DEPO-SUBQ PROVERA 104: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DEPO-SUBQ PROVERA 104	medroxyprogesterone acetate	INJECTABLE;SUBCUTANEOUS	021583	NDA	Pharmacia & Upjohn Company LLC	0009-4709-13	1 SYRINGE in 1 CARTON (0009-4709-13) / .65 mL in 1 SYRINGE	2005-05-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes the supply chain for DEPO-SUBQ PROVERA 104, a long-acting injectable contraceptive. The analysis identifies key suppliers for active pharmaceutical ingredient (API) and finished drug product manufacturing, along with relevant regulatory and intellectual property considerations.

What is the Composition of DEPO-SUBQ PROVERA 104?

DEPO-SUBQ PROVERA 104 is a sterile, aqueous suspension of medroxyprogesterone acetate (MPA). The API is micronized medroxyprogesterone acetate. The formulation also contains excipients.

Active Pharmaceutical Ingredient (API): Medroxyprogesterone acetate (MPA)
Excipients: Water for injection, sodium chloride, polysorbate 20, polyethylene glycol 3350, and benzalkonium chloride. [1]

Who Manufactures the Active Pharmaceutical Ingredient (API)?

The manufacturing of medroxyprogesterone acetate (MPA) is a complex, multi-step chemical synthesis. Identifying the specific contract manufacturing organizations (CMOs) or internal manufacturing sites responsible for MPA production for DEPO-SUBQ PROVERA 104 is challenging due to proprietary supplier relationships. However, based on general industry knowledge of API production for hormonal contraceptives, several established pharmaceutical ingredient manufacturers are likely candidates or potential suppliers.

Key characteristics of MPA API suppliers typically include:

cGMP Compliance: Adherence to Current Good Manufacturing Practices (cGMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Specialized Synthesis Capabilities: Expertise in steroid synthesis, which involves complex organic chemistry.
Quality Control & Assurance: Robust systems for testing raw materials, intermediates, and the final API to ensure purity, potency, and stability.
Supply Chain Security: Mechanisms to ensure a consistent and reliable supply of the API.

Potential types of MPA API suppliers include:

Large, Vertically Integrated Pharmaceutical Companies: Companies that manufacture their own APIs for key products.
Specialized API Manufacturers: CMOs that focus on the production of complex APIs, including steroids.
Global API Hubs: Regions with established pharmaceutical manufacturing infrastructure and expertise, such as India and China, often host API manufacturers.

While specific supplier names for DEPO-SUBQ PROVERA 104 are not publicly disclosed by Pfizer (the marketer), typical global suppliers of steroid APIs used in contraceptives include companies with strong track records in this therapeutic area. Due diligence on potential API suppliers would involve reviewing their regulatory history, manufacturing capacity, quality systems, and financial stability.

Who Manufactures the Finished Drug Product?

The finished drug product, DEPO-SUBQ PROVERA 104, is a sterile injectable suspension. Its manufacturing requires specialized facilities capable of aseptic processing, filling, and finishing. The marketing authorization holder is responsible for ensuring the quality and compliance of the manufacturing site.

Pfizer, as the marketer of DEPO-SUBQ PROVERA 104, is likely to have its own manufacturing facilities or utilize contract manufacturing organizations (CMOs) for the production of the finished dosage form. The sterile manufacturing of injectable suspensions involves:

Aseptic Processing: Manufacturing under sterile conditions to prevent microbial contamination.
Micronization: Ensuring the API is processed to the required particle size for suspension stability and bioavailability.
Formulation and Blending: Combining the API with excipients in precise proportions.
Filling and Lyophilization (if applicable): Filling the sterile suspension into vials or syringes.
Inspection and Packaging: Quality control checks and packaging of the final product.

Information regarding the specific CMOs or internal Pfizer sites manufacturing DEPO-SUBQ PROVERA 104 is generally considered proprietary. However, companies that specialize in sterile injectable manufacturing and have a history of producing contraceptives are typically engaged for such operations.

What are the Regulatory Considerations for Suppliers?

Suppliers involved in the DEPO-SUBQ PROVERA 104 supply chain must comply with stringent regulatory requirements. These regulations are designed to ensure the safety, efficacy, and quality of pharmaceutical products.

API Suppliers

cGMP Compliance: API manufacturers must adhere to cGMP guidelines, which cover all aspects of production and quality control. This includes facility design, equipment qualification, personnel training, process validation, and documentation. [2]
Drug Master Files (DMFs): API suppliers typically submit DMFs to regulatory agencies (e.g., FDA, EMA). These confidential documents contain detailed information about the manufacturing process, facilities, and controls for the API. Drug product manufacturers can then reference these DMFs in their marketing applications. [3]
Audits and Inspections: Regulatory agencies conduct inspections of API manufacturing sites to verify cGMP compliance. Marketing authorization holders also conduct audits of their API suppliers.
Change Control: Any changes to the manufacturing process, facility, or materials must be evaluated for their impact on API quality and reported to regulatory agencies and the drug product manufacturer.

Finished Drug Product Manufacturers

cGMP Compliance: Facilities manufacturing the finished drug product must also comply with cGMP regulations specific to finished dosage forms. This includes sterile manufacturing requirements. [2]
Marketing Authorization Holder Responsibility: The marketing authorization holder is ultimately responsible for the quality of the finished drug product, regardless of where it is manufactured.
Facility Inspections: Regulatory agencies inspect finished drug product manufacturing facilities regularly.
Product Quality: Manufacturers must demonstrate consistent product quality, including assay, purity, dissolution (if applicable), sterility, and stability.
Pharmacovigilance: Systems for monitoring and reporting adverse events related to the finished product are mandatory.

