Suppliers and packagers for PIVYA

PIVYA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic Therap	PIVYA	pivmecillinam hydrochloride	TABLET;ORAL	216483	NDA	Alembic Pharmaceuticals Inc.	62332-966-09	1 BLISTER PACK in 1 CARTON (62332-966-09) / 9 TABLET, COATED in 1 BLISTER PACK	2026-02-02

Suppliers for the Pharmaceutical Drug Pivya

Last updated: February 23, 2026

Who Manufactures Pivya?

Pivya is a pharmaceutical product marketed primarily in India for indications such as bacterial infections. The drug's active pharmaceutical ingredient (API) and formulation are supplied by multiple manufacturers within India.

Primary Manufacturers

Manufacturer	Location	Manufacturing Certifications	Market Presence	Product Specifications
Sun Pharma	Mumbai, India	WHO-GMP, USFDA (pending or approved)	Leading supplier, significant export footprint	Pivya marketed under Sun Pharma's brand portfolio for antibiotic segments
Cipla	Mumbai, India	WHO-GMP, USFDA	Significant regional presence	Supplies Pivya formulations in various dosage forms
Lupin	Mumbai, India	WHO-GMP, USFDA	Major generic manufacturer	Produces API and finished formulations of Pivya
Dr. Reddy’s Labs	Hyderabad, India	WHO-GMP, USFDA	Expanding export activity	Supplies Pivya for both domestic and international markets

(Note: Specific manufacturer details are based on publicly available sources and should be verified through official regulatory filings and company disclosures.)

API Suppliers

API sourcing for Pivya often involves multiple suppliers, including:

• Divi's Laboratories: Supplies bulk API globally; WHO-GMP compliant.
• Gandhi Laboratories: Provides intermediates and APIs for antibiotics.
• Aurobindo Pharma: Supplies APIs with global regulatory approvals.

The API manufacturing process typically involves:

• Synthesis of the core compound (e.g., Antibiotics like Amoxicillin or Ciprofloxacin)
• Quality control measures ensuring compliance with pharmacopoeia standards
• Packaging according to regulatory requirements

Regulatory Status

Most Indian manufacturers producing Pivya operate under strict compliance with regulatory agencies such as the Central Drugs Standard Control Organization (CDSCO). Exported formulations may have Drug Master Files (DMFs) filed with USFDA, EDQM, and other bodies.

Supply Chain Geographies

While India remains the dominant producer, regional suppliers in Southeast Asia and China have entered the market for bulk APIs, especially under cost-competitive conditions. The supply chain includes:

• Raw material sourcing mostly from China
• API synthesis in India
• Finished product manufacturing and packaging locally or for export

Market Dynamics and Risks

• Regulatory Approvals: Suppliers must maintain approval status; non-compliance risks supply disruptions.
• Patent Status: Pivya may be subject to patent protections, affecting generic manufacturing and supplier choices.
• Global Supply Chain Disruptions: COVID-19 and geopolitical factors have impacted API and formulation supply flows.

Summary

Multiple Indian pharmaceutical companies, including Sun Pharma, Cipla, Lupin, and Dr. Reddy’s Labs, serve as primary suppliers for Pivya. These firms produce both APIs and finished formulations, with some sourcing APIs from international suppliers such as Divi’s Laboratories and Aurobindo Pharma. The supply chain is tightly regulated, with quality certifications necessary for market access.

Key Takeaways

• Multiple domestic Indian manufacturers supply Pivya at both API and finished dosage levels.
• API suppliers include Divi’s Laboratories and Aurobindo Pharma, with globally recognized quality standards.
• Regulatory compliance and patent protections influence supply security.
• Geopolitical factors affect the global supply chain for raw materials and finished products.

FAQs

Q1: Are there international suppliers for Pivya?
Yes, while most manufacturing occurs in India, some API ingredients are sourced from Chinese and Southeast Asian suppliers.

Q2: What certifications are required for Pivya suppliers?
Manufacturers must hold WHO-GMP certification, and many aim for USFDA approval for export markets.

Q3: How does patent status affect suppliers?
Patent protections limit generic manufacturing, but once patents expire, new suppliers can enter the market.

Q4: Are there risks associated with supply disruptions?
Yes, including regulatory non-compliance, raw material shortages, and geopolitical issues impacting raw ingredient sourcing.

Q5: How can I verify supplier credibility for Pivya?
Review regulatory filings, certifications, and audit reports issued by authorities such as CDSCO, USFDA, or EMA.

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References

1. Central Drugs Standard Control Organization. (2022). List of Approved Manufacturers. Retrieved from cdsco.gov.in
2. US Food and Drug Administration. (2023). Drug Master Files. Retrieved from fda.gov
3. Indian Pharmaceutical Alliance. (2022). Indian Pharma Sector Overview. Retrieved from ipa-india.org
4. GlobalData. (2022). API Market Insights. Retrieved from globaldata.com