Suppliers and packagers for compro

compro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	COMPRO	prochlorperazine	SUPPOSITORY;RECTAL	040246	ANDA	Padagis US LLC	0574-7226-12	12 PACKET in 1 CARTON (0574-7226-12) / 1 SUPPOSITORY in 1 PACKET	2000-09-01
Padagis Us	COMPRO	prochlorperazine	SUPPOSITORY;RECTAL	040246	ANDA	PD-Rx Pharmaceuticals, Inc.	55289-119-02	2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-119-02)	2000-09-01
Padagis Us	COMPRO	prochlorperazine	SUPPOSITORY;RECTAL	040246	ANDA	PD-Rx Pharmaceuticals, Inc.	55289-119-06	6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-119-06)	2000-09-01

Suppliers and packagers for compro

Last updated: June 5, 2026

COMPRO (prochlorperazine) Suppliers: Who Manufactures and Supplies Bulk Drug Substance, Finished Dosage Forms, and Packaging Components?

What is COMPRO and which prochlorperazine suppliers matter for the drug supply chain?

COMPRO is a brand of prochlorperazine (a phenothiazine antipsychotic and antiemetic). Supplier coverage in the pharmaceutical supply chain breaks into four practical layers:

1. Bulk drug substance (API) suppliers for prochlorperazine
2. Finished dosage form (FDF) manufacturers producing COMPRO tablets/capsules and related strengths
3. Packagers (bottling/blistering, labeling, serialization, lot release support)
4. Regulatory-facing entities tied to FDA application ownership and label/strength/version-specific supply

To identify “suppliers” with litigation- and procurement-relevance, the correct starting points are:

• FDA Orange Book for the specific COMPRO strengths and dosage forms and the “Applicant/Holder” mapped to DMFs and manufacturing sites
• FDA FDF registrations and inspection history for the specific sites listed for each strength
• DMF holders for prochlorperazine API and any associated manufacturing method patents
• Authorized distributors and importers when the supply is sourced internationally

What suppliers provide prochlorperazine API (bulk drug substance) for COMPRO?

No complete, source-backed supplier list can be produced here without Orange Book and FDA database lookups for the specific COMPRO dosage forms and strengths. A prochlorperazine API market typically includes multiple DMF holders and contract manufacturers across Asia and the US, but listing names without tying them to:

• the exact COMPRO entry
• the Orange Book “Applicant”
• the DMF linkage (letter of authorization)
• and the site-level FDF/API registration would create high procurement and compliance risk.

Which companies manufacture COMPRO finished dosage forms (tablets/capsules/suspensions) for the US market?

COMPRO manufacturing is mapped in practice through:

• Orange Book entries by dosage form and strength
• the listed manufacturing sites in FDA registration systems for that product/label version
• and the relabeler/labeler structure (if COMPRO is marketed under a different labeler identity than the production site)

Without the specific Orange Book COMPRO entry content (strength-by-strength), a supplier list would be incomplete and can misdirect sourcing due to contract manufacturing swaps across years and labelers.

What is the Orange Book status of COMPRO and how does that determine supplier eligibility?

Orange Book status affects procurement through:

• whether suppliers rely on authorized generics or branded supply
• whether the product is protected by patents that restrict “same-label” generic sourcing
• whether the labeler is tied to an NDA/ANDA holder that controls manufacturing changes

A definitive status requires the Orange Book listing for COMPRO’s exact NDA/strength/dosage form. That listing is not provided in the prompt, so a correct status cannot be asserted.

Do DMFs for prochlorperazine affect which suppliers can legally provide COMPRO API?

Yes. In the US, prochlorperazine API used in an approved product typically traces through:

• an API DMF and manufacturing process approvals
• and whether the FDF manufacturer holds authorization to reference the DMF

However, a correct mapping requires DMF identifiers tied to the COMPRO Orange Book references, which is not available in the prompt.

What generic entry risks exist for COMPRO that could change sourcing suppliers?

The procurement risk is timing-based:

• If COMPRO’s branded protection barriers are no longer present for certain strengths, more contract manufacturing options open through authorized generics and ANDA supply chains.
• If patents or exclusivities remain, suppliers remain constrained to the protected product’s authorized manufacturing network.

This requires specific expiration/exclusivity data from Orange Book and Orange Book patent codes for each COMPRO strength.

How does COMPRO compare with other prochlorperazine brands in supplier chains?

Supplier chains for prochlorperazine products often converge because:

• the API is commodity-like and sourced from the same DMF-backed processes
• but FDF manufacturing can differ by labeler and strength

A supplier comparison requires listing the relevant brands’ Orange Book entries and their manufacturing sites.

When do COMPRO exclusivities or key patents expire and how does that affect supplier switching?

Exclusivity and patent expiration data drive supplier requalification:

• API qualification changes
• stability protocol updates
• ANDA/labeler transitions
• site transfers

This cannot be calculated without COMPRO’s exact NDA and patent estate data.

What does litigation or FDA enforcement history suggest about COMPRO suppliers?

Enforcement relevance is site-specific:

• warning letters, consent decrees, and inspection outcomes can force supplier replacement
• but supplier lists must be anchored to the actual FDF manufacturing sites for COMPRO

Those sites must be sourced from FDA registration and inspection records tied to the specific COMPRO product entry.

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Key Takeaways

• “Suppliers for COMPRO” is not a single entity; it is an ecosystem of API DMF holders, FDF manufacturers, and packagers mapped to the exact COMPRO Orange Book entry by strength and dosage form.
• A complete and accurate supplier list cannot be produced from the prompt alone because it requires Orange Book and FDA registration/DMF linkage for COMPRO.
• Any names not tied to the COMPRO-specific Orange Book and FDA site registrations risk being wrong for procurement and regulatory submissions.

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FAQs

1. How do I identify the API DMF holder for prochlorperazine used in COMPRO?
2. Which FDA registration sites correspond to COMPRO’s finished dosage form for each strength?
3. What Orange Book codes and patents govern COMPRO supply continuity for different strengths?
4. How do contract manufacturing site changes show up in COMPRO labeling updates?
5. What data sources best support supplier qualification for COMPRO (DMF, Orange Book, FDA registrations, inspections)?

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA.
3. U.S. Food and Drug Administration. Drug Registration and Listing System (DRLS) and facility registration databases.