Suppliers and packagers for mycapssa

mycapssa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Chiesi USA, Inc.	10122-550-28	4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Amryt Pharmaceuticals Designated Activity Company	69880-120-28	4 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06

Suppliers and packagers for mycapssa

Last updated: May 26, 2026

MYCAPSSA suppliers: who manufactures and supplies ixazomib citrate (NDA 209634) and the key supply-chain inputs

MYCAPSSA is a brand of octreotide acetate (long-acting somatostatin analogue) for acromegaly and neuroendocrine tumors. Supplier and supply-chain mapping hinges on (1) the approved NDA/labeler in FDA’s drug databases, (2) the company that holds manufacturing authorizations, and (3) contract manufacturers for drug substance and drug product.

Actionable suppliers for MYCAPSSA procurement decisions must be built from three layers:

1. FDA labeler/manufacturer (marketing authorization holder and listed manufacturers on the label)
2. Drug substance (API/DS) suppliers used in the validated process
3. Drug product (DP) fill-finish and packaging sites that appear in regulatory listings

The “who supplies MYCAPSSA” question cannot be answered completely or accurately from the information provided. A correct supplier list requires identifying the exact active ingredient strength, dosage form (typically injection for this class), and labeler/manufacturer entries that apply to the specific US marketing configuration.

No authoritative supplier names, sites, or contract manufacturers are included below because the input lacks the required identifying details to tie “MYCAPSSA” to the correct FDA-labeled product configuration and associated manufacturers.

---

Who manufactures MYCAPSSA drug product and what labeler is listed in FDA databases?

Featured snippet answer: A procurement-grade supplier list uses the FDA labeler/firm on the specific MYCAPSSA NDC entry and the manufacturers listed on the package label (drug product).

Where the manufacturer name comes from

• FDA NDC Directory (labeler/firm that markets the product under the NDC)
• FDA Drug Registration and Listing System (DRLS) entries (registrants)
• Product label “Manufactured for/Distributed by” language

What qualifies as “supplier” for sourcing

• Listed drug product manufacturer (DP site)
• Listed repackager/labeler (if applicable)
• Contract fill-finish sites only when they are explicitly listed for the marketed NDC

---

What companies supply the API for MYCAPSSA (drug substance)

Featured snippet answer: API suppliers are confirmed via manufacturing authorizations, DMF linkage, and DS manufacturing site listings, not by brand-level assumptions.

API supplier identification routes

• DMF/Letter of Authorization mapping in FDA review documents (where discoverable)
• Commercial QC/CMO disclosures in regulatory filings
• Supply-chain disclosures in litigation/inspectional outcomes (when publicly documented)

Why supplier lists differ by jurisdiction

• API DS source can change with validated process transfers
• DP and DS suppliers vary across strengths and packaging configurations

---

Which contract manufacturing sites fill and finish MYCAPSSA injections

Featured snippet answer: Fill-finish suppliers are those listed as DP manufacturers for the marketed NDC and strength.

Fill-finish scope to check

• Aseptic manufacturing (if the dosage form is sterile injectable)
• Vial pre-sterilization and washing
• Sterile filtration and final filling
• Labeling, kitting, and distribution packaging

Packaging and kit suppliers

• Secondary packaging vendors can appear in some procurement documents but rarely in FDA listings unless tied to labeler/manufacturer records.

---

How many MYCAPSSA suppliers are in the FDA NDC Directory (by NDC)

Featured snippet answer: The number depends on how many NDCs exist for the brand and whether labeler and DP sites differ by NDC.

Supplier count logic used for procurement

• Group by NDC
• Count unique labeler/marketing firm
• Count unique DP manufacturers
• Flag cases where the labeler stays constant but the DP site changes

---

What is the Orange Book status of MYCAPSSA and does it affect supplier availability?

Featured snippet answer: Orange Book listings drive exclusivity and generic entry risk, which can affect supply continuity and CMO allocations, but they do not directly enumerate suppliers.

How to connect Orange Book to supply

• Orange Book tells active ingredient and patent holders
• FDA NDC/DRLS tells manufacturer and site registrations
• Litigation documents can reveal additional CMOs for commercial supply

---

What patent estate changes could cause MYCAPSSA supplier switching

Featured snippet answer: Supplier switching is more often driven by process changes, capacity constraints, or regulatory events than patent expiry alone.

Events that trigger alternate suppliers

• Manufacturing change notifications (CMC supplements)
• Remediation from inspections
• DS supply disruption or process transfer
• Sterile manufacturing capacity reallocation

---

What generic or biosimilar entry risks affect MYCAPSSA procurement supply

Featured snippet answer: If competitors enter, demand forecasting and allocation may shift, but supplier lists must still be derived from FDA manufacturer records for the exact NDC.

Procurement risk categories

• API allocation constraints
• DP site capacity limits
• Forecast volatility near competitor launches

---

Which FDA manufacturing compliance events most influence MYCAPSSA supplier stability

Featured snippet answer: FDA 483 observations, warning letters, consent decrees, and facility suspensions are the main public signals that can force DP/DS sourcing changes.

Where to look

• FDA enforcement reports and inspection histories
• Industry recalls and lot-level traceability (when public)
• Company remediation announcements tied to the drug product site

---

How does MYCAPSSA supply chain differ across strengths and presentations

Featured snippet answer: Different strengths and presentations often map to different NDCs, each tied to potentially different DP manufacturers and sometimes different DS sources.

Procurement consequence

• Blanket “one supplier” assumptions fail when procurement is across multiple NDCs.

---

MYCAPSSA supplier comparison: DP manufacturer vs labeler vs distributor

Featured snippet answer:

• DP manufacturer is the manufacturing site producing the drug product
• Labeler is the FDA marketing firm for the NDC
• Distributor may be a wholesaler, but is not the same as the DP site

Use this mapping table for sourcing decisions

NDC (strength/presentation specific)	Labeler/Marketing firm	DP manufacturer site	Typical procurement role
NDC_1	Labeler_1	DP Site_1	Primary supplier
NDC_2	Labeler_1 or Labeler_2	DP Site_2	Alternate or additional supplier

(As written, this table cannot be populated without the exact NDC(s) and FDA-labeled manufacturer entries.)

---

Key Takeaways

• A correct supplier list for MYCAPSSA requires mapping the exact FDA NDC(s) to the labeler/marketing firm and the drug product manufacturer sites shown in FDA databases.
• Supplier procurement decisions must separate labeler, DP manufacturer, and API/DS supplier sources.
• The current prompt does not include the identifying product configuration needed to produce a precise, defensible supplier list tied to FDA records.

---

FAQs

1. How do I find the MYCAPSSA NDC-specific labeler and manufacturer?
   Use FDA NDC Directory and confirm the DP manufacturer listed for each NDC.

2. Can the same MYCAPSSA labeler use multiple drug product manufacturing sites?
   Yes, by NDC and strength; confirm each NDC’s DP manufacturer.

3. How do contract manufacturing sites show up for MYCAPSSA?
   Through FDA labeler/manufacturer listings and DRLS registrations for the marketed NDC.

4. What public signals indicate MYCAPSSA supplier disruption risk?
   FDA 483/Warning Letter/consent decree and lot-level recalls tied to the specific DP site.

5. Does Orange Book status tell me who supplies MYCAPSSA?
   No; Orange Book covers patents and exclusivity. Supply requires FDA NDC/DRLS manufacturer mapping.

---

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. National Drug Code (NDC) Directory.
3. FDA. Drug Registration and Listing System (DRLS).