Suppliers and packagers for PULMICORT RESPULES

PULMICORT RESPULES

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929	NDA	AstraZeneca Pharmaceuticals LP	0186-1988-04	6 POUCH in 1 CARTON (0186-1988-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE	2000-09-08
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929	NDA	AstraZeneca Pharmaceuticals LP	0186-1989-04	6 POUCH in 1 CARTON (0186-1989-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE	2000-09-08
Astrazeneca	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929	NDA	AstraZeneca Pharmaceuticals LP	0186-1990-04	6 POUCH in 1 CARTON (0186-1990-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE	2007-09-17

Suppliers and packagers for PULMICORT RESPULES

Last updated: June 13, 2026

Suppliers for Pulmicort Respules (Budesonide Inhalation Suspension): Who Makes It, Who Controls Supply, and What Inputs Are Constrained

Pulmicort Respules is budesonide inhalation suspension supplied for U.S. respiratory care markets under the AstraZeneca trade name (historically marketed by AstraZeneca Pharmaceuticals). Supply chain roles split into: (1) drug substance and finished-dose manufacturing, (2) contract manufacturing and packaging for suspension and single-dose units, (3) excipient sourcing for aqueous suspensions, and (4) primary packaging film and unit-dose components that often drive lead-time.

The key supplier set for market access is determined by FDA labeling and current cGMP manufacturing/label-claim sites, and by Orange Book listed manufacturers for the relevant NDCs. Without NDC-level, strength-level, and labeler/packager specificity, a complete supplier map cannot be produced from reliable public records.

Who are the contract manufacturers and finished-dose suppliers for Pulmicort Respules?

Pulmicort Respules is a budesonide suspension in unit-dose form. The supplier question resolves at three tiers:

1) Finished-dose manufacturing and aseptic/non-aseptic suspension processing

For inhalation suspensions, the dominant supplier archetypes are contract manufacturing organizations (CMOs) that handle:

• budesonide blending into suspension-grade aqueous systems
• high-shear or controlled dispersion milling/processing for uniformity
• container fill and sealing for single-dose respules

2) Unit-dose packaging and sealing suppliers

Respules are defined by their container and closure system. Packaging suppliers typically provide:

• polymer single-dose containers (and sealing films or cap systems)
• in-line serialization and packaging formats for distribution

3) Labeler/holder vs. manufacturing site split

The party marketing Pulmicort under the label may not be the same entity manufacturing at every site or for every strength.

What excipient suppliers support Pulmicort Respules suspension manufacturing?

Pulmicort Respules is an aqueous suspension and uses excipients that are common to inhalation suspensions, including viscosity and suspension agents, buffering agents, and tonicity control components. For supply continuity, sourcing risk usually centers on:

• suspension/dispersing system materials (control of particle size and re-suspendability)
• buffer and pH adjustment inputs that must meet tight specs
• sterilized or bioburden-controlled water systems and cleaning validation inputs
• single-dose container compatibility (chemical extractables/leachables and permeation)

Excipient supply is often multi-sourced, but regulatory and validation constraints can lock in specific grades and suppliers for a given manufacturing site.

Which companies supply budesonide drug substance for inhalation suspensions?

Budesonide is a steroid API with global sourcing across multiple API manufacturers. For Pulmicort-specific supplier mapping, the practical approach is:

• identify Pulmicort’s listed manufacturer(s) for each NDC strength and dosage form on FDA resources
• trace whether the labeled manufacturer uses in-house API or contract API procurement
• confirm through manufacturing site ownership or documented supplier qualification lists in regulatory submissions

Pulmicort Respules supply depends on both API availability and suspension formulation processing capacity.

How to map Pulmicort Respules suppliers by NDC, strength, and labeler (Orange Book method)?

Supplier mapping for a branded inhalation suspension is typically done by:

• pulling the product’s FDA listing (labeler, dosage form, strength, NDCs)
• cross-checking the Orange Book entry to identify the listed applicant/manufacturer(s)
• identifying current manufacturing/label-claim sites for each NDC
• using labeling and FDA inspection/manufacturing site records to confirm which sites handle fill-finish and packaging

This is the only reliable structure to identify “who supplies” because different strengths and pack configurations can have different manufacturing sites even under the same brand.

What packaging and respule unit-dose suppliers create the biggest supply constraints?

For unit-dose inhalation suspensions, the most constrained components are usually:

• single-dose container resins and molded parts
• sealing films/caps with verified extractables/leachables
• sterile filtration and cleaning system components at fill-finish lines

Even when API is available, shortages in container/closure supply can halt fill-finish. Packaging components also drive lead time due to qualification cycles.

Does Pulmicort Respules have multiple manufacturers, or a single CMO supply model?

Branded inhalation suspensions frequently use:

• primary manufacturer for routine production
• secondary manufacturer(s) for surge capacity and regional distribution
• line-level allocation for packaging configurations

Whether Pulmicort uses one vs multiple manufacturers is NDC-specific and must be verified via FDA listing/manufacturer fields for each strength and configuration.

Which generic or authorized-equivalent competitors share the same supplier base?

Companies making authorized generics or AB-rated generics for budesonide inhalation suspension often procure the same excipient grades and may use similar container systems, but they usually operate with different CMOs and different packaging lines.

A shared supplier base is most likely at the packaging component tier and excipient tier, not necessarily at the filled-dose tier.

What supplier risk exists for budesonide respules supply (lead times, bottlenecks, and recalls)?

The most common supply-risk drivers for this product category:

• unit-dose packaging qualification and resin supply disruptions
• suspension processing capacity constraints (dispersion, filtration, fill-finish schedules)
• API availability for budesonide during global capacity events
• logistics constraints for cold-chain-like controls are not usually primary here, but controlled-room/storage and validated shipping conditions still matter

Key Takeaways

• Pulmicort Respules supplier structure has four nodes: API, suspension fill-finish manufacturing, unit-dose container/closure packaging, and labeling/market authorization entity.
• Reliable supplier identification requires NDC-by-NDC mapping using FDA product listings and Orange Book manufacturer fields.
• Packaging components for respules are often the highest lead-time constraint because qualification and compatibility testing are rigid.
• Without NDC-level specificity for Pulmicort Respules strengths/configurations, a complete, accurate supplier list cannot be produced.

FAQs

1. Who manufactures Pulmicort Respules for each NDC strength?
2. Which company supplies the unit-dose respules container and sealing film for budesonide inhalation suspension?
3. Is the budesonide drug substance for Pulmicort made in-house or by an external API supplier?
4. Do excipient suppliers differ by manufacturing site for Pulmicort Respules?
5. Which supply bottleneck is most likely to affect Pulmicort Respules continuity: API, fill-finish, or respule packaging?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-06-13).
2. U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-06-13).