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Suppliers and packagers for MINOCYCLINE HYDROCHLORIDE
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MINOCYCLINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 065470 | ANDA | A-S Medication Solutions | 50090-2579-0 | 60 CAPSULE in 1 BOTTLE (50090-2579-0) | 2008-03-11 |
| Aurobindo Pharma | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 065470 | ANDA | A-S Medication Solutions | 50090-2579-2 | 20 CAPSULE in 1 BOTTLE (50090-2579-2) | 2008-03-11 |
| Aurobindo Pharma | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 065470 | ANDA | A-S Medication Solutions | 50090-2579-3 | 30 CAPSULE in 1 BOTTLE (50090-2579-3) | 2008-03-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for MINOCYCLINE HYDROCHLORIDE
Who Supplies Minocycline Hydrochloride to the Pharmaceutical Market?
Minocycline hydrochloride is a mature antibiotic API with a broad global supply base. In practice, procurement falls into two buckets: (1) API manufacturers producing “minocycline hydrochloride” (typically in bulk API form), and (2) contract manufacturing/rep ackaging channels supplying finished-dose products or intermediate/granulated API blends under regulatory supply chains.
Below is a supplier map by supply type that aligns with typical sourcing workflows for minocycline hydrochloride in pharma and generics.
API suppliers: Which companies manufacture minocycline hydrochloride?
The following supplier set reflects the most common categories seen in API sourcing (Tier 1 API makers, specialty generics/API producers, and DCC-style intermediates depending on region). Names below are the companies that routinely appear as API/chemical producers for minocycline hydrochloride in regulatory and industry purchase channels.
Tier-1 API producers and specialty API manufacturers (global)
- Hetero Labs / Hetero Drugs (India)
- Cipla (India)
- Sun Pharmaceutical Industries (India)
- Dr. Reddy’s Laboratories (India)
- Aurobindo Pharma (India)
- Mankind Pharma (India)
- Cadila Pharmaceuticals (Zydus) (India)
- Lupin (India)
- Zhejiang Hisun Pharmaceutical (China)
- Sino? (China-based antibiotic API producers)
Specialty fine-chemical and antibiotic-API producers (China/India and EU-origin supply chains)
Commonly sourced from manufacturing networks that produce tetracycline-class intermediates and API salts, including minocycline hydrochloride, often supplied via:
- China-based API plants (including Zhejiang/Jiangsu supply corridors)
- Indian API plants focused on antibiotic APIs and solids manufacturing
Procurement reality: for minocycline hydrochloride, many buyers obtain supply through intermediates or distribution arms even when the underlying manufacture sits at an API plant.
Finished-dose suppliers: Who supplies minocycline hydrochloride products to pharmacies?
Minocycline hydrochloride is the active ingredient in multiple branded and generic finished dosage forms (capsules and tablets are most common). Finished-dose suppliers often include the same large generics companies that also supply API or sourced API.
Finished-dose brands and generics (commonly marketed by large generics houses)
- Par Pharmaceutical (generic supply chain in the US)
- Teva (generics)
- Mylan / Viatris (generics)
- Dr. Reddy’s (generics)
- Sandoz (generics)
- Amneal (generics)
- Camber / Lannett / Heritage-type channels (US distribution for older antibiotic SKUs via generics manufacturing partners)
Finished-dose supply often runs on older ANDA products; procurement can shift based on packaging and market share rather than API availability alone.
How to qualify minocycline hydrochloride suppliers (what matters in tenders)
Procurement qualification for minocycline hydrochloride typically hinges on three technical control points: regulatory standing, quality system maturity, and impurity profile control.
Quality system and compliance checkpoints
- GMP manufacturing status for API (or equivalent for the facility supplying the salt/API)
- Batch release documentation availability (CoA, impurity report, residual solvents)
- Stability and retest period support for the marketed shelf life
- Analytical methods: HPLC/UV identity and potency; impurity and degradation method validation
Product specifications commonly requested for minocycline hydrochloride API
Typical commercial requirements include:
- Assay/potency (minocycline hydrochloride content at release)
- Related substances (impurity limits for oxidation, epimers, and process impurities)
- Water content (Karl Fischer or equivalent)
- Residual solvents (ICH Q3C compliant where applicable)
- Heavy metals (ICH Q3D where applicable)
- Microbiological limits (if supplied in formats where required by the receiving process)
Which supplier profiles dominate minocycline hydrochloride procurement?
In sourcing minocycline hydrochloride, the supplier landscape is usually dominated by:
- Large Indian and US/EU generics houses with internal QA and controlled vendor networks.
- China API producers supplying bulk API to global distributors, then to finished-dose manufacturers.
- Specialty distributors acting as the commercial interface while the manufacturing source sits at an API plant.
Key sourcing tactics for minocycline hydrochloride
1) Dual-source for price and continuity
Minocycline hydrochloride’s mature market means price can swing with supply tightness. Procurement teams generally maintain:
- one primary API source
- one alternate qualified source
2) Lock impurity profile early
For antibiotic salts, impurity profile changes can require requalification by the finished-dose manufacturer. Buyers typically:
- demand impurity comparability against prior lots
- require method harmonization or bridging when changing sources
3) Ensure salt form control
Minocycline hydrochloride must be supplied as the hydrochloride salt with consistent solid-state attributes (e.g., crystallinity, particle size distribution where specified). Buyers should specify:
- polymorph/crystal form controls if required for the downstream process
- sieve/PSD parameters if the finished-dose unit operation needs it
Key Takeaways
- Minocycline hydrochloride supplies are concentrated among major generics and specialty API manufacturers, with India and China representing the most common manufacturing geographies.
- Procurement success depends on API compliance package readiness (GMP status, CoA depth, impurity reporting) more than headline supplier brand names.
- Buyers typically manage continuity with dual-source qualification and protect downstream approvals by locking impurity profile and salt-form specifications early.
FAQs
1) Is minocycline hydrochloride sourcing mainly dominated by Asian API producers?
Yes. The bulk API supply chain for minocycline hydrochloride is heavily represented by India and China manufacturing networks, with global distributors feeding US/EU finished-dose producers.
2) Do finished-dose manufacturers always use the same supplier as their API source?
Not necessarily. Many finished-dose firms source API through qualified vendor networks, sometimes via distribution channels even when the underlying manufacture sits at an API plant.
3) What documentation is most important when qualifying a new minocycline hydrochloride API supplier?
A full CoA with impurity profile, residual solvents (as applicable), identity testing method, and stability/retest period support tied to the intended commercial retest window.
4) Why does impurity profile matter in minocycline hydrochloride procurement?
Because even with correct assay and identity, shifts in related substances can trigger comparability work and downstream revalidation for finished-dose product release.
5) What is the most common procurement strategy for minocycline hydrochloride?
Dual-source qualification with tight technical specifications and batch-to-batch comparability requirements.
References (APA)
[1] FDA. (n.d.). Drugs@FDA: Product and label information for approved drug products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency. (n.d.). European public assessment reports (EPARs) and assessment documentation. European Medicines Agency. https://www.ema.europa.eu/en/medicines
[3] ICH. (2005). ICH Q3A(R2): Impurities in new drug substances. International Council for Harmonisation. https://www.ich.org/
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