What is the Intellectual Property Landscape?

The intellectual property (IP) surrounding DEPO-SUBQ PROVERA 104 primarily involves patents related to the drug itself, its formulation, and its methods of use. While the patent for the original DEPO-PROVERA® (medroxyprogesterone acetate injectable suspension) has long expired, specific formulations and manufacturing processes can be protected.

Key Patent Considerations

Composition of Matter Patents: These patents protect the chemical compound itself. Original patents for medroxyprogesterone acetate have expired.
Formulation Patents: Patents may cover specific formulations, such as the micronized particle size and excipient composition of DEPO-SUBQ PROVERA 104, which contribute to its sustained release profile. These patents can extend market exclusivity.
Method of Use Patents: Patents can protect specific indications or methods of administration.
Manufacturing Process Patents: Patents may be obtained for novel or improved manufacturing processes that offer advantages in efficiency, purity, or cost.
Exclusivity Periods: Regulatory exclusivity, such as New Chemical Entity (NCE) exclusivity or data exclusivity, can provide additional market protection independent of patents.

Companies seeking to manufacture generic versions of DEPO-SUBQ PROVERA 104 must navigate this IP landscape, conducting freedom-to-operate (FTO) analyses to ensure they do not infringe on existing patents. The expiration of key patents can pave the way for generic competition.

What is the Market Status and Competitive Landscape?

DEPO-SUBQ PROVERA 104 is a prescription contraceptive. Its market status is influenced by factors such as prescribing patterns, availability, and competition from other long-acting reversible contraceptives (LARCs) and short-acting methods.

Product: DEPO-SUBQ PROVERA 104
Therapeutic Area: Contraception
Dosage Form: Subcutaneous injection
API: Medroxyprogesterone acetate
Indication: Prevention of pregnancy

Competitive Products

The competitive landscape includes other injectable contraceptives and various forms of LARCs:

Other Injectable Contraceptives:
- DEPO-PROVERA® (medroxyprogesterone acetate injectable suspension - intramuscular)
- Sayana Press® (medroxyprogesterone acetate for subcutaneous injection)
Intrauterine Devices (IUDs):
- Levonorgestrel-releasing IUDs (e.g., Mirena, Kyleena, Liletta, Skyla)
- Copper IUDs (e.g., Paragard)
Implantable Contraceptives:
- Nexplanon (etonogestrel implant)
Oral Contraceptives: Combined and progestin-only pills.
Vaginal Rings and Patches:

The choice of contraceptive method by individuals and healthcare providers is influenced by efficacy, convenience, side effect profiles, cost, and patient preference.

Key Takeaways

The DEPO-SUBQ PROVERA 104 supply chain involves specialized manufacturing of medroxyprogesterone acetate (MPA) API and sterile injectable finished drug product.
API suppliers are likely to be experienced steroid manufacturers operating under strict cGMP compliance, potentially submitting Drug Master Files (DMFs).
Finished drug product manufacturing is expected to be conducted in aseptic facilities, either by Pfizer or through contract manufacturing organizations (CMOs).
All suppliers must adhere to rigorous regulatory standards set by agencies like the FDA and EMA.
Intellectual property, including formulation and process patents, plays a critical role in market exclusivity and generic competition.
DEPO-SUBQ PROVERA 104 competes with a range of other contraceptives, including other injectables, IUDs, and implants.

Frequently Asked Questions

What are the primary risks associated with the DEPO-SUBQ PROVERA 104 supply chain? Risks include API supply disruptions due to manufacturing issues, raw material shortages, or geopolitical factors; regulatory non-compliance by suppliers leading to product recalls or manufacturing halts; and patent expirations allowing for generic market entry.
How does the subcutaneous formulation of DEPO-SUBQ PROVERA 104 differ from intramuscular DEPO-PROVERA® in terms of manufacturing? While both use medroxyprogesterone acetate, the subcutaneous formulation requires precise control of particle size and suspension characteristics suitable for subcutaneous administration, which may necessitate distinct micronization and filling processes compared to the intramuscular version.
Are there specific requirements for excipient suppliers for sterile injectable suspensions like DEPO-SUBQ PROVERA 104? Yes, excipient suppliers must provide materials of pharmaceutical grade, meet pharmacopoeial specifications (e.g., USP, Ph. Eur.), and be manufactured under cGMP conditions. Documentation regarding the origin, purity, and stability of excipients is critical.
What are the typical timelines for regulatory approval of new API or finished product manufacturing sites for an established drug like DEPO-SUBQ PROVERA 104? For established drugs, the process typically involves submitting variations or amendments to the marketing authorization to update or add manufacturing sites. Regulatory review timelines can vary but generally range from several months to over a year, depending on the complexity of the submission and the agency's workload.
What due diligence is recommended when evaluating a potential supplier for DEPO-SUBQ PROVERA 104 components? Recommended due diligence includes reviewing the supplier's regulatory history (FDA Warning Letters, EMA inspection reports), cGMP compliance records, audit reports from other pharmaceutical clients, financial stability, manufacturing capacity, quality management system documentation, and their supply chain integrity protocols.

Citations

[1] Pfizer Inc. (n.d.). Depo-subQ Provera 104 prescribing information. Retrieved from https://labeling.pfizer.com/ShowLabeling.aspx?id=159

[2] U.S. Food and Drug Administration. (2023, August 17). Current Good Manufacturing Practice (cGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-drugs

[3] U.S. Food and Drug Administration. (2012, July 12). Drug Master Files: Content and Filing. Retrieved from https://www.fda.gov/drugs/forms-supplements-and-amendments/drug-master-files-content-and-filing

Suppliers and packagers for DEPO-SUBQ PROVERA 104