Suppliers and packagers for LINCOCIN

LINCOCIN

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	LINCOCIN	lincomycin hydrochloride	INJECTABLE;INJECTION	050317	NDA	Pharmacia & Upjohn Company LLC	0009-0104-04	1 VIAL in 1 CARTON (0009-0104-04) / 2 mL in 1 VIAL	2023-08-18
Pfizer	LINCOCIN	lincomycin hydrochloride	INJECTABLE;INJECTION	050317	NDA	Pharmacia & Upjohn Company LLC	0009-0107-04	1 VIAL in 1 CARTON (0009-0107-04) / 10 mL in 1 VIAL	2023-04-18

Lincocin suppliers: who manufactures lincomycin (active ingredient and finished drug) and how to map the supply chain

Last updated: May 26, 2026

Executive summary Lincocin is the brand name for lincomycin (lincomycin hydrochloride). The practical supplier set splits into (1) API manufacturers of lincomycin HCl and (2) finished-dose manufacturers that make injectable or oral products marketed as Lincocin or authorized generics. A complete, defensible “supplier list” cannot be produced from the information provided.

H1: Lincocin suppliers for lincomycin hydrochloride API and finished-dose products

Which companies supply lincocin (lincomycin) in the U.S. market?

Featured-snippet answer: The supplier roster is determined by Orange Book-listed manufacturers for each NDC strength/form and by contract manufacturing for finished dosage forms, with separate identification for API supplied to those formulators.

How to identify finished-dose suppliers (NDC level)

Key inputs used in supply-chain mapping:

• FDA Orange Book listing for lincomycin hydrochloride products (brand and generics) by dosage form and strength
• NDC labeler/manufacturer shown on FDA product databases and commercial packaging
• cGMP facility ownership (manufacturer of record vs labeler vs holder)

Common finished-dose format mapping for lincomycin

Supply mapping must be done separately for:

• Oral capsules/tablets (if marketed for lincomycin)
• Injectables (if marketed for lincomycin)
• Any reformulations or alternate salt forms (rare for lincomycin brands, but must be checked per NDC)

What patents protect lincomycin (Lincocin) suppliers and block generic entry?

Featured-snippet answer: Lincomycin is an older antibiotic; patent coverage, if any, typically sits in formulation, method-of-use, or manufacturing/process rather than broad compound patents, and supplier ability to market depends on Orange Book status for each specific listed product.

How patent status affects supplier participation

• If a listed patent remains, FDA applicants may need authorization, licensing, or risk Paragraph IV litigation.
• If no listed patents remain, multiple suppliers can compete on formulation and manufacturing cost.

How to check patent blocks per dosage form

Patent estate mapping is done per:

• Active ingredient: lincomycin hydrochloride
• Dosage form: injectable vs oral
• Strength: each listed NDA application is mapped separately

What API suppliers make lincomycin hydrochloride?

Featured-snippet answer: API suppliers are not reliably inferable from brand naming alone; a supplier list requires API shipment attribution to cGMP plants via:

• FDA DMF referencing (where available by product and applicant)
• supplier/manufacturer-of-record shown in regulatory submissions
• third-party manufacturing registries tied to the drug substance

API substance: lincomycin hydrochloride

Supply-chain mapping must separate:

• DMF holders for lincomycin HCl
• API manufacturers that synthesize and crystallize the salt form
• re-packers vs actual API manufacturers

API form controls

Even when API suppliers are “known,” onboarding depends on:

• particle size/specs
• polymorph or crystallization controls for lincomycin HCl
• residual solvents and related impurity profiles

Which generics compete with Lincocin, and who makes them?

Featured-snippet answer: The generics landscape for lincomycin is identified by Orange Book competitors for each relevant NDC strength/form.

How supplier churn changes the competitive picture

Older antibiotics commonly see:

• consolidation of manufacturing capacity
• discontinuations for low-demand strengths
• periodic relabeling or contract-manufactured batches

Manufacturing/IP barriers that influence who can supply

Barriers include:

• regulatory history for inspections
• ability to meet sterility/endotoxin controls for injectables
• validated impurity specifications for API

What is the FDA Orange Book status of lincomycin (Lincocin) products?

Featured-snippet answer: Orange Book status is determined per NDA and by listed patents (compound, formulation, method of use) and whether any are still “in force.”

Orange Book fields that drive supplier licensing decisions

Supply agreements typically reference:

• patent numbers and expiration dates
• exclusivity codes and end dates
• dosage form–specific exclusivity triggers

How do Paragraph IV challenges affect lincocin/lincomycin supplier availability?

Featured-snippet answer: Paragraph IV activity changes time-to-market for competing suppliers and may trigger:

• 30-month stay (if applicable)
• settlement-based entry triggers

Where to look in litigation to map supplier risk

Mapping uses:

• ANDA case filings (federal district courts)
• court dockets and settlement press releases
• settlement terms tying entry to specific dates

What commercial channels supply lincocin (wholesalers vs direct-to-hospital)?

Featured-snippet answer: In antibiotic supply, the practical “supplier” is often the wholesale distributor network rather than the original NDA/API maker.

Typical distribution structure

• API producer → finished-dose manufacturer → wholesaler/distributor → hospital/pharmacy
• For shortages, FDA and distributors may route product from alternative labelers or contract manufacturers

Shortage risk and allocation

When demand spikes or supply interruptions occur, allocation usually follows:

• primary wholesalers’ inventory allocation policies
• alternative NDC sourcing
• emergency importation (if allowed)

How does lincocin supply compare with other lincosamides like clindamycin?

Featured-snippet answer: Both belong to the lincosamide class; supplier landscape differs because clindamycin has a much larger generic footprint and broader market demand.

Supplier breadth impact

• Broader generic competition typically means more redundant manufacturing capacity.
• Narrower lincomycin demand can reduce the number of viable suppliers.

Key supply-chain mapping template for lincomycin (Lincocin)

Use this framework to produce an auditable supplier roster:

1. Select target markets: US first, then any specific countries if relevant
2. Identify NDCs for each strength and dosage form
3. Pull Orange Book entries for each NDC
4. Record labeler/manufacturer-of-record from FDA label and distribution data
5. Map API manufacturers via DMF references used by each finished-dose applicant
6. Flag facility constraints: sterile manufacturing for injectables, API release specs, recent inspections

Key takeaways

• “Lincocin suppliers” must be defined at NDC and product-configuration level to identify finished-dose manufacturers.
• API suppliers for lincomycin hydrochloride require DMF and regulatory traceability, not brand-level inference.
• Patent and exclusivity status is a dosage-form-specific gating factor for who can supply the finished product through FDA pathways.

FAQs

1. How can I find the manufacturer-of-record for a specific Lincocin NDC?
2. Do lincomycin injectable products have different supplier constraints than oral formulations?
3. Which regulator databases best map lincomycin DMF holders to finished-dose applicants?
4. What shortage history would indicate reduced supplier redundancy for lincomycin?
5. How do settlement agreements in generic lincomycin litigation translate into supplier entry dates?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. (Accessed via FDA Orange Book database).