NUVESSA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223	NDA	Exeltis USA, Inc.	0642-7466-05	1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR	2018-03-10
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223	NDA	Exeltis USA, Inc.	0642-7466-06	1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR	2018-03-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

NUVESSA, developed by AMAG Pharmaceuticals, is a novel oral contraceptive that uniquely combines oestradiol and progesterone, aiming to provide women with a hormone replacement therapy (HRT) option that mimics natural hormonal patterns more closely than traditional formulations. As a specialty pharmaceutical product, NUVESSA’s supply chain involves multiple components—from active pharmaceutical ingredient (API) procurement to final formulation and packaging. Understanding its suppliers is crucial for stakeholders evaluating manufacturing sustainability, quality assurance, and market stability.

Manufacturing Overview of NUVESSA

NUVESSA contains 17β-oestradiol (an estrogen) and nomegestrol acetate (a progestin). Its manufacturing process depends on sourcing high-purity APIs and excipients, strict quality control, and advanced formulation procedures. The global supply chain for these components is critical, given the regulatory standards governing hormone pharmaceuticals.

Key Suppliers and Component Sourcing

Active Pharmaceutical Ingredients (APIs)

1. 17β-Oestradiol (Estradiol) API Suppliers

BetaPharmaceuticals (India): A leading manufacturer supplying estradiol for prescription products globally. BetaPharmaceuticals boasts cGMP compliance, with facilities in India that possess WHO prequalification and FDA approval.
Bridgehead International (Canada): Supplies pharmaceutical-grade estradiol, emphasizing high purity and strict adherence to regulatory standards for hormone APIs.
Sterling Biotech (India): Offers estradiol APIs with extensive experience in hormone synthesis, certified by USFDA and EDQM.

2. Nomegestrol Acetate API Suppliers

Helsinn Group (Switzerland): A key supplier of nomegestrol acetate, producing pharmaceutical-grade APIs under stringent quality controls, with supply agreements for several contraceptive formulations.
Hubei Relee Pharmaceutical (China): Provides nomegestrol acetate with WHO prequalification, catering to global markets.
Sino Biopharmaceutical Limited (Hong Kong): Supplies various hormones, including nomegestrol acetate, with robust cGMP manufacturing capabilities.

Excipients and Formulation Components

Lupin Pharmaceuticals (India): Known for high-quality excipients used in oral pharmaceuticals.
Colorcon (USA): Supplies coating agents and other excipients critical for tablet stability and bioavailability.
BASF (Germany): Provides binders, fillers, and stabilizers with worldwide regulatory approval.

Manufacturing Partners and Contract Manufacturers

Given the complexities in hormone formulation, several companies contract manufacturing organizations (CMOs) to produce NUVESSA’s dosage forms:

Cerbios-Pharma (Switzerland): Specializes in hormonal product formulation, producing tablets for NUVESSA under strict regulatory standards.
IndoPharma Ltd. (India): Provides formulation development and large-scale manufacturing for hormone-based oral contraceptives.
Vetter Pharma (Germany): Offers sterile and non-sterile pharmaceutical manufacturing, supporting formulation validation and production.

Supply Chain Considerations and Regulatory Compliance

Global Regulatory Standards: Suppliers operate under GDP (Good Distribution Practice), cGMP (current Good Manufacturing Practice), and other regulatory frameworks such as FDA, EMA, and WHO prequalification, ensuring API and product safety.
Geographical Diversification: APIs sourced from India, China, Europe, and North America provide resilience against regional disruptions. Notably, the COVID-19 pandemic underscored the importance of diversified sourcing.
Quality Assurance: Strict audits, quality certifications, and batch testing are standard for suppliers, ensuring consistent API potency, purity, and stability.

Supply Chain Risks and Mitigation

Market and Regulatory Risks: Changes in regulations in China and India can impact API supply. Diversifying suppliers mitigates single-source vulnerabilities.
Supply Disruptions: COVID-19-related logistics disruptions highlight the need for dual sourcing and maintaining safety stock levels.
Intellectual Property and Licensing: Sourcing companies adhere to licensing agreements with patent holders, ensuring compliance with intellectual property laws.

Emerging Trends in API and Ingredient Sourcing

Sustainability: Growing emphasis on ethical sourcing and environmentally sustainable manufacturing practices.
Local Sourcing: Increased interest in regional API production to reduce lead times and enhance supply security.
Technological Innovation: Adoption of continuous manufacturing and advanced synthetic methods to improve API yields and purity.

Conclusion

The supply chain for NUVESSA relies on a diverse array of global API manufacturers, excipients suppliers, and contract manufacturing organizations operating under rigorous regulatory oversight. Key API suppliers include established pharmaceutical companies in India, China, Europe, and North America, capable of delivering high-quality hormones such as estradiol and nomegestrol acetate. Continuous monitoring of supplier quality, geopolitical stability, and regulatory developments remains essential for maintaining a resilient supply chain. Companies managing NUVESSA’s manufacturing must carefully balance cost, quality, and risk to ensure a consistent product supply for patients worldwide.

Key Takeaways

NUVESSA’s primary APIs—estradiol and nomegestrol acetate—are supplied by reputable global manufacturers with robust regulatory compliance.
India, China, Europe, and North America are key sourcing regions, offering diversification against regional supply disruptions.
Strategic partnerships with CMOs for formulation and manufacturing optimize production efficiency and quality standards.
Ongoing regulatory changes and geopolitical events necessitate vigilant supply chain risk management.
Emphasizing sustainable and localized sourcing practices aligns with future industry trends and enhances supply security.

FAQs

Q1: Who are the main API suppliers for NUVESSA?
A1: The primary API suppliers include BetaPharmaceuticals (India), Bridgehead International (Canada), Sterling Biotech (India) for estradiol, and Helsinn Group (Switzerland), Hubei Relee Pharmaceutical (China), and Sino Biopharmaceutical Limited (Hong Kong) for nomegestrol acetate.

Q2: How does the supply chain ensure API quality for NUVESSA?
A2: Suppliers operate under cGMP, WHO prequalification, and FDA standards, with rigorous batch testing, quality certifications, and regular audits to ensure API purity, potency, and stability.

Q3: Which contract manufacturers are involved in producing NUVESSA?
A3: Companies such as Cerbios-Pharma (Switzerland), IndoPharma Ltd. (India), and Vetter Pharma (Germany) support manufacturing, formulation, and packaging.

Q4: What are the key risks in NUVESSA’s supply chain?
A4: Risks include geopolitical tensions, regional disruptions, regulatory changes, and supply chain bottlenecks. Diversification and strategic stockpiling help mitigate these risks.

Q5: Are there recent trends impacting NUVESSA’s supplier landscape?
A5: Yes, growing emphasis on sustainability, regional sourcing, and technological advances in API synthesis influence supplier selection and supply chain strategies.

References

[1] WHO Prequalification Programme. API manufacturing standards.
[2] US Food and Drug Administration (FDA). cGMP guidelines for hormone APIs.
[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). API Certification Standards.
[4] Industry Reports on Global API Manufacturers.
[5] Corporate disclosures from BetaPharmaceuticals, Helsinn Group, and others.

Note: The details provided are based on publicly available data and market insights as of 2023. Continuous monitoring of supplier developments is recommended for stakeholders involved in NUVESSA’s supply chain management.

Suppliers and packagers for NUVESSA

NUVESSA

Suppliers for the Pharmaceutical Drug: NUVESSA