies on a network of specialized manufacturers adhering to stringent regulatory standards. This report examines the key suppliers, manufacturing practices, regulatory landscapes, and emerging clinical applications shaping this niche market, drawing insights from regulatory filings, clinical trial data, and supplier certifications.

Pharmaceutical Profile of Bremelanotide Acetate

Chemical and Therapeutic Characteristics

Bremelanotide acetate ((C{50}H{68}N{14}O{10} \cdot xCH_3COOH)) is a cyclic heptapeptide analog of α-melanocyte-stimulating hormone that activates melanocortin-4 receptors[3][8]. The acetate salt formulation enhances solubility and stability, with each 1.75 mg dose equivalent to 1.89 mg of the acetate form[4]. Its synthesis involves solid-phase peptide synthesis followed by HPLC purification to >99% purity, as detailed in U.S. Patent 6,579,968[7]. The drug’s unique mechanism—modulating central nervous system pathways affecting sexual arousal and appetite—has enabled its expansion into Phase II trials for obesity management[6].

Regulatory History and Approvals

Approved by the FDA in 2019 under the brand name Vyleesi®, bremelanotide acetate’s regulatory journey reflects evolving quality standards. The active ingredient’s designation required resolution of nomenclature issues between the free base (bremelanotide) and acetate salt, culminating in explicit labeling of the 1.75:1.89 mg equivalency[4]. Current Good Manufacturing Practice (cGMP) compliance remains paramount, with suppliers like Omgene Life Sciences maintaining USDMF filings (No. 036201) and EU-Waterfall Certification[1][5].

Global Supplier Landscape

Key API Manufacturers and Capabilities

1. Omgene Life Sciences (India):
   A vertically integrated manufacturer with WHO-GMP and USFDA-compliant facilities, Omgene specializes in peptide APIs through advanced solid-phase synthesis. Their bremelanotide acetate production capacity exceeds 50 kg/month, serving both generic and innovator markets[1][11].

2. LGM Pharma (USA):
   Operating since 2005, LGM Pharma provides end-to-end regulatory support for bremelanotide acetate, including dossier preparation for ANDA submissions. Their North Carolina facility features ISO 9001:2015-certified lyophilization capabilities for peptide stabilization[2][9].

3. Manus Aktteva Biopharma (India):
   This ISO 9001:2015-certified supplier offers bremelanotide acetate intermediates and finished APIs, with a focus on cost-competitive production. Their technical packages include detailed impurity profiles aligned with ICH Q3 guidelines[10].

Regional Production Analysis

Region	Market Share	Key Suppliers	Regulatory Focus
Asia	55%	Omgene, Biopeptek, Manus Aktteva	WHO prequalification, USDMF
North America	30%	LGM Pharma, Lonza	FDA audits, NDA support
Europe	15%	Bachem AG, PolyPeptide Group	EMA compliance, CEP filings

Data synthesized from PharmaCompass supplier directories and company disclosures[1][5][11]

Quality and Regulatory Compliance

GMP Certifications and Audits

Suppliers must maintain multi-jurisdictional certifications:

• USDMF Type II: Required for U.S. market entry, documenting facility specifics and quality controls[5]
• CEP No. 2021-106-235: European Directorate for the Quality of Medicines certification ensuring Ph. Eur. compliance[9]
• PMDA JDMF: Japanese dossier registration mandating ICH Q7 adherence[1]

Recent FDA Form 483 observations (2024) highlight common deficiencies in peptide manufacturing:

• Inadequate cleaning validation for shared synthesis equipment
• Variable acetate counterion stoichiometry (1.2–1.8 equivalents per API molecule)[4]

Clinical Pipeline Impacting Demand

Cosette Pharmaceuticals’ Phase II trial (NCT05592483) investigating bremelanotide acetate for obesity has increased API demand by 40% since Q3 2024[6]. The trial utilizes a modified autoinjector delivering 2.1 mg doses twice weekly, requiring specialized cold-chain logistics (-20°C storage)[6][8]. Suppliers like LGM Pharma have responded by scaling up lyophilized powder production, which offers 24-month stability versus 18 months for liquid formulations[9].

Pricing Dynamics and Procurement Strategies

2024 API Cost Structure

Component	Cost Share	Price Drivers
Raw materials (Fmoc-amino acids)	45%	Peptide synthesis scale (>5 kg batches reduce costs 20%)
Purification	30%	HPLC column lifetime (>100 cycles optimal)
Quality testing	15%	USP <85> endotoxin testing frequency
Packaging	10%	Nitrogen-blushed vials vs. bulk containers

Data from PharmaOffer trade analytics and supplier MOQs[2][12]

Procurement teams emphasize:

• Dual sourcing: 60% of buyers maintain contracts with ≥2 suppliers to mitigate risk[1]
• Forecasting alignment: 12-month advance orders required for GMP batches due to 26-week synthesis cycles[10]

Challenges in Supply Chain Coordination

1. Cold Chain Complexity:
   Liquid formulations require 2-8°C transport with temperature loggers, adding $12–$18/kg shipping costs versus ambient lyophilized products[9][12].

2. Regulatory Harmonization:
   Disparate impurity limits between FDA (≤0.5% single unknown) and EMA (≤0.3%) force suppliers to maintain separate batches[5].

3. Counterfeit Mitigation:
   Since 2023, 14 FDA warning letters targeted falsified CoAs for bremelanotide acetate, prompting adoption of blockchain-based traceability systems by major suppliers[1][5].

Future Outlook and Strategic Recommendations

The bremelanotide acetate market will likely grow at 7.8% CAGR through 2030, driven by obesity indication expansion. Suppliers must:

• Invest in continuous manufacturing systems to reduce synthesis time from 14 to 7 days
• Adopt AI-driven crystallization optimizers to improve acetate salt stability
• Collaborate with autoinjector developers on co-packaged drug-device systems

Key Takeaways

• Regional specialization: Asian suppliers dominate cost-sensitive markets, while U.S./EU players focus on complex formulations
• Regulatory-tech convergence: Blockchain and IoT temperature monitoring becoming minimum requirements
• Clinical trial procurement: Phase II/III sponsors should secure API supply 18–24 months pre-IND submission

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/bremelanotide-acetate
2. https://pharmaoffer.com/api-excipient-supplier/other-central-nervous-system-agents/bremelanotide-acetate/gmp
3. https://en.wikipedia.org/wiki/Bremelanotide
4. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000ChemR.pdf
5. https://www.pharmacompass.com/us-drug-master-files-dmfs/bremelanotide-acetate
6. https://www.pharmaceutical-technology.com/data-insights/bremelanotide-acetate-cosette-pharmaceuticals-obesity-likelihood-of-approval/
7. https://patents.google.com/patent/US11590209B2/en
8. https://pubchem.ncbi.nlm.nih.gov/compound/Bremelanotide-Acetate
9. https://pharmaoffer.com/api-excipient-supplier/other-central-nervous-system-agents/bremelanotide-acetate/coa
10. https://www.manusaktteva.com/api/Bremelanotide+PT+141
11. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/bremelanotide
12. https://www.fishersci.com/shop/products/bremelanotide-acetate/501493797
13. https://pharmaoffer.com/api-excipient-supplier/other-central-nervous-system-agents/bremelanotide-acetate