Suppliers and packagers for GENERLAC

GENERLAC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Rx	GENERLAC	lactulose	SOLUTION;ORAL, RECTAL	074603	ANDA	Chartwell RX, LLC	62135-892-47	473 mL in 1 BOTTLE (62135-892-47)	1996-10-31
Chartwell Rx	GENERLAC	lactulose	SOLUTION;ORAL, RECTAL	074603	ANDA	Chartwell RX, LLC	62135-892-94	946 mL in 1 BOTTLE (62135-892-94)	1996-10-31

Suppliers and packagers for GENERLAC

Last updated: June 1, 2026

Suppliers for Generlac (Lactulose) Pharmaceutical Drug: Key Manufacturers, Sources, and Supply-Chain Exposure

Generlac is a lactulose oral solution product. The supplier universe is primarily US-based contract manufacturers (oral liquid dosage forms) and vertically integrated brand and generic companies that hold FDA product approvals and supply through wholesalers and distributors. The practical “suppliers” for Generlac supply are (1) the FDA-approved marketing authorization holders for each Generlac strength/dosage form and (2) the contract manufacturing sites that produce the oral solution under current Good Manufacturing Practice.

Because “Generlac” naming and packaging/strength can vary by market and over time, supplier lists must be tied to a specific FDA-labeled product (strength and dosage form) and its corresponding application/Orange Book record. Without the exact Generlac strength/dosage form and the associated FDA application (NDA/ANDA/BLA and corresponding Orange Book listing), a complete and accurate supplier map cannot be produced.

What companies supply Generlac (lactulose) oral solution in the US?

Answer: Supply is split between marketing authorization holders (brand/generic “labeler” on the FDA product listing) and the manufacturing contractors that make lactulose oral solution at approved sites.

How to identify the true supplier for Generlac

1. FDA “Labeler” and application holder (NDA/ANDA): identifies the company responsible for the product’s FDA submission and release obligations.
2. Orange Book listing: links to the relevant application and patent/exclusivity coverage for that exact dosage form/strength.
3. NDC-to-manufacturer mapping (and labeler attribution): supports identifying the labeled supplier that ships into distribution channels.
4. cGMP manufacturing site (from FDA facility records and inspection outcomes): identifies the actual contract manufacturer.

Where supplier data is typically sourced

• FDA NDC Directory for labeler/packager attribution.
• Orange Book for the application tied to the specific dosage form.
• Drug establishment registration and listing (DE/DRLM) for registered manufacturing sites.
• FDA inspection databases for manufacturing site compliance history.

Which contract manufacturing organizations produce lactulose oral solution for Generlac?

Answer: Lactulose oral solution is commonly produced by CMO/CDMO networks specialized in oral liquids (viscous syrups/solutions), including lines that support high-viscosity mixing, sterile-free filling, and bottle/10 mL/15 mL/other closure systems.

Typical CMO/CDMO capability requirements for lactulose

• High-shear mixing capability for viscous lactulose solutions
• In-process controls for viscosity, density, and assay
• Filling/packaging lines appropriate for oral solution packaging
• Validation for container-closure integrity for long shelf life

What makes lactulose supply chain “supplier sensitive”

• Volatility in bulk lactulose feedstock availability and pricing
• Need for strict control of microbial limits in oral solutions
• Dependence on filling line scheduling across oral solid and oral liquid portfolios

What is the Orange Book status of Generlac lactulose oral solution?

Answer: Orange Book status is determined per strength and dosage form and varies by application. A supplier-and-timing view requires a specific Orange Book listing for the Generlac-labeled product.

How Orange Book ties into supplier selection

• If multiple applications exist for the same marketed NDC/strength, supplier competition generally increases.
• Patent and exclusivity status can influence which labelers can legally launch or switch supply sources.

When does exclusivity expire for Generlac lactulose oral solution?

Answer: Exclusivity is application-specific and product-strength-specific.

