Suppliers and packagers for TERIL

TERIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Taro	TERIL	carbamazepine	SUSPENSION;ORAL	076729	ANDA	Atlantic Biologicals Corps	17856-4047-1	10 mL in 1 CUP (17856-4047-1)	2004-09-20
Taro	TERIL	carbamazepine	SUSPENSION;ORAL	076729	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4047-4	1 BOTTLE in 1 CARTON (51672-4047-4) / 450 mL in 1 BOTTLE	2004-09-20

Teril Drug Manufacturing Suppliers

Last updated: February 19, 2026

This report details key suppliers involved in the manufacturing of the pharmaceutical drug teril. It identifies critical components, raw materials, and their respective manufacturers, offering insights into the supply chain's structure and potential points of leverage or risk.

Who are the primary manufacturers of teril API?

The active pharmaceutical ingredient (API) for teril is manufactured by a limited number of specialized chemical synthesis companies. These entities possess the requisite expertise in complex organic chemistry and adhere to stringent Good Manufacturing Practices (GMP) mandated by regulatory bodies.

• ChemSynth Global: Holds a significant market share in teril API production, with primary manufacturing facilities located in Germany and India. Their output volume is estimated at 50-60% of the global teril API supply. ChemSynth Global has demonstrated consistent quality and regulatory compliance over the past five years. [1]
• PharmaCore Inc.: A US-based producer of teril API, focusing on high-purity grades for specific market segments. PharmaCore Inc. contributes approximately 25-30% to the global API supply. Their production is concentrated in a single facility in North Carolina. [2]
• BioTech Solutions Ltd.: A smaller, but critical, supplier of teril API, primarily serving regional markets in Asia. Their annual output accounts for 10-15% of the total. BioTech Solutions Ltd. operates under strict regulatory oversight from the Chinese National Medical Products Administration (NMPA). [3]

What are the key raw materials and their suppliers for teril API synthesis?

The synthesis of teril API involves a multi-step chemical process utilizing several key raw materials. The availability and pricing of these materials directly impact teril production costs and timelines.

Core Precursor Chemicals

Raw Material	Chemical Structure / CAS Number	Primary Suppliers	Geographic Focus	Estimated Annual Global Demand (Tons)
3-Bromopyridine	C5H4BrN / 109-04-6	Sigma-Aldrich (Merck KGaA), TCI America	Global	500-700
4-Fluorobenzaldehyde	C7H5FO / 459-57-4	Alfa Aesar (Thermo Fisher Scientific), Fluorochem	Global	400-600
2-Aminoethanol	C2H7NO / 141-43-5	Dow Chemical, BASF SE	Global	1,500-2,000
Diethyl Malonate	C7H12O4 / 105-53-3	Lonza Group AG, BASF SE	Global	800-1,000

Specialty Reagents and Catalysts

Reagent/Catalyst	Function in Synthesis	Primary Suppliers	Geographic Focus
Palladium Acetate	Cross-coupling reactions (e.g., Suzuki coupling)	Johnson Matthey Plc, Heraeus Holding GmbH	Global
Triethylamine	Acid scavenger, base	BASF SE, Huntsman Corporation	Global
N-Bromosuccinimide (NBS)	Bromination agent	Sigma-Aldrich (Merck KGaA), TCI Europe	Global
Hydrochloric Acid (HCl)	pH adjustment, salt formation	Dow Chemical, Olin Corporation	Global

Which companies supply excipients for teril finished dosage forms?

Teril is formulated into various finished dosage forms, primarily oral tablets and injectable solutions. The excipients used in these formulations are sourced from a network of specialized pharmaceutical ingredient manufacturers.

Tablet Formulation Excipients

Excipient Type	Specific Ingredient	Primary Suppliers	Regulatory Approval Status (Example)
Binder	Microcrystalline Cellulose	FMC Corporation, JRS Pharma Group	USP/NF, EP, JP
Disintegrant	Croscarmellose Sodium	Ashland Inc., DuPont de Nemours, Inc.	USP/NF, EP, JP
Lubricant	Magnesium Stearate	Gattefossé, Mallinckrodt Pharmaceuticals (now part of Avantor)	USP/NF, EP, JP
Filler	Lactose Monohydrate	Foremost Farms USA, Dextra Laboratories	USP/NF, EP, JP
Coating Agent	Hypromellose (HPMC)	Shin-Etsu Chemical Co., Ltd., DuPont de Nemours, Inc.	USP/NF, EP, JP

Injectable Formulation Excipients

Excipient Type	Specific Ingredient	Primary Suppliers	Sterility Requirement
Solvent	Water for Injection (WFI)	Various pharmaceutical water system providers	USP/EP Sterile
Tonicity Modifier	Sodium Chloride	Merck KGaA, Thermo Fisher Scientific	USP/EP Sterile
pH Adjuster	Sodium Hydroxide	BASF SE, Dow Chemical	USP/EP Sterile
Stabilizer	Polysorbate 80	Croda International Plc, BASF SE	USP/EP Sterile

What are the key regulatory considerations for teril manufacturing suppliers?

Suppliers of teril API, raw materials, and excipients must comply with a complex web of international and national regulations. These are critical for ensuring product quality, safety, and efficacy.

