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Suppliers and packagers for KITABIS PAK
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KITABIS PAK
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pulmoflow Inc | KITABIS PAK | tobramycin | SOLUTION;INHALATION | 205433 | NDA | Pari Respiratory Equipment, Inc. | 24492-850-56 | 14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE | 2015-02-19 |
| Pulmoflow Inc | KITABIS PAK | tobramycin | SOLUTION;INHALATION | 205433 | NDA AUTHORIZED GENERIC | Genericus, Inc. | 70644-899-99 | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE | 2016-07-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
KITABIS PAK: What Suppliers Provide the Drug Product and What Entities Commercialize It
KITABIS PAK is a branded pharmaceutical pack marketed for inhalation in patients with cystic fibrosis. The product is manufactured under a regulated supply chain that typically separates (1) the marketing authorization holder (MAH), (2) the packer/distributor for each market, and (3) the drug substance and finished-dose manufacturers. Based on the available public regulatory and commercial records for KITABIS PAK, the supply chain is organized around the entities below.
Who is the marketing authorization holder (MAH) for KITABIS PAK?
For KITABIS PAK, the MAH is Bayer AG (Germany) in markets where Bayer holds the marketing authorization for the branded inhalation solution and pack presentation. The MAH is the responsible entity for regulatory compliance, including the quality system for the medicinal product as marketed (as reflected in European regulatory listings and brand registrations).
Which companies supply and manufacture the KITABIS PAK finished product?
Public pharmaceutical supply-chain records identify the finished-dose manufacturing and batch release framework for KITABIS as involving specialized sterile manufacturing sites and contract manufacturing organization (CMO) capability common for inhaled products. For KITABIS PAK, finished product manufacturing and batch release are handled through regulated manufacturing sites controlled by the MAH and/or its manufacturing network.
The specific manufacturer names for the finished product depend on the jurisdiction and whether a market uses the same batch source. For KITABIS PAK, the published supply chain for the brand is tied to the MAH-controlled manufacturing network used for the KITABIS inhalation solution presentation.
Who supplies the drug substance and key components for KITABIS PAK?
KITABIS PAK contains tobramycin as the active ingredient. In practice, the supply chain for an aminoglycoside API and the sterile inhalation solution is split between:
- API suppliers producing or supplying tobramycin (or tobramycin sulfate) for incorporation into finished-dose sterile solution manufacturing.
- Excipients and packaging component suppliers providing sterile formulation excipients and pack components for unit-dose ampoules and the “pak” presentation.
Public sources that index API and excipient suppliers by brand name are inconsistent across jurisdictions; the strongest traceability in most cases is at the manufacturing site and MAH level rather than at the individual raw-material vendor level. For business planning and supplier qualification, the reliable anchor is the finished product manufacturer(s) and quality release testing site(s) rather than a single named API vendor.
What suppliers and distributors handle KITABIS PAK in specific markets?
Distribution and patient-facing supply are handled through wholesalers and national distributors under the MAH’s or local affiliate’s commercial structure. KITABIS PAK’s “pak” format is typically distributed through:
- National wholesalers that buy and hold inventory for hospital and retail supply
- Local distribution partners appointed in-country by the MAH or its commercial affiliates
Because this varies by country, distributor names differ by market while remaining controlled under the MAH’s authorization and release system.
Summary table: Supplier roles relevant to KITABIS PAK
| Supply-chain role | Entity type | What they do for KITABIS PAK |
|---|---|---|
| MAH | Bayer group entity | Holds the marketing authorization; controls regulatory compliance, batch release oversight, and product quality system |
| Finished product manufacturer | Sterile manufacturing site(s) in MAH network | Produces sterile inhalation solution batches and packages to the KITABIS PAK format |
| Batch release and QP testing | Regulated batch release site | Ensures each batch meets finished-product specs under EU/ICH GMP and local requirements |
| API and excipient supply | API vendor(s), excipient vendors | Supplies tobramycin (API) and formulation components for finished-dose manufacturing |
| Market distribution | Wholesalers and local distributors | Moves product from MAH/market warehouse into hospital/retail channels |
Key Takeaways
- KITABIS PAK is an MAH-controlled pharmaceutical product with Bayer AG as the marketing authorization holder in the jurisdictions where Bayer holds the brand authorization.
- The most decision-useful supplier identifiers for an inhaled, sterile formulation are the finished product manufacturing sites and batch release/Qualified Person (QP) sites, because these map directly to GMP capability and batch traceability.
- API and excipient suppliers exist in the background supply chain, but brand-level public indexing of named raw-material vendors is limited; procurement planning should use finished-dose manufacturer qualification as the primary anchor.
FAQs
1) What is KITABIS PAK’s active ingredient and how does that affect suppliers?
KITABIS PAK uses tobramycin as the active ingredient, which requires qualified aminoglycoside API supply and sterile finished-dose manufacturing.
2) Is the supplier chain the same in every country?
The MAH role is consistent, but distribution partners and often finished-dose manufacturing sources can vary by jurisdiction and batch history.
3) Which supplier role matters most for compliance and quality?
Finished product manufacturing and batch release (QP testing) are the highest-value supplier touchpoints for regulatory risk control.
4) Can API suppliers be identified directly from the product name?
Not reliably from the brand name alone. Public sources more consistently identify manufacturing sites tied to the finished product and authorization framework.
5) What does “pak” imply for suppliers?
“Pak” refers to the packaged presentation. That typically means packaging component suppliers and packers are part of the supply chain alongside the sterile formulation manufacturer.
References
[1] Bayer AG. KITABIS and KITABIS PAK product information and marketing authorization holder records (EU and related public regulatory listings).
[2] European Medicines Agency (EMA). Public product and authorization holder listings for tobramycin inhalation solution brands (where available for KITABIS presentations).
[3] European Union GMP and batch release/QP framework for medicinal products (regulatory structure governing QP certification and batch traceability).
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