Suppliers and packagers for miochol-e

miochol-e

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	MIOCHOL-E	acetylcholine chloride	FOR SOLUTION;OPHTHALMIC	020213	NDA	Bausch & Lomb Incorporated	24208-539-20	1 KIT in 1 BLISTER PACK (24208-539-20) * 2 mL in 1 VIAL * 2 mL in 1 AMPULE	1993-09-22

Suppliers and packagers for miochol-e

Last updated: June 1, 2026

Who Supplies Miochol-E (carbachol) for Ophthalmic Use: Manufacturers, Labelers, and Distribution

Executive summary: Miochol-E (carbachol chloride ophthalmic solution) is supplied through a small set of known labeler/manufacturer channels tied to the drug’s NDA/ANDA ecosystem. The practical supplier list for procurement depends on whether you source through the FDA-registered labeler on the bottle (NDC label), the distributor/wholesaler on your GPO contract, or a specific sterile fill-finish/packaging site. This matters because Miochol-E is dispensed as a regulated, sterile ophthalmic product and can change by NDC even when the active ingredient remains the same.

Miochol-E active ingredient: carbachol chloride (ophthalmic solution).

What you can buy (commercially): Miochol-E is sold as a prescription ophthalmic drug. Supplier identification is best anchored to the NDC labeler and the FDA “applicant/labeler” listed for that specific NDC strength and package configuration, then traced to the manufacturing site if you need contract sterilization or packaging verification.

Who manufactures Miochol-E (carbachol) and who is the FDA labeler for each NDC?

Direct answer: The “supplier” most relevant to procurement is the NDC labeler shown on the product package and in FDA drug listing files for the specific carbachol chloride ophthalmic solution strength and package size.

How Miochol-E supplier status is determined (NDC labeler vs. manufacturer)

• NDC labeler: the entity responsible for marketing under that NDC.
• Manufacturer (site): the registered facility that performs drug substance to drug product steps (or fill-finish) under the labeler’s application.
• Wholesaler/distributor: GPO or independent channel that physically ships the product, which may differ from the FDA labeler.

Supplier mapping approach

A complete supplier list for Miochol-E must be built by NDC:

1. Pull the FDA “Drug Listing” labeler for each Miochol-E NDC.
2. Pull the registered manufacturing sites from the same listing or from the corresponding application supplements.
3. Cross-check packaging and lot release realities via the NDC labeler’s reported manufacturing responsibilities.

What supply chain entities distribute Miochol-E through US wholesalers and GPOs?

Direct answer: Distribution is typically handled by major US pharmaceutical wholesalers and by GPO-contracted distributors, but the identities vary by NDC and by contract. The supplier you pay through procurement is usually the wholesaler on your contract, while the responsible legal supplier remains the NDC labeler.

Common US distribution channels

• National wholesalers (e.g., broad coverage for prescription distribution)
• Specialty ophthalmic channels where applicable
• Hospital pharmacy and wholesaler-direct programs where contracts differ by region

Which companies are responsible for fill-finish and sterile packaging of Miochol-E?

Direct answer: For sterile ophthalmic products like Miochol-E, the manufacturing responsibilities usually split across:

• sterile drug product manufacturing site(s) under CGMP
• packaging and labeling site(s), sometimes integrated with manufacturing, sometimes outsourced

What to look for in manufacturing disclosures

• Sterile manufacturing category (aseptic processing vs terminal sterilization, as applicable to the product)
• Fill-finish site registration
• Packaging configuration mapping to the correct NDC

What patents protect Miochol-E suppliers, and can manufacturing be designed around?

Direct answer: Patent/market exclusivity can affect whether alternate manufacturers can supply the same protected version, but supply decisions for Miochol-E are also driven by whether an alternative can obtain the correct approvals for the exact NDC, strength, and dosage form.

Why patent estate matters for supply

• If the formulation, use, or manufacturing method is protected, entrants can be blocked unless they design around or license.
• If the product is off-patent, supply can still be constrained by:
  • sterile manufacturing capacity
  • regulatory approval history for equivalent NDCs
  • quality system readiness for ophthalmic sterile solutions

What generic or alternate carbachol ophthalmic products can substitute for Miochol-E and how does that impact suppliers?

Direct answer: Supplier availability can shift if therapeutically substitutable products exist (same active ingredient and similar clinical positioning) and are preferred by procurement formularies. Substitution can reduce risk concentration on a single labeler/manufacturer channel.

Procurement impact

• If your contract allows therapeutic substitution, you can diversify supplier risk across:
  • alternative carbachol ophthalmics
  • different strengths or package sizes
• If your contract specifies “Miochol-E only,” you concentrate purchasing on the specific labeler NDC you buy.

What Orange Book status affects who can supply Miochol-E?

Direct answer: Orange Book status is relevant to whether there is exclusivity that bars generic substitution. For supply planning, the key is the combination of:

• Orange Book-listed patents (if applicable)
• 505(b)(1)/505(j) pathway history (if applicable)
• exclusivity end dates

Supplier risk implications

• If patents/exclusivities are still in force, supply is typically limited to the original NDA labeler and authorized supply chain partners.
• If off-patent, you may see more labelers and more NDC options even if the active ingredient stays the same.

Key Takeaways

• “Supplier” for Miochol-E is defined operationally by the NDC labeler and contract distributor, not just by the active ingredient.
• A complete supplier roster requires NDC-level mapping to FDA labeler and registered manufacturing sites.
• Manufacturing and packaging constraints for sterile ophthalmic solutions can keep the supplier base narrower than for non-sterile drugs.
• Patent and Orange Book status (where listed) can materially affect whether alternative manufacturers can legally supply an equivalent product.

FAQs

1. How do I identify the correct supplier for Miochol-E for procurement when multiple NDCs exist?
2. Can I substitute another carbachol ophthalmic product for Miochol-E without changing supply chain risk?
3. How does sterile fill-finish capacity affect Miochol-E supplier continuity?
4. What does the FDA labeler on the NDC tell me about the actual responsible supplier for Miochol-E?
5. What regulatory status (Orange Book and exclusivity) most affects who can supply Miochol-E generics or equivalents?

References

1. FDA. Drug Listing Files (NDC labeler and listing data).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.