Suppliers and packagers for SUMYCIN

SUMYCIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Strides Pharma Intl	SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147	ANDA	Pharmaka Generics Inc.	82644-087-60	60 TABLET, FILM COATED in 1 BOTTLE (82644-087-60)	2024-01-19
Strides Pharma Intl	SUMYCIN	tetracycline hydrochloride	TABLET;ORAL	061147	ANDA	Pharmaka Generics Inc.	82644-870-60	60 TABLET, FILM COATED in 1 BOTTLE (82644-870-60)	2024-01-19

Suppliers and packagers for SUMYCIN

Last updated: June 14, 2026

SUMYCIN (sumycin) suppliers: API and finished-dose sources, contract manufacturing, and distribution landscape

SUMYCIN is the trade name commonly used for tetracycline (tetracycline hydrochloride) in multiple markets. Supplier mapping depends on whether the request targets API (tetracycline HCl) or finished-dose SUMYCIN tablets/capsules in a specific country.

What companies supply SUMYCIN (tetracycline) API and finished doses?

SUMYCIN is not a single-source proprietary brand with a stable, universally published supplier list across geographies. In practice, market supply is split between:

• API suppliers of tetracycline hydrochloride (global fine-chemical manufacturers)
• Finished-dose manufacturers producing tetracycline formulations sold under the SUMYCIN brand by local label holders/distributors
• Wholesalers and importers supplying branded and generic tetracycline to pharmacies

API supply chain for tetracycline hydrochloride

Typical upstream players in tetracycline supply include global antibiotic API manufacturers and scale-up CDMOs that historically support tetracycline-family production (fermentation-derived actives or semi-synthesis chains). The set of qualified API suppliers changes by:

• regulatory status (DMF/CEP/inspections)
• antibiotic stewardship rules
• country-specific tenders and purchasing lists
• supply continuity and compliance history

Finished-dose manufacturing vs brand distribution

Where SUMYCIN is sold under a local brand, the “supplier” is often one of:

• the marketing authorization holder (MAH)/brand owner in that market
• a licensed finished-dose manufacturer under contract
• an importer/wholesaler when production is offshore

Without a market/country anchor, any named list risks mixing suppliers for different “SUMYCIN” spellings, strengths, dosage forms, and regulatory authorizations.

Which suppliers are approved for tetracycline and can they be verified in regulatory systems?

To verify supplier eligibility, buyers typically check:

• FDA: Drug master files (DMFs), approved NDA/ANDA manufacturing sites, and labeling manufacturing statements
• EMA and EU systems: CEP holder data and GMP certificate scope
• PIC/S-aligned GMP inspection results
• WHO-prequalified listings where applicable for public procurement
• country-specific medicines agencies for MAH and manufacturing site disclosures

How buyers validate SUMYCIN supply risk

Validation usually includes:

• matching the intended strength and salt (tetracycline base vs tetracycline HCl)
• confirming GMP site inspection status
• confirming lot release testing arrangements
• checking whether the supplier is the site that appears on the finished product label versus a downstream distributor

Do SUMYCIN suppliers differ by country or by dosage form (tablets vs capsules vs syrup)?

Yes. Supplier rosters shift based on:

• whether the marketed product is branded (SUMYCIN as the trade mark) or a generic tetracycline product sold under that name
• availability of local formulation capacity for tetracycline salts
• pediatric formulations and excipient constraints
• import licensing rules

Common dosage form splits

Even within “tetracycline” brands, the market can split into:

• tablets/capsules (more standardized manufacturing)
• liquid suspensions/syrups (higher formulation complexity, preservative/excipient differences)
• higher strengths that concentrate demand into fewer plants

What is the Orange Book or comparable status of SUMYCIN suppliers for generics?

SUMYCIN as a historical tetracycline brand typically does not map cleanly to a single modern US exclusivity or patent estate. In the US, tetracycline products are often treated as older, non-biologic small molecules where:

• generic manufacturers are longstanding
• product-by-product ANDA status and listed manufacturing sites vary by NDC and strength
• the key diligence is the current FDA-approved product listing and the manufacturing site(s) on the label

Which companies supply tetracycline hydrochloride API for global antibiotic markets?

The global tetracycline API market includes multiple established API producers and antibiotic-manufacturing clusters. Supplier qualification depends on:

• the salt form (hydrochloride versus other salts)
• impurity profiles
• pharmacopoeial compliance for tetracycline content and related substances
• analytical method equivalency and change control systems

How strong are manufacturing/IP barriers for SUMYCIN (tetracycline) sourcing?

For tetracycline, IP barriers are usually low relative to modern biologics or novel small molecules because:

• tetracycline’s core compound is long-established
• most supply is generic and formulation patents, when present, tend to be narrow and local
• the dominant barriers are regulatory and manufacturing capability, not blocking patents

In practice, procurement issues are more often:

• GMP inspection outcomes
• antibiotic supply constraints
• warehouse/lot release delays
• quality deviations leading to short-term supply shortages

What generic entry risks exist for SUMYCIN (tetracycline) from new manufacturers?

New entrants typically face:

• limited ability to demonstrate consistent impurity profiles and stability
• the need for updated GMP compliance for antibiotic APIs
• supply chain fragility in fermentation or key intermediate steps
• compressed timelines driven by procurement tenders

Risk is less about “legal entry” and more about “qualification and supply stability.”

Key supplier diligence checklist for SUMYCIN tetracycline procurement

Procurement and regulatory teams typically require supplier evidence for:

• COA and batch release methodology for tetracycline content/related substances
• stability data aligned to marketed dosage form
• regulatory traceability: DMF/CEP where relevant and matching manufacturing sites
• GMP certificate scope covering the exact product category and site activities
• change control history for API source, synthesis routes, and key intermediates

Key Takeaways

• “SUMYCIN suppliers” depends on whether the target is API (tetracycline hydrochloride) or the finished-dose SUMYCIN product and on the market/country.
• In most jurisdictions, tetracycline supply is dominated by qualified generic API and contract or licensed finished-dose manufacturers, with distribution handled by local MAHs and wholesalers.
• Supplier risk is driven mainly by GMP qualification, lot release consistency, and supply continuity, not by broad patent exclusivity.

FAQs

1. How do I verify who manufactures the finished SUMYCIN product in my country?
2. What documentation is required to qualify an API supplier for tetracycline hydrochloride?
3. Can multiple API suppliers be used to support SUMYCIN supply continuity under GMP?
4. How do impurities and related substances affect tetracycline API acceptance?
5. What are the most common reasons for tetracycline supply disruptions during procurement?

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book database).
2. U.S. FDA. Drug Master Files (DMF) database and DMF guidance materials.
3. EMA. European public assessment reports (EPAR) and quality/gmp information for centrally authorized products.