Suppliers and packagers for MS CONTIN

MS CONTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Purdue Pharma Lp	MS CONTIN	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	019516	NDA	Rhodes Pharmaceuticals LLC	42858-515-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-515-01)	2017-05-15
Purdue Pharma Lp	MS CONTIN	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	019516	NDA	Rhodes Pharmaceuticals LLC	42858-631-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-631-01)	2017-05-15
Purdue Pharma Lp	MS CONTIN	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	019516	NDA	Rhodes Pharmaceuticals LLC	42858-760-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-760-01)	2017-05-15

Suppliers and packagers for MS CONTIN

Last updated: June 3, 2026

MS CONTIN (morphine sulfate) Suppliers: Who Makes It, Where Is It Produced, and What Are the Sourcing Constraints?

Executive summary: MS CONTIN (morphine sulfate extended-release) is supplied as a branded oral solid by Purdue Pharma L.P. (brand owner/marketed product) using a manufacturing and supply chain that can include multiple contract manufacturers for finished dosage form and packaging. The practical supplier set for MS CONTIN varies by strength (e.g., 15 mg, 30 mg, 60 mg), NDC, and market/lot, and it is governed by FDA labeling, current good manufacturing practice (cGMP) controls, and paragraph IV and exclusivity-driven availability. Publicly indexed “suppliers” typically map to: (1) sponsor/holder and labeler of record, (2) manufacturers listed in FDA labeling/CMC sections, and (3) wholesaler distribution network and authorized distributors for controlled substances.

Outcome: This supplier map is actionable for procurement, competitive intelligence, and litigation risk screening, but it must be NDC- and strength-specific to be operational.

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Which companies are listed as manufacturers or labelers for MS CONTIN?

Direct answer (labeler and market authorization):

• Labeler / holder of record (branded product market responsibility): Purdue Pharma L.P. (MS CONTIN is marketed under the Purdue brand).

Common “supplier” interpretations in MS CONTIN sourcing:

1. Labeler/marketer (responsible for the FDA-approved labeling and product availability).
2. Finished dosage form manufacturer(s) (cGMP site(s) that produce the ER tablets).
3. Packaging/repackaging site(s) (secondary packaging and labeling for distribution).
4. APIs (morphine sulfate API suppliers are often not identifiable from public labeling at the same granularity as finished-dose manufacturers; they may be partially disclosed in CMC summaries, DMFs, or procurement chain documentation).

Practical screening requirement: Identify the exact MS CONTIN NDC for the strength and presentation, then confirm the manufacturer and packaging sites shown for that NDC in FDA labeling/labeler listings and product databases used by procurement teams.

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What is the Orange Book status of MS CONTIN and how does it affect supplier availability?

Direct answer:

• MS CONTIN is a branded opioid ER product; Orange Book exclusivity and patent estate can impact which manufacturers can launch generics or authorized alternatives, indirectly affecting supply redundancy.

Why this matters to suppliers:

• When generic entry is limited by patents or exclusivity, the branded supply chain remains the dominant source.
• Controlled substance distribution also adds friction even where manufacturing capacity exists.

Business implication:

• If patent and exclusivity constraints delay generic competition for a specific strength/NDC, the “supplier universe” shrinks to the branded manufacturers and any licensed production/authorized equivalents.

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Which MS CONTIN strengths have different suppliers or manufacturing sites?

Direct answer:

• Supplier mapping can differ by strength because:
  • tablet compression tooling and film/coating runs can be strength-specific,
  • packaging line qualification varies,
  • inventory is allocated by lot and NDC, and
  • FDA inspection outcomes can force site substitution.

Operational consequence:

• Procurement teams should not assume one manufacturer covers all strengths.
• Regulatory affairs and supply chain should align manufacturer confirmation by strength and NDC before vendor onboarding.

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Which APIs supply morphine sulfate ER for MS CONTIN?

Direct answer:

• MS CONTIN uses morphine sulfate as the active ingredient; the API supplier set is typically broader than the finished-dose manufacturer set.
• Public procurement visibility into API sources is usually limited compared with finished-dose manufacturer visibility.

Supplier categories that matter:

1. Morphine sulfate API production and release testing (including impurity profiles).
2. Finished-dose blending and extrusion/compression controls for extended-release performance.
3. ER matrix or coating systems that control morphine release rate.
4. Analytical method validation across lots and manufacturing sites.

Key sourcing constraint:

• For extended-release morphine tablets, dose uniformity and dissolution/ release specifications control which manufacturing sites can qualify as reliable suppliers.

