CLINDAMYCIN HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA	Pharmacia & Upjohn Company LLC	0009-0225-02	100 CAPSULE in 1 BOTTLE (0009-0225-02)	1970-05-22
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA	Pharmacia & Upjohn Company LLC	0009-0331-02	100 CAPSULE in 1 BOTTLE (0009-0331-02)	1970-05-22
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA	Pharmacia & Upjohn Company LLC	0009-0395-14	100 CAPSULE in 1 BOTTLE (0009-0395-14)	1970-05-22
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-3328-1	100 CAPSULE in 1 BOTTLE (59762-3328-1)	1970-05-22
Pfizer	CLEOCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	050162	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-5010-2	100 CAPSULE in 1 BOTTLE (59762-5010-2)	1970-05-22
Aurobindo Pharma	CLINDAMYCIN HYDROCHLORIDE	clindamycin hydrochloride	CAPSULE;ORAL	065442	ANDA	Major Pharmaceuticals	0904-7194-61	100 BLISTER PACK in 1 CARTON (0904-7194-61) / 1 CAPSULE in 1 BLISTER PACK	2009-08-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Suppliers for Clindamycin Hydrochloride (API, Generics, Contract Manufacturing)

Clindamycin hydrochloride is widely supplied as an antibiotic API and as finished-dose generics. The commercial supplier set is dominated by Indian and Chinese API manufacturers plus global sterile/injectable and oral-solid finished-dose players. Below is a supplier-and-IP risk oriented market map focused on what buyers typically need: API sources, finished-dose sources, and the manufacturing/IP constraints that affect procurement and launch timing.

Which companies supply clindamycin hydrochloride as an API?

Clindamycin hydrochloride API sourcing is concentrated in Asia, with multiple producers supplying both branded and generic finished dosage forms. Buyers typically source via:

API distributors (for immediate availability and testing batches)
direct API manufacturers (for volume pricing and long-term supply)
toll or contract API manufacture (where specs or DMF linkage is required)

API supply landscape (typical procurement regions)

India: heavy participation in clindamycin API and intermediates, with broad documentation packages for generic customers.
China: large-capacity production of antibiotics, including clindamycin intermediates and API.
EU/US: smaller share for API versus finished-dose, but some firms supply intermediates, specialty grades, or act as QA/testing partners for US distribution.

What to ask in RFQs for clindamycin HCl API

DMF/ASMF availability (US and/or EU) and whether the supplier can support RLD or generic filing needs
Typical specs: assay method, impurities profile, polymorph/particle size controls (if relevant to customer formulation)
Sterility grade requirements do not apply to API, but endotoxin limits may be relevant if upstream handling affects injectable formulations
Packaging and re-test periods for stability planning

Who manufactures clindamycin hydrochloride finished dosage forms in the US?

US market access for clindamycin is mainly through generic oral capsules/tablets and generic injectable products. Finished-dose sourcing depends on the dosage form:

Oral: capsules and topical/gel products use different manufacturing and regulatory documentation.
Injectable: higher compliance burden (aseptic processing, endotoxin control, container closure systems).
Topical: different formulation and stability requirements, even when the active is clindamycin HCl.

US distribution pattern

Branded availability is limited versus generic penetration.
Multiple ANDA holders cover each dosage form, which drives supplier competition but increases the need to confirm whether the API source ties to DMF references used in each filing.

What Orange Book status applies to clindamycin hydrochloride products?

Clindamycin hydrochloride is an established generic antibiotic in many dosage forms, and most products are past primary exclusivity windows. Orange Book listings for each strength and dosage form typically show:

existing patents (if any late-life formulation/manufacturing patents persist for specific products)
expiration status that is often aligned with the age of the products

Procurement implication

Orange Book status matters less for API procurement and more for:

finished-dose formulation selection
ANDA paragraph IV / 505(b)(2) differentiation strategies
licensing and challenge posture for specific NDCs

When do clindamycin hydrochloride products lose exclusivity (and why does it matter to suppliers)?

For established antibiotics, exclusivity and patent coverage are usually driven by:

formulation patents tied to a specific dosage form (release profile, excipients, manufacturing process)
manufacturing site or process patents
packaging/container closure patents (especially for injectables)

Supplier risk

Even when API is commoditized, finished-dose IP can constrain:

contract manufacturing acceptance for specific NDC projects
ability to source a particular API grade if it impacts impurity profiles tied to the approved method

What patents protect clindamycin hydrochloride formulations (and how do they affect sourcing)?

Most clindamycin formulation IP is product-specific rather than active-ingredient-wide. Common claim themes in historical antibiotic formulation estates include:

granulation and compression processes for oral solids
stability improvements tied to excipient systems
aseptic manufacturing process controls for injectable products
packaging and container closure systems

Sourcing impact

If a finished-dose maker has an active process or formulation patent, contract manufacturers and API suppliers may face:

constraints on process transfer
documentation and change-control requirements for API impurity profile alignment

What generic entry risks exist for clindamycin hydrochloride (Paragraph IV, litigation, exclusivity)?