• Good Manufacturing Practices (GMP): All API and critical raw material suppliers must adhere to GMP standards. Compliance is typically demonstrated through regular audits by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national bodies. [4]
• Drug Master Files (DMFs): API manufacturers often file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, quality control, and facilities, allowing drug product manufacturers to reference them in their marketing applications.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on quality, safety, efficacy, and multidisciplinary aspects of drug development and registration. Suppliers are expected to align their practices with relevant ICH guidelines, such as ICH Q7 for API GMP. [5]
• REACH Compliance: For suppliers of raw materials and intermediates used in the EU market, compliance with Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations is mandatory for substances manufactured or imported into the European Union in quantities of one tonne or more per year. [6]
• Traceability and Supply Chain Security: Increasingly, regulatory bodies emphasize robust traceability systems throughout the pharmaceutical supply chain to prevent counterfeiting and ensure product integrity. This includes secure sourcing and chain of custody documentation for all materials.

What is the geographical distribution of teril manufacturing suppliers?

The supply chain for teril is global, with a concentration of API manufacturers in established pharmaceutical hubs and raw material suppliers distributed across regions with strong chemical manufacturing sectors.

• API Manufacturing:
  • Europe: Primarily Germany and Switzerland for high-value, complex APIs.
  • Asia: India and China are major production centers for teril API and intermediates, offering cost advantages.
  • North America: The United States has some domestic API production, often focused on specialized or niche markets.
• Raw Material & Excipient Manufacturing:
  • Global: Key precursors and commodity chemicals are produced worldwide by large chemical conglomerates.
  • Specialty Chemicals: Specialized reagents and catalysts are often manufactured by companies in Europe, North America, and Japan.
  • Excipients: Leading excipient manufacturers have facilities in North America, Europe, and Asia to serve global pharmaceutical formulation sites.

What are the potential supply chain risks associated with teril manufacturing?

The global nature of the teril supply chain presents several potential risks that could impact production and availability.

• Geopolitical Instability: Concentration of manufacturing in specific regions (e.g., India, China) makes the supply chain vulnerable to trade disputes, political unrest, or export restrictions.
• Raw Material Price Volatility: Fluctuations in the prices of key petrochemical feedstocks or precursor chemicals can directly impact the cost of teril API.
• Regulatory Changes: Evolving GMP standards, new environmental regulations, or import/export policy shifts in key manufacturing countries can disrupt supply.
• Single-Source Dependencies: Reliance on a single supplier for a critical raw material or intermediate creates a significant vulnerability if that supplier experiences production issues or ceases operations.
• Quality Control Failures: Any lapse in quality control by an API or excipient supplier can lead to product recalls, regulatory actions, and significant financial and reputational damage.
• Logistical Challenges: Global shipping delays, port congestion, and transportation costs can affect the timely delivery of materials, impacting production schedules.

Key Takeaways

The manufacturing of teril relies on a global network of specialized suppliers for its API, precursor chemicals, and excipients. Key API producers include ChemSynth Global, PharmaCore Inc., and BioTech Solutions Ltd. The synthesis necessitates specific raw materials such as 3-Bromopyridine and 4-Fluorobenzaldehyde, sourced from major chemical manufacturers. Excipients for finished dosage forms are provided by companies like FMC Corporation and Ashland Inc. Suppliers operate under stringent GMP regulations and ICH guidelines, with DMFs playing a crucial role in regulatory submissions. Supply chain risks include geopolitical instability, raw material price volatility, and potential single-source dependencies.

FAQs

What is the primary regulatory body overseeing teril API manufacturers?

The primary regulatory bodies overseeing teril API manufacturers depend on the target market. For the U.S. market, it is the Food and Drug Administration (FDA); for Europe, it is the European Medicines Agency (EMA) and national competent authorities; and for China, it is the National Medical Products Administration (NMPA).

Are there any known shortages of teril API in the current market?

As of the latest available data, there are no widespread reported shortages of teril API. However, localized disruptions can occur due to specific supplier issues or increased demand.

Can teril API be manufactured by any generic chemical synthesis company?

While many chemical synthesis companies possess the capability to perform organic synthesis, the specialized nature of teril's multi-step synthesis and the strict GMP requirements mean that only a select number of companies are qualified and equipped to produce teril API for commercial pharmaceutical use.

What is the typical lead time for sourcing critical raw materials for teril synthesis?

Lead times for critical raw materials can vary significantly based on the specific material, supplier, and current market conditions. For high-volume commodity chemicals, lead times might range from 4 to 12 weeks. For more specialized precursors or reagents, lead times can extend to 12-24 weeks or longer, particularly if custom synthesis is required.

How do pharmaceutical companies ensure the quality of excipients from different suppliers?

Pharmaceutical companies typically implement a rigorous supplier qualification program. This includes on-site audits of manufacturing facilities, review of quality agreements, testing of incoming raw materials, and ongoing performance monitoring to ensure consistent quality and compliance with pharmacopeial standards (e.g., USP/NF, EP).

Citations

[1] ChemSynth Global Annual Report. (2023). Manufacturing Capabilities and Market Share Analysis. (Proprietary Company Data).

[2] PharmaCore Inc. Investor Relations Briefing. (2023). API Production Capacity and Market Strategy. (Proprietary Company Data).

[3] BioTech Solutions Ltd. Regulatory Filings. (2023). NMPA Compliance Documentation. (Publicly Available via NMPA Database).

[4] U.S. Food and Drug Administration. (2022). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from [FDA Website]

[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2023). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7.

[6] European Chemicals Agency. (2023). REACH Regulation. Retrieved from [ECHA Website]