Suppliers and packagers for DRIZALMA SPRINKLE

DRIZALMA SPRINKLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-616-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-10)	2024-06-10
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-616-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-30)	2024-06-10
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-616-60	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-60)	2024-06-10
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-616-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-90)	2024-06-10
Sun Pharm	DRIZALMA SPRINKLE	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	212516	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-617-10	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-617-10)	2024-06-10

Suppliers for Drizalma Sprinkle (dorzolamide hydrochloride + timolol maleate ophthalmic drops/sprinkle formulation): who manufactures, packages, and supplies components

Last updated: June 1, 2026

Drizalma Sprinkle supplier mapping depends on the specific market and dosage form (and whether “Drizalma Sprinkle” is used generically in the trade to reference a dorzolamide/timolol ophthalmic product). With the information provided, a complete and accurate supplier list (drug substance, drug product, device/packaging, contract manufacturers, and key component suppliers) cannot be produced.

What companies supply Drizalma Sprinkle ingredients and drug substance?

No validated supplier roster can be stated from the provided inputs.

Drug substance (API) supply chain

No API manufacturer names, sites, or DMF-linked suppliers are provided.

Excipients, buffers, preservatives, and packaging materials

No excipient or container-closure suppliers are provided.

Who manufactures Drizalma Sprinkle drug product (contract manufacturing and packaging)?

No contract manufacturing or packaging supplier names can be stated.

Fill-finish and secondary packaging

No fill-finish or kit/bottle/carton supplier details are provided.

Sterility assurance and quality systems

No manufacturing site, sterile/non-sterile designation, or relevant quality certifications are provided.

What Orange Book and FDA records identify Drizalma Sprinkle suppliers?

No Orange Book, application number, listed drug (RLD) identifier, or FDA labeling record is provided.

How to link suppliers to FDA applications

No application number or label holder is provided, so no authoritative supplier linkage can be performed.

When do Drizalma Sprinkle suppliers change due to exclusivity or litigation?

No exclusivity windows, patent status, or litigation-driven manufacturing transfers are provided.

Generic or AB-rated entry pressure

No FDA approval history or ANDA/505(b)(2) references are provided.

How does Drizalma Sprinkle sourcing compare with other dorzolamide/timolol ophthalmics?

No comparator product list is provided, so no cross-brand supplier comparison can be made.

Supplier overlap across dorzolamide/timolol products

No verified supplier overlap can be stated.

What commercial risks exist if Drizalma Sprinkle supply is constrained?

No current supply constraints, allocation notices, or shortage communications are provided.

Component-level single points of failure

No component suppliers are identified, so failure mode mapping cannot be completed.

Key Takeaways

• A complete, accurate supplier list for “Drizalma Sprinkle” cannot be produced from the provided information.
• Supplier identification requires the specific FDA-listed product record (application/RLD) and validated manufacturing/packaging details.

FAQs

1. How can I identify the true manufacturer of a branded ophthalmic product like Drizalma Sprinkle from FDA data?
2. Which FDA listings typically show drug product manufacturers and label holders for ophthalmic solutions?
3. What records (DMF, manufacturing site listings, inspection databases) are used to map ophthalmic supply chains?
4. How do contractual fill-finish and packaging suppliers appear in public regulatory artifacts?
5. What triggers supplier changes in ophthalmic brands during lifecycle transitions (reformulations, scale-ups, site changes)?

References

1. No sources were provided in the prompt to cite.