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Orchid Pharma’s API Facility in Tamil Nadu Gets USFDA Inspection Clearance

Synopsis:

Orchid Pharma’s Alathur API facility completed a USFDA inspection with seven minor observations, ensuring continued compliance. The facility also renewed its EU GMP certification. Read more..Orchid Pharma share price rose 1.2%, closing at ₹828.25 on the BSE after the announcement. Read less


Orchid Pharma Ltd. has successfully completed an inspection by the United States Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The inspection, which took place between 10 February and 18 February 2025, resulted in seven minor observations. None of these issues relate to data integrity, ensuring continued compliance with USFDA standards.

Also read: RITES Signs MoU with CWPRS for Water Resources & Infrastructure Projects

ORCHID PHARMA LIMITED

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801-34.45 (-4.12 %)

Updated - 30 April 2025
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Key Takeaways:

  • Orchid Pharma’s API facility in Alathur underwent a USFDA inspection from 10-18 February 2025.

  • The inspection resulted in seven minor observations, none concerning data integrity.

  • The facility retained its status as India’s only USFDA-approved site for sterile cephalosporins.

  • Orchid Pharma also renewed its European Union Good Manufacturing Practice (EU GMP) certification.

  • Orchid Pharma share price rose 1.2%, closing at ₹828.25 on the BSE after the announcement.

Also read: India Glycols Secures ₹1,264.2 Crore Ethanol Supply Order from OMCs

Orchid Pharma’s Alathur Facility Maintains Global Compliance

The Alathur facility plays a crucial role in Orchid Pharma’s manufacturing operations, particularly in the production of sterile cephalosporin antibiotics. This successful USFDA inspection ensures that the facility continues to meet international regulatory standards, reinforcing its position in key global markets.

In addition to the USFDA clearance, Orchid Pharma also renewed its European Union Good Manufacturing Practice (EU GMP) certification. This certification enables the company to maintain exports to European markets while adhering to stringent pharmaceutical manufacturing regulations.

Orchid Pharma’s USFDA Inspection Summary

Inspection Details

Outcome

Inspection Period

10-18 February 2025

USFDA Observations

7 minor issues

Data Integrity Concerns

None

Facility Certification

USFDA & EU GMP renewed

Speciality

Sterile cephalosporins

Impact on Orchid Pharma Share Price

Following the announcement of the successful inspection, Orchid Pharma share price saw a positive reaction in the stock market. The stock closed 1.2% higher at ₹828.25 on the BSE, reflecting investor confidence in the company’s regulatory compliance and international market stability.

With continuous adherence to global pharmaceutical standards, Orchid Pharma remains a key player in the API sector. The Orchid Pharma share price is expected to stay under close watch as the company strengthens its position in international markets.

Orchid Pharma’s ability to clear regulatory inspections and maintain international certifications reinforces its credibility in the global pharmaceutical industry. The successful USFDA inspection and EU GMP renewal further solidify its manufacturing capabilities, keeping its market outlook stable and investor confidence strong.

Also read: HFCL Secures Rs. 2,501.30 Crore BharatNet Phase-III Deal with BSNL

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This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

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