Suppliers and packagers for generic pharmaceutical drug: MEDROXYPROGESTERONE ACETATE

MEDROXYPROGESTERONE 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
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	020246	NDA	Pharmacia & Upjohn Company LLC	0009-0746-30	1 VIAL in 1 CARTON (0009-0746-30) / 1 mL in 1 VIAL	1992-10-29
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	020246	NDA	Pharmacia & Upjohn Company LLC	0009-0746-35	25 VIAL in 1 PACKAGE (0009-0746-35) / 1 mL in 1 VIAL	1992-10-29
Pfizer	DEPO-PROVERA	medroxyprogesterone acetate	INJECTABLE;INJECTION	020246	NDA	Pharmacia & Upjohn Company LLC	0009-7376-11	1 SYRINGE in 1 CARTON (0009-7376-11) / 1 mL in 1 SYRINGE	1992-10-29

Executive summary Medroxyprogesterone acetate (MPA) suppliers bifurcate into (1) finished-dose drug manufacturers that sell tablets, oral suspensions, injectables, and (2) upstream API and intermediate producers supplying MPA and related intermediates. A complete, citation-backed supplier map requires specific dosage form(s) and market scope (US vs EU vs RoW) because MPA supply chains differ by formulation and regulatory listing. If the scope is not defined, the supplier landscape cannot be stated accurately.

Medroxyprogesterone acetate API suppliers: Who makes the active pharmaceutical ingredient Which companies supply medroxyprogesterone acetate (MPA) API MPA API supply is typically handled by specialized generic API producers and some vertically integrated drug manufacturers. Supplier availability varies by:

• Molecule grade (USP/EP-comparable specs)
• Particle size and polymorph control needs for suspension or tablet performance
• Compliance status (GMP inspections for manufacturing sites)
• Access to key intermediates used in MPA synthesis

What intermediates and synthetic routes drive supplier qualification Common qualifying drivers for MPA API procurement include:

• Consistent impurity profile aligned to regulatory specs
• Ability to support change control for route and solvent system
• Analytical package (HPLC/GC methods, residual solvent and heavy metals)
• Stability program supporting intended retest and expiry windows

Upstream supplier due diligence points for buyers

• CEP or DMF status (where applicable)
• Batch release testing capability (sterility, microbial limits if relevant to a sterile product supply chain)
• Sterile-grade capability for injectable product supply, if the API supplier also supports sterile drug substance
• Traceability and audit history for US FDA and EU GMP compliance

Medroxyprogesterone acetate finished-dose suppliers: Who manufactures tablets, suspension, and injections What companies supply medroxyprogesterone acetate tablets and oral dosage forms Finished-dose tablets and oral suspensions are commonly sourced from generic manufacturers with mature oral solid oral product platforms. Supplier qualification depends on:

• Bioavailability and dissolution performance (especially for generics vs innovator)
• Formulation hold times and excipient supply stability
• Container closure system compatibility (especially for suspensions)

Which manufacturers supply medroxyprogesterone acetate injectable formulations MPA injectable supply tends to concentrate among companies that run sterile injectable lines and manage:

• Aseptic processing or terminal sterilization (product-specific)
• Microparticle suspension uniformity and re-suspension behavior
• Container fill and needle-compatibility testing

Injectables supply chain risks buyers track

• Single-site dependence for sterile filling
• Limited secondary packaging suppliers
• Compressed capacity windows around inspection cycles

How many medroxyprogesterone acetate suppliers exist by market and dosage form How does supplier count differ for US vs EU vs emerging markets Supplier density differs by jurisdiction due to:

• Regulatory entry requirements (ANDAs for US generics; national approvals or centralized routes in EU)
• Historical DMF/EDMF submissions for API
• Demand concentration in specific indications (contraception, endometrial protection, metastatic breast cancer palliation, and abnormal uterine bleeding regimens where MPA is used)

What is the practical supplier universe for procurement In practice, buyers narrow to:

• 2 to 5 qualified API sources per dosage form to manage continuity of supply
• 1 to 3 viable finished-dose vendors for constrained supply periods
• Back-up suppliers with smaller allocations that can ramp during shortages

Orange Book status: How supplier choice maps to branded vs generic listings What is the Orange Book status of medroxyprogesterone acetate products Orange Book status is product-specific and changes by dosage form and strength. Supplier strategy often links to:

• Whether a product is branded or generic
• Patent estate constraints affecting launch timing
• Whether the product is marketed as an ANDA generic, authorized generic, or innovator

Procurement implication of exclusivity and patent lock

• Launch timing affects near-term supplier competition and pricing
• Competitive dynamics differ for tablets versus injectables
• Authorized generics can compress margins and alter lead times

What patent and manufacturing IP barriers affect medroxyprogesterone acetate supply How do formulation and manufacturing process patents affect supplier entry Even when MPA is off-patent, formulation and process patents can delay generic entry for specific presentations. Barriers can include:

• Specific suspension formulation approaches
• Fill-finish process parameters for sterile injectables
• Device and administration-related claims for certain kits

Do supply shortages arise from IP, API constraints, or sterile capacity Common drivers of MPA supply tightness include:

• API sourcing interruptions or impurity-spec excursions
• Sterile manufacturing slot constraints
• Raw material allocation problems tied to seasonal demand or inspections

How does medroxyprogesterone acetate compare across suppliers on quality and cost What distinguishes “best-cost” from “continuity” suppliers Procurement selection typically weights:

• On-time delivery record and batch reliability
• Ability to supply consistent particle size and viscosity targets (critical for suspensions)
• Analytical method transfer readiness and documentation strength
• Contract manufacturing flexibility for volume swings

What quality metrics matter for MPA shipments

Last updated: May 26, 2026

• Impurity control and CoA consistency across lots
• Stability-indicating assay consistency
• Microbial and endotoxin controls for sterile contexts
• Delivery condition controls (temperature excursion management)

What generic entry risks exist for medroxyprogesterone acetate Does supplier consolidation raise barrier-to-entry risk If manufacturing lines for sterile injectables or specific oral forms consolidate under a few vendors, new entry can face:

• Capacity bottlenecks
• Higher inspection scrutiny
• Supply chain leverage held by a small set of excipient and packaging suppliers

What is the typical approach to reduce single-source risk Buyers mitigate single-source exposure through:

• Dual-sourcing for API and finished-dose
• Qualification of alternate container closure systems (for stability fit)
• Safety stock policies aligned to regulatory release time and batch lead times

Key Takeaways

• Supplier landscapes for medroxyprogesterone acetate differ materially by dosage form (oral vs injectable) and by geography.
• API sourcing and finished-dose manufacturing are distinct supplier universes with different qualification requirements.
• Quality and manufacturing capability, especially sterile injectable fill-finish, often determine practical supplier availability more than the underlying molecule novelty.
• Patent and exclusivity status is product-specific and influences competitive supply but does not replace the need to map vendors to specific labeled presentations.

FAQs

1. Which suppliers are best for medroxyprogesterone acetate injectable sterile manufacturing?
2. How do I qualify an API supplier for medroxyprogesterone acetate impurity specs and particle control needs?
3. What differences matter between tablet and suspension manufacturing when selecting medroxyprogesterone acetate suppliers?
4. How does Orange Book listing by strength and dosage form affect medroxyprogesterone acetate sourcing strategy?
5. What documentation should a medroxyprogesterone acetate supplier provide for GMP and batch release (CoA, analytical methods, stability data)?

References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. EMA. “European Medicines Agency: Human medicines.” European Medicines Agency.