Clindamycin hydrochloride is usually not a typical high-stakes Paragraph IV target compared with newer drugs, but it can still present risks where:

an ANDA holder has a still-enforced patent on a specific strength/dosage form
a settlement restricts certain carve-outs by NDC or product configuration
a product has a late-expiring formulation patent (less common, but possible for complex injectables)

Procurement impact

Buyers choosing a finished-dose supplier should diligence:

whether the supplier’s NDC is tied to an enforceable patent
whether there are restrictions in supply agreements linked to specific launch or litigation posture

Which companies are challenging or litigating clindamycin hydrochloride patents?

Litigation is typically product- and NDC-specific. For a procurement decision, the practical approach is:

identify the NDC(s) needed
check which ANDA holders are active in the Orange Book’s patent list for those NDCs
assess whether any disputes could affect supply continuity

Supplier continuity risk

Even if the API is available, litigation can create:

restricted manufacturing authorization
supply pauses tied to enforcement actions
re-qualification delays after process changes

What delivery forms have different supplier sets for clindamycin hydrochloride?

Clindamycin hydrochloride is used across multiple delivery forms, each with distinct supplier ecosystems:

Oral solids

Capsules and tablets require formulation and compression/susceptibility management.
API grade needs compatibility with impurity specs and stability design.

Injectables

Aseptic manufacturing means a narrower set of qualified contract manufacturers.
Container closure and leachables/extractables programs matter.

Topicals (cream/gel/other)

Separate formulation line, stability program, and packaging.
Even when clindamycin HCl is the active, sourcing depends on excipient compatibility and manufacturing controls.

How does clindamycin hydrochloride API quality differ across suppliers (what buyers should validate)?

Clindamycin API is sensitive to impurity profiles and may vary across production routes. Buyers should validate:

impurity thresholds and identification methods
polymorphic/particle size impacts on blending uniformity for solids
residual solvents from synthesis route
stability under planned storage and retest intervals

Batch acceptance and change control

For long-term supply agreements, buyers typically require:

defined change control triggers for synthesis route changes
notification windows for process adjustments that may shift impurities

Which contract manufacturing organizations can produce clindamycin hydrochloride (and what do they need)?

Contract manufacturing for clindamycin typically focuses on:

oral solid dosage manufacturing with validated compression and coating lines
sterile injectable manufacturing with aseptic rooms, sterilization controls, and QC release workflows
formulation development for generic lifecycle support

What matters in CMO selection

ability to support DMF-linked specifications
stability-indicating method compatibility
prior experience with clindamycin impurity patterns
ability to run technology transfers without invalidating the approved comparability plan

How do supply agreements for clindamycin hydrochloride usually structure risk?

Common commercial terms for antibiotic supply include:

forecasted volumes with buy-down and buy-out clauses
impurity and assay acceptance windows
allocation rules in shortages
change control obligations tied to regulatory filings
lead-time commitments with penalties for late delivery (especially injectable lines)

Regulatory documentation alignment

Certificates of Analysis and batch traceability are standard.
For finished doses, the supplier must align with the approved dossier methods and specifications, which can indirectly constrain API selection.

Which supplier categories reduce lead times for clindamycin hydrochloride?

Three sourcing routes usually win on time-to-availability:

API distributors with inventory
- Best when qualification is already completed or where buyers use supported analytical methods.
Finished-dose suppliers with established US NDC supply
- Best for procurement of finished goods rather than API.
CMOs already qualified on clindamycin-specific manufacturing lines
- Best when customers need custom batch sizes or formulation support under controlled change processes.

Commercial exposure: where procurement can break first for clindamycin hydrochloride

Even when API is available, the binding constraints often move to:

sterile injectable capacity
packaging and container closure procurement
stability testing throughput
regulatory release timing for batches

Implication

A buyer’s continuity risk often depends on finished-dose manufacturing constraints rather than clindamycin API availability.

Key Takeaways

Clindamycin hydrochloride is broadly supplied, with API sourcing concentrated in India and China and finished-dose supply led by multiple US generic makers.
API procurement is typically easier than injectable finished-dose procurement due to aseptic manufacturing capacity and release constraints.
Orange Book status and product-specific patents matter for finished-dose selection, not for basic API availability.
The main procurement risks are batch acceptance, impurity specification alignment, and finished-dose manufacturing interruptions tied to quality or regulatory constraints.

FAQs

1) Which is easier to source for procurement, clindamycin hydrochloride API or injectable finished dose?
API is generally easier to source; injectables are constrained by aseptic manufacturing and QC release capacity.

2) Do clindamycin hydrochloride API suppliers usually provide DMF/ASMF support?
Many do, but the availability is product- and supplier-specific; buyers need documentation alignment for regulatory submissions.

3) How does API impurity profile affect generic clindamycin products?
Impurity profile variance can force formulation or analytical method adjustments and can affect batch acceptance under approved specifications.

4) Can contract manufacturers make clindamycin hydrochloride without prior clindamycin experience?
They can, but qualification and method/impurity alignment typically introduce longer validation timelines.

5) What delivery forms should be prioritized to minimize supply risk?
Oral solids often face fewer manufacturing constraints than injectables; topical supply depends on line clearance and stability programs.

References

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
FDA Drug Shortages database. U.S. FDA.
EMA Product-related documents and classification resources. European Medicines Agency.

Suppliers and packagers for generic pharmaceutical drug: CLINDAMYCIN HYDROCHLORIDE