Typical exclusivity drivers for oral small molecules

• NDA exclusivity (historically uncommon for old-market lactulose)
• Patent protection (composition, formulation, method-of-use, or process)
• Patent expiration calendar and any Orange Book-listed “listed patents”

How many suppliers can make Generlac (lactulose) oral solution without infringing patents?

Answer: The count depends on:

• Whether the relevant application is fully “off-patent”
• Whether there are still Orange Book listed formulation/process patents
• Whether any new patents block approval or launch for specific changes (strength, stability-improved formulation, container closure)

What limits generic/authorized supply for lactulose oral solution

• Remaining listed patents for the specific dosage form
• Formulation-level changes (stabilizers, viscosity targets, shelf-life improvements)
• Process patents affecting manufacturing method

What generic entry risks exist for Generlac (lactulose) oral solution?

Answer: Entry risks are primarily legal (Orange Book patents) and operational (oral solution manufacturing capacity), not biotech-style biosimilarity.

Paragraph IV risks (if any)

• If Orange Book patents remain listed, generics seeking approval may file Paragraph IV certifications, creating litigation and potential “carve-out” launch delays.

Which companies are challenging Generlac (lactulose) patents via Paragraph IV?

Answer: A credible list requires the specific Orange Book listing and the relevant ANDA applicants with their Paragraph IV certifications. Without the exact Orange Book record tied to the marketed Generlac strength/dosage form, no accurate challengers can be stated.

How does Generlac compare with other lactulose brands and generics on supplier sourcing?

Answer: Supplier sourcing is usually comparable across lactulose brands: multiple labelers can source from overlapping CMO networks producing lactulose oral solutions, with differentiation mainly in:

• NDC/packaging format
• Shelf life and stability specifications
• Labeling and manufacturing release testing

Why brand-to-generic supply can look similar

• Lactulose is a mature small molecule.
• Oral solution manufacturing is commoditized in many CMO portfolios.
• The practical supplier is defined by current FDA-approved manufacturing and labeler attribution.

What manufacturers are registered with FDA to make lactulose oral solution?

Answer: FDA registration covers establishments, not “brands.” For supplier mapping, the manufacturing sites registered for lactulose oral solution must be matched to the labeled product’s application and approved manufacturing instructions.

Supplier mapping workflow used for oral liquids

1. Identify the Generlac strength/dosage form and NDC(s)
2. Map NDC to labeler and application
3. Pull the application’s approved manufacturing sites
4. Confirm each site’s FDA establishment registration for that dosage form
5. Cross-check recent inspection outcomes for continuity risk

Key Takeaways

• Generlac supply is defined by labeler/application holder and the FDA-approved manufacturing sites that produce the lactulose oral solution.
• A full supplier list cannot be accurate without a specific Generlac strength/dosage form and its FDA application/Orange Book listing.
• Lactulose oral solution supplier risk is typically operational (oral liquid capacity, bulk availability, packaging line constraints) and legal (Orange Book-listed patents tied to that specific dosage form).

FAQs

1. How do I identify the actual manufacturer behind a Generlac NDC?
   Use the NDC Directory to map to the labeler, then cross-reference the linked application’s approved manufacturing sites in FDA records.

2. Do contract manufacturers make multiple lactulose brands using the same facility?
   Yes, oral solution CMOs often produce for multiple labelers, with differences mainly in formulation specs and packaging.

3. Is Generlac supply limited by FDA manufacturing approvals?
   Supplier availability depends on whether alternative manufacturing sites are approved under the applicable application.

4. What causes sudden supply disruptions for lactulose oral solutions?
   Filling line availability, bulk lactulose supply constraints, and site-specific compliance actions can drive disruptions.

5. How can patent status affect who can supply Generlac?
   Remaining Orange Book patents for the specific dosage form can restrict new entrants or delay launches tied to application certifications.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. NDC Directory.
3. U.S. Food and Drug Administration. Drug Establishment Registration and Drug Listing (DE/DRLM).