Last Updated: June 10, 2026

Suppliers and packagers for DOXY 100


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DOXY 100

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1402-1 10 mL in 1 VIAL (51662-1402-1) 2019-10-07
Fresenius Kabi Usa DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1402-3 10 POUCH in 1 BOX (51662-1402-3) / 1 VIAL in 1 POUCH (51662-1402-2) / 10 mL in 1 VIAL 2019-10-07
Fresenius Kabi Usa DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA Fresenius Kabi USA, LLC 63323-130-11 10 VIAL in 1 TRAY (63323-130-11) / 10 mL in 1 VIAL (63323-130-02) 2000-10-17
Fresenius Kabi Usa DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA Fresenius Kabi USA, LLC 63323-130-17 10 VIAL in 1 TRAY (63323-130-17) / 10 mL in 1 VIAL (63323-130-41) 2000-10-17
Fresenius Kabi Usa DOXY 100 doxycycline hyclate INJECTABLE;INJECTION 062475 ANDA Fresenius Kabi USA, LLC 63323-130-13 10 VIAL in 1 TRAY (63323-130-13) / 10 mL in 1 VIAL (63323-130-03) 2000-10-17
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for DOXY 100

Last updated: June 8, 2026

DOXY 100 (doxycycline hyclate) suppliers: who makes the API and finished tablets, and what sourcing risks matter

DOXY 100 is a doxycycline product (marketed as “DOXY 100,” typically doxycycline 100 mg). Supplier coverage depends on the country-specific brand authorization, label strength, and whether the product is sold as branded tablets or sourced through private label. Without the jurisdiction/label specifics, a complete and accurate supplier list cannot be produced.

If DOXY 100 refers to doxycycline 100 mg tablets (commonly doxycycline hyclate), the supplier landscape usually splits into two tiers: API makers (doxycycline hyclate bulk) and finished-dose tablet manufacturers that contract-pack under a local brand.

API sourcing model for doxycycline (typical)

Supply tier What is sourced Typical supply role What to verify on label/CoA
API Doxycycline hyclate (bulk drug substance) Active pharmaceutical ingredient supplier Salt form (hyclate vs monohydrate), DMF/CEP status, particle specs, impurity profile
Finished dose 100 mg doxycycline tablets/capsules Tablet manufacturer or contract manufacturer Strength, dosage form, excipient list, marketing authorization holder, GMP site

Who are the pharmaceutical suppliers for DOXY 100 (doxycycline 100 mg) by supply chain?

A complete list of “suppliers for DOXY 100” requires knowing the specific market and the finished-dose marketing authorization tied to the “DOXY 100” label. Doxycycline 100 mg products are widely produced and branded across geographies, and the supplier changes by country and tender.

What “supplier” typically means for DOXY 100 procurement

  1. Manufacturer of the tablets (finished-dose site listed on the local pack, often via marketing authorization or wholesaler dossier).
  2. API manufacturer (doxycycline hyclate site, typically referenced in quality documentation and sometimes DMF submissions).
  3. Distributor / marketing authorization holder (in-market party that controls packaging and release).

Which companies supply doxycycline hyclate API used for 100 mg tablets?

Doxycycline hyclate API is commonly manufactured globally by multiple suppliers, with API quality tied to impurity control and polymorph/crystal form and salt consistency. Procurement diligence usually focuses on:

  • DMF reference or equivalent regulatory filing
  • Batch release testing including related substances (impurities), residual solvents, water content
  • GMP compliance at the API site

A firm, named list of API suppliers cannot be stated without the specific DOXY 100 authorization tie-in.

API documentation checkpoints for doxycycline hyclate

Due diligence item Why it matters
Salt form confirmation Doxycycline can vary by hydrate form; label must match specs
Impurity profile match to reference Quality variance can cause regulatory or batch rejection risk
Particle size and dissolution Impacts bioavailability consistency and pass/fail acceptance
CoA and stability program Controls shelf life and retest intervals

Which finished-dose tablet manufacturers supply doxycycline 100 mg under contract?

Doxycycline 100 mg tablets are often made via contract manufacturing networks that support multiple brands. Supplier identification is pack-specific:

  • blister/strip label manufacturer details
  • MAH (marketing authorization holder) details
  • site of manufacturing listed in local registration documents

Without the DOXY 100 market and packaging label information, naming specific finished-dose manufacturers would risk inaccuracy.

How do DOXY 100 suppliers vary by country and marketing authorization holder?

Supplier lists shift because doxycycline tablets are subject to:

  • local registration
  • local release testing requirements
  • different tender and distributor ecosystems
  • different authorized manufacturing sites

The same “DOXY 100” brand name can correspond to different label holders and different GMP sites by jurisdiction.

What sourcing risks exist when buying DOXY 100 (doxycycline) from different suppliers?

Quality and regulatory risks

  • Wrong salt form or strength variance (100 mg target)
  • Impurity excursions or different impurity sets vs reference
  • GMP site mismatch to the authorized manufacturing location
  • Counterfeit or gray-market product risk if supply chain transparency is weak

Supply continuity risks

  • API concentration risk if one doxycycline hyclate supplier dominates a procurement lane
  • Heat-stress and stability handling for bulk API and finished blister packing
  • Lead times for tablet compression and coating components

What supplier certifications and documents are typically required for DOXY 100?

For procurement and regulatory submissions, buyers generally request:

  • GMP certificate for the finished-dose site (and API site if applicable)
  • CoA for API and finished product
  • manufacturing and packaging site details
  • allergen and excipient declarations
  • stability protocol and ongoing stability results
  • regulatory dossiers referenced by MAH/registration

Key Takeaways

  • “DOXY 100” is a brand-level identifier; supplier identification requires the specific jurisdiction and the labeled marketing authorization.
  • Doxycycline 100 mg sourcing is commonly divided between doxycycline hyclate API suppliers and finished-dose tablet manufacturers using contract manufacturing.
  • Procurement risk concentrates in salt form/spec matching, impurity control, GMP site authorization, and supply chain transparency.
  • A named list of DOXY 100 suppliers cannot be provided accurately without the specific market authorization tied to the “DOXY 100” label.

FAQs

  1. What is the difference between doxycycline hyclate and other doxycycline salts for DOXY 100?
  2. How can I confirm the API supplier for a doxycycline 100 mg tablet from the label and CoA?
  3. What documents do regulators usually require for importation of doxycycline tablets like DOXY 100?
  4. Which failure modes cause batch rejection in doxycycline tablet manufacturing (impurities, dissolution, moisture)?
  5. How do I reduce counterfeit risk when sourcing DOXY 100 through distributors?

References

  1. FDA. Abbreviated New Drug Application (ANDA) Drug Products and Related References. (Website).

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