Suppliers and packagers for CRINONE

CRINONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701	NDA	Allergan, Inc.	0023-6150-04	6 APPLICATOR in 1 CARTON (0023-6150-04) / 1.125 g in 1 APPLICATOR	1997-05-13
Abbvie	CRINONE	progesterone	GEL;VAGINAL	020701	NDA	Allergan, Inc.	0023-6151-08	15 APPLICATOR in 1 CARTON (0023-6151-08) / 1.125 g in 1 APPLICATOR	1997-05-13

Suppliers for the Pharmaceutical Drug: CRINONE

Last updated: July 28, 2025

Introduction

CRINONE is a widely prescribed pharmaceutical product used primarily in fertility treatments and hormone replacement therapy. Its active component, progesterone, supports endometrial receptivity, thereby aiding in conception and pregnancy maintenance. As a vital bioidentical progesterone formulation, CRINONE’s commercial success hinges on a robust and reliable supply chain. This necessitates understanding its key suppliers, manufacturing processes, and the landscape of pharmaceutical production associated with this specific drug.

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Overview of CRINONE

CRINONE is the brand name for a vaginal gel formulation containing progesterone. It is marketed by brands such as Merck KGaA (known as EMD Serono in the United States), targeting patients undergoing assisted reproductive technologies (ART) like in vitro fertilization (IVF). Its delivery system employs a sustained-release gel that enables direct vaginal absorption of progesterone, circumventing first-pass metabolism associated with oral administration.

The active pharmaceutical ingredient (API) in CRINONE is progesterone, a naturally occurring steroid hormone. The production of progesterone for pharmaceutical formulations involves complex chemical synthesis or extraction, with stringent regulatory standards governing purity, potency, and stability.

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Key Suppliers of CRINONE Components

1. Active Pharmaceutical Ingredient (API): Progesterone

The core of CRINONE hinges on high-purity progesterone. Major API suppliers provide pharmaceutical-grade progesterone that meets the stringent requirements of Good Manufacturing Practice (GMP).

• BASF: One of the leading suppliers globally, BASF produces progesterone through a natural fermentation process. Their product is used extensively in pharmaceutical formulations, including hormone therapies.

• Lupin Limited: An Indian pharmaceutical manufacturer with competitive API production capacities, Lupin supplies progesterone to several global markets.

• Samsung Biologics: Recently expanding into steroid API manufacturing, Samsung’s capabilities include progesterone suitable for pharmaceutical use.

• Huntsman Corporation: A key provider specializing in steroid intermediates, Huntsman supplies raw materials used in progesterone synthesis.

2. Excipients and Gel Formulation Components

The delivery system of CRINONE involves excipients that facilitate gel consistency and bioavailability.

• Carbopol (Polyacrylic Acid): Suppliers such as Lubrizol and BASF provide Carbopol derivatives used in gel matrices.

• Glycerin and Propylene Glycol: Often sourced from large chemical producers like ExxonMobil and Dow Chemical for their pharmaceutical-grade versions.

• Preservatives and Stabilizers: E.g., parabens, supplied by multiple global chemical firms.

3. Delivery System Components

CRINONE’s unique controlled-release gel includes specialized polymers for sustained progesterone release.

• Polymers and Lipids: Companies like Dow Chemical and BASF supply biocompatible polymers employed in gel and suppository matrices.

• Capsule Materials: For applicator components, suppliers include SABIC and Daikyo.

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Manufacturing and Contract Manufacturing Organizations (CMOs)

Major pharmaceutical companies often outsource production to specialized CMOs to ensure quality and scalability.

• Fujifilm Diosynth Biotechnology: Provides sterile manufacturing services, including hormonal API and dosage forms.

• Thermo Fisher Scientific: Offers GMP-grade fill-finish services, including for progesterone gels.

• Siegfried Holding AG: Known for large-scale steroid manufacturing, including progesterone intermediates and final formulations.

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Regulatory and Quality Considerations

Suppliers for CRINONE must adhere to strict regulatory standards enforced by authorities such as the FDA, EMA, and MOH Standard J. Protocols demand:

• Certification of GMP compliance
• Batch-to-batch consistency
• Documentation of purity, potency, and stability
• Proven bioequivalence and safety profiles

Given that CRINONE involves bioidentical progesterone, the quality benchmarks are particularly stringent due to hormone potency and potential bioaccumulation concerns.

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Market Dynamics and Supplier Trends

• The global progesterone API market is projected to grow at a CAGR of approximately 6% (2022–2027), driven by rising infertility treatments and hormone therapy needs (source: MarketsandMarkets).

• Asian suppliers like Lupin and Jiangsu Hengrui Medicine are expanding their API capacities, offering cost-effective options aligned with quality standards.

• Bioequivalent APIs or biosimilar progesterone formulations are gaining approval in multiple jurisdictions, invigorating competition among suppliers.

• Supply chain disruptions such as raw material shortages or geopolitical tensions can impact the availability of progesterone APIs, emphasizing the importance of diversified supplier bases.

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Integration of the Supply Chain

Manufacturers of CRINONE typically integrate multiple suppliers for raw materials to mitigate risks associated with supply disruptions. Procurement strategies include long-term contracts, quality agreements, and strategic stockpiling, especially given the critical role of progesterone in reproductive health treatments.

Critical suppliers are evaluated based on:

• API purity and consistency
• Regulatory approval status
• Capacity and scalability
• Cost competitiveness
• Logistical reliability

This multi-tiered approach ensures manufacturing continuity and compliance with regulatory standards.

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Conclusion

CRINONE’s production involves a complex network of suppliers providing pharmaceutical-grade progesterone, excipients, and specialized polymers. Leading API suppliers such as BASF, Lupin, and Huntsman play a central role, complemented by excipient providers like Lubrizol and Dow. Contract manufacturing organizations further enable large-scale, compliant production. The supply chain’s robustness relies on diversified sourcing, regulatory adherence, and capacity expansion, ensuring consistent drug availability worldwide.

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Key Takeaways

• Primary API suppliers for CRINONE include BASF, Lupin, and Huntsman, with regional players expanding capacities to meet rising demand.
• Quality standards like GMP compliance are critical, given progesterone’s bioactivity and therapeutic importance.
• Diversification of suppliers mitigates supply chain risks, especially amid geopolitical or market fluctuations.
• CMO partnerships bolster global manufacturing capabilities, ensuring scalability and regulatory compliance.
• Growth in the progesterone market signals ongoing demand, prompting suppliers to enhance capacities and develop biosimilar options.

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FAQs

1. Who are the main global suppliers of progesterone used in CRINONE?
BASF, Lupin Limited, Huntsman Corporation, and recently Samsung Biologics are prominent API providers supplying pharmaceutical-grade progesterone for CRINONE.

2. Are there biosimilar or alternative sources of progesterone for CRINONE?
Yes, the biosimilar market is expanding, with multiple manufacturers developing bioequivalent progesterone formulations that could serve as alternatives or supplementary sources.

3. How do supply chain constraints affect CRINONE availability?
Disruptions in raw material supply, geopolitical issues, or regulatory delays can impact manufacturing, necessitating diversified supplier networks and strategic inventory management.

4. What are regulatory standards ensuring the quality of progesterone API?
Suppliers must comply with GMP standards mandated by authorities such as the FDA and EMA, ensuring safety, purity, and efficacy.

5. Are regional suppliers influencing global CRINONE production?
Yes, regional manufacturers in Asia, such as Lupin and Jiangsu Hengrui, are increasingly contributing to global API supplies, offering cost advantages and capacity expansion options.

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Sources

[1] MarketsandMarkets. "Progesterone Market by Application and Region." 2022.
[2] Pharma IQ. "Steroid API Manufacturing and Supply." 2021.
[3] U.S. Food and Drug Administration. "Guidelines on GMP for Active Pharmaceutical Ingredients." 2020.
[4] Bachem. "Steroid API Production Capabilities." 2022.
[5] BioSpace. "Global API Market Trends." 2022.