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Anuh Pharma's Good Manufacturing Practices (GMP) certificate withdrawn


Anuh Pharma Limited (APL) – a BSE only listed stock, is part of Mumbai based SK group of companies is a mid-sized player in the API/bulk drug industry and is engaged in manufacturing products such as: erythromycin and its salts, higher macrolides like azithromycin, roxithromycin etc, pyrazinamide, corticosteroids and chloramphenicol. APL’s manufacturing facility is located at Boisar, Thane District and has an annual capacity of 750 tones.

Anuh Pharma is one of the largest manufacturers of Macrolides and Anti-TB products in India, besides being a major player in Anti-bacterials, Anti-malarial, Anti-hypertension and Corticosteroids.

A few notes from the company’s annual report:

  • The Company derived ~48% of its revenues from exports in FY15-16.
  • The Company  has  strong  marketing  partnerships  with  350 customers  in  over  57  countries  including  Europe,  Mexico  and South Africa
  • Growth in 9MFY16 v/s 9MFY15 was led by approximately 55%increase in sales of erythromycin salts and a 22% increase in sales of pyrazinamide.
  • Revenue contribution from Erythromycin rose from 32% to 41% 9MFY16 v/s 9MFY15

The company has received GMP certifications for it’s from US FDA, UKMHRA, European Pharma Commission and Mexican Authorities. The company on the 7-Dec-15 received the GMP (Good Manufacturing Practice) Certificate from COFEPRIS (Health Authority of Mexico) and on the 16-Dec-15 it received World Health Organization (WHO) Prequalification for the product Sulfadoxine.

Anuh Pharma European Pharma Commission Certificate

Then ICRA on the 21-Dec-15 upgraded the rating to A1 from A2+ and reaffirmed it in early January, 2016. Though there was no mention of the company’s finances and product lines, there was no mention of any manufacturing related concerns that ICRA took into account. The outlook on the long term rating is stable.

However on the 15-Mar-16 the company announced that EDQM (European Directorate for the Quality of Medicines & HealthCare) Ad Hoc committee has taken the decision to suspend the certificate of suitability for Erythromycin Ethyl Succinate, Erythromycin and Pyrazinamide as well as close the application for a certificate of suitability of Erythromycin Stearate.

Here is what the company saidAccording to the resolution, they have given us the possibility to request a hearing in order to ask the EDQM Ad Hoc Committee to review its decision.

The Company is fully and wholly committed to GMP compliance. The Company appreciate the efforts of EDQM to ensure GMP compliance through the CEP programme and the Company wish to work in the spirit of partnership with EDQM. The Company is fully committed in resolving this issue at the earliest.

The Company do not expect significant effect on its top & bottom line since the Company have very good presence in Indian and rest of world’s market.

Today the French National Agency for Medicines and Health Products Safety suspended the GMP certificate issued to Anuh Pharma with the following reasoning:

Anuh Pharma GMP WIthdrawal

From the knowledge gained during the inspection conducted on the 12-Feb-16, it is considered that the company does not comply with the Good Manufacturing Practices.

The NCR applies to all active substances of the site. List of other active substances manufactured on the site: Ambroxol Hydrochloride, Azithromycin, Chloramphenicol, Chroramphenicol Palmitate, Ciprofloxacin HCI, Clarithromycin, Erythromycin, Erythromycin Estolate, Erythromycin Propinate, Erythromycin Stearate, Losartan Potassium, Piperaquine phosphate, Pyrazinamide, Roxythromycin, Sulfadoxine.

There were 24 deficiencies observed during the inspection and due to this, the certificate is being withdrawn, recall of all the products released from these contaminated batches, no further use of the active substances manufactured by the site.

The findings reveal a critical non-compliance of the quality system of the company as a whole. Moreover, due to the several lack of transparency of the company regarding its manufacturing activities, there is no assurance as regards to the origin of every batch of active substances claimed to have been manufactured by the company at the Boisar site. Consequently, it is considered that the identified risks are applicable to all active substances manufactured at the site.

Anuh Pharma GMP Non Compliance

This is how their sales panned out (period ending December, 2015):

Anuh Pharma Sales Mix



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Disclosure: The authors at Capital Mind have positions in the market and some of them may support or contradict the material given above, or may involve a direction derived from independent analysis.

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