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How many finished-dose manufacturers make MS CONTIN tablets?

Direct answer:

• The number varies by strength and NDC and can change due to:
  • cGMP remediation,
  • new line qualification,
  • capacity constraints,
  • packaging line changes,
  • and supply chain reallocation.

Supplier intelligence approach used in practice:

• Map each strength’s NDC to:
  • finished-dose manufacturing sites,
  • packaging sites,
  • and labeler/marketer.

Outcome:

• The “supplier count” is best expressed as an NDC-to-site mapping table, not a single number across the product family.

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What contract manufacturing networks supply MS CONTIN packaging and distribution?

Direct answer:

• MS CONTIN’s packaging includes bottle labeling, blister packaging (if applicable), and unit labeling tied to NDCs and lot traceability.
• Packaging is often executed by packagers/secondary manufacturers that are separate from the tablet compression site.

Controlled-substance distribution constraint:

• Distribution requires registered DEA and state licensing, which means the effective “supplier to dispenser” channel is restricted to authorized distributors and controlled substance logistics networks.

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What generic entry risks exist for MS CONTIN and how do they change supplier dynamics?

Direct answer:

• MS CONTIN’s ER morphine sulfate format has high regulatory scrutiny, and supplier dynamics shift when:
  • a generic or authorized generic is approved,
  • patent litigation is stayed or settled,
  • or exclusivity blocks entry for specific strengths.

Why this affects suppliers:

• Generic approvals can:
  • increase the number of sourcing options for wholesalers,
  • force branded inventory rebalancing,
  • and reallocate manufacturer capacity.
• Conversely, patent barriers keep the branded product dominant.

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Does MS CONTIN have biosimilar risk?

Direct answer:

• No. MS CONTIN is a small-molecule opioid ER product (morphine sulfate), not a biologic, so it does not face biosimilar pathways.

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MS CONTIN patent litigation and settlements: do they impact who can supply it?

Direct answer:

• Patent and exclusivity status affects whether other manufacturers can market an approved generic/authorized product, which changes supply availability.

Supplier impact mechanism:

• If multiple Paragraph IV or ANDA actions are resolved with settlements or injunctions, generic launch timing can be delayed, maintaining a narrower branded supply footprint for longer.

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FDA status questions that change sourcing: ANDA approvals, supplements, and labeling changes

Direct answer:

• FDA-approved labeling and manufacturing changes can lead to:
  • NDC churn,
  • manufacturer substitution on the label,
  • and lot release reallocations among cGMP sites.

Supplier implication:

• Sourcing should be tied to the exact approved manufacturing site for each NDC and strength.

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Key sourcing table template for MS CONTIN (strength-by-NDC supplier mapping)

Use this structure for internal procurement and regulatory verification:

MS CONTIN strength	NDC (11/10-digit as used internally)	Labeler/marketer	Finished-dose manufacturer site	Packaging site	DEA/distribution channel notes
15 mg ER	(fill from NDC)	Purdue Pharma L.P.	(from FDA labeler/manufacturer listing)	(from FDA listing)	Authorized controlled-substance distributors only
30 mg ER	(fill)	Purdue Pharma L.P.	(fill)	(fill)	Lot traceability required
60 mg ER	(fill)	Purdue Pharma L.P.	(fill)	(fill)	Strength-specific inventory control

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Key Takeaways

• MS CONTIN’s “supplier” landscape is governed by brand label responsibility (Purdue Pharma L.P.) plus NDC- and strength-specific finished-dose and packaging manufacturing sites.
• For procurement and compliance, suppliers should be validated at the NDC-strength-manufacturer level, not at the brand level.
• Patent and exclusivity status affects when additional manufacturers can supply approved equivalents, shifting supply availability over time.

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FAQs

1. How do I identify the manufacturing site for the exact MS CONTIN NDC and strength?
2. Can MS CONTIN suppliers change after FDA labeling or manufacturing supplements?
3. What controlled-substance distribution constraints limit MS CONTIN sourcing for pharmacies and hospitals?
4. What CMC factors determine whether a contract manufacturer can produce morphine sulfate ER tablets?
5. How does generic competition for morphine sulfate ER alter MS CONTIN supply risk and vendor concentration?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. SPL (Structured Product Labeling) / Product Data. https://www.fda.gov/industry/structured-product-labeling-spl
4. DEA. Diversion Control Program information and registration requirements. https://www.deadiversion.usdoj